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PT. KALBE FARMA TBK.

AUTO FREEZE DRYING Batch Report


Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section1:Overview

Catalog
No. Item Value
1 Section1 Section1:Overview
2 Section2 Section2:Freeze Drying Recipe
3 Section3 Section3:Operation Parameters
4 Section4 Section4:History trend

Machine Information
No. Item Value
1 Manufacturer Name IMA Life
2 Manufacturer Address 101 Wangjing LizeZhongYuan,Chaoyang,100102,Beijing,China
3 Web Site www.IMALife.com
4 Service Phone 86-10-64399688
5 Service Fax 86-10-64392556
6 Custom Name PT. KALBE FARMA TBK.

Batch Information
No. Item Value
1 Initiator Full Name SAHIDIN
2 Abortor Full Name
3 Product Name PRANZA 40 MG
4 Product Type Vial
5 Product Quantity 24840
6 Container Size 10
7 Container Quantity 24840
8 Container Fill Volume 3
9 Product Container Type Vial
10 Batch Name AFD20190704155459
11 Batch Series Number 1288
12 Batch Comments PRANZA 40 MG BN (VPRZA90060)
13 Batch Description 4-Jul-19
14 Batch Start Time 7/4/2019 15:54
15 Batch End Time 7/6/2019 15:07
16 Batch End Mode Normal
17 Report template name VIT_AFD

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Approved by Date Page: 1 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section2:Freeze Drying Recipe

Recipe Information
No. Item Value
1 Freeze Drying Recipe Name VPRZ1R
2 Freeze Drying Recipe Number 2030
3 Freeze Drying Recipe Description REDUCE TIME
4 Freeze Drying Recipe Comments PERUBAHAN WAKTU LIOFILISASI

General Parameters
No. Name High Limit Low Limit Value Unit
1 Control vacuum high deviation 1000 0 30 µBar
2 Control vacuum low deviation 1000 0 30 µBar
3 Control vacuum pre-alarm setpoint 1000 0 500 µBar
4 Control vacuum alarm setpoint 1000 0 600 µBar
5 Vacuum control gas selection - - Nitrogen -
6 Pre-aeration gas selection - - Nitrogen -

Step Parameters
Step
Step Step Vacuum Step Time
Step Name Temperature
No.
(°C) (µbar) HH:MM MM:SS
1 Loading 5 -- -- --
2 Freezing 5 -- 0 : 30 --
3 Freezing -45 -- 1 : 40 --
4 Freezing -45 -- 1 : 30 --
5 Evacuation -- 200 -- --
6 Drying 5 200 1 : 40 --
7 Drying 5 200 15 : 0 --
8 Drying 5 200 0:0 --
9 Drying 50 200 1 : 30 --
10 Drying 50 200 6:0 --
11 Moisture Test -- 10 -- 60 : 60
12 Pre-Aeration -- -- -- --
13 Stoppering -- -- -- 0 : 20
14 Aeration -- -- -- --
15 Storage 20 -- 15 : 0 --

The hour part of P.R.T time setpoint is test repeat time(minute),minute part is test time(second).

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Approved by Date Page: 2 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/4/2019 15:52:00 5.4 5.0 43.0 42.6 - 30 80 0 198
7/4/2019 15:53:00 4.8 5.0 43.0 42.6 - 30 80 0 199
7/4/2019 15:54:31 Audit: - Manual shelf temperature regulation is disabled by IDIN.
7/4/2019 15:54:35 Audit: - Manual control mode is de-activated by IDIN.
7/4/2019 15:54:39 Audit: - Auto control mode is activated by IDIN.
7/4/2019 15:54:59 Audit: - The auto freeze drying is started by IDIN.
7/4/2019 15:57:07 Event: - Step advanced to [1] Loading
7/4/2019 15:57:08 Alarm: CLOSE - Communication fail with SQL database.
7/4/2019 15:57:13 Audit: - A_SQLCOMMFAIL ALARM is acknowledged by IDIN.
7/4/2019 15:57:15 Audit: - Alarm is reset manually by IDIN.
7/4/2019 15:58:00 5.5 5.0 42.7 42.0 - - 80 0 210
7/4/2019 15:59:00 5.4 5.0 42.7 42.0 - - 80 0 212
7/4/2019 16:00:00 5.4 5.0 42.7 42.0 - - 80 0 215
7/4/2019 16:01:00 5.3 5.0 42.6 41.9 - - 80 0 216
7/4/2019 16:02:00 5.2 5.0 42.6 41.9 - - 80 0 219
7/4/2019 16:03:00 5.2 5.0 42.5 41.9 - - 80 0 220
7/4/2019 16:04:00 5.2 5.0 42.5 41.8 - - 80 0 223
7/4/2019 16:05:00 5.1 5.0 42.5 41.8 - - 80 0 225
7/4/2019 16:06:00 5.2 5.0 42.4 41.7 - - 80 0 227
7/4/2019 16:07:00 5.1 5.0 42.4 41.7 - - 80 0 229
7/4/2019 16:08:00 5.0 5.0 42.4 41.7 - - 80 0 230
7/4/2019 16:09:00 5.1 5.0 42.4 41.7 - - 80 0 233
7/4/2019 16:10:00 5.1 5.0 42.3 41.6 - - 80 0 234
7/4/2019 16:11:00 5.1 5.0 42.3 41.6 - - 80 0 237
7/4/2019 16:12:00 5.2 5.0 42.3 41.5 - - 80 0 240
7/4/2019 16:13:00 5.1 5.0 42.2 41.5 - - 80 0 241
7/4/2019 16:14:00 5.2 5.0 42.1 41.4 - - 80 0 243

-------------------------------------------
Approved by Date Page: 3 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/4/2019 16:15:00 5.0 5.0 42.1 41.4 - - 80 0 246
7/4/2019 16:16:00 5.1 5.0 42.1 41.3 - - 80 0 247
7/4/2019 16:17:00 5.1 5.0 42.1 41.3 - - 80 0 249
7/4/2019 16:18:00 5.2 5.0 42.0 41.3 - - 80 0 251
7/4/2019 16:19:00 5.1 5.0 42.0 41.2 - - 80 0 253
7/4/2019 16:20:00 5.1 5.0 41.9 41.2 - - 80 0 256
7/4/2019 16:21:00 5.1 5.0 41.9 41.2 - - 80 0 257
7/4/2019 16:22:00 5.2 5.0 41.8 41.1 - - 80 0 259
7/4/2019 16:23:00 5.1 5.0 41.8 41.1 - - 80 0 262
7/4/2019 16:24:00 5.2 5.0 41.8 41.1 - - 80 0 263
7/4/2019 16:25:00 5.1 5.0 41.7 41.0 - - 80 0 265
7/4/2019 16:26:00 5.1 5.0 41.7 40.9 - - 80 0 267
7/4/2019 16:27:00 5.1 5.0 41.7 40.9 - - 80 0 270
7/4/2019 16:28:00 5.2 5.0 41.7 40.9 - - 80 0 271
7/4/2019 16:29:00 5.1 5.0 41.6 40.9 - - 80 0 273
7/4/2019 16:30:00 5.1 5.0 41.6 40.8 - - 80 0 276
7/4/2019 16:31:00 5.2 5.0 41.5 40.8 - - 80 0 278
7/4/2019 16:32:00 5.1 5.0 41.5 40.7 - - 80 0 279
7/4/2019 16:33:00 5.2 5.0 41.4 40.7 - - 80 0 282
7/4/2019 16:34:00 5.1 5.0 41.4 40.7 - - 80 0 284
7/4/2019 16:35:00 5.1 5.0 41.4 40.6 - - 80 0 286
7/4/2019 16:36:00 5.1 5.0 41.3 40.6 - - 80 0 287
7/4/2019 16:37:00 5.1 5.0 41.3 40.5 - - 80 0 289
7/4/2019 16:38:00 5.2 5.0 41.2 40.5 - - 80 0 292
7/4/2019 16:39:00 5.2 5.0 41.2 40.5 - - 80 0 294
7/4/2019 16:40:00 5.2 5.0 41.2 40.4 - - 80 0 296
7/4/2019 16:41:00 5.1 5.0 41.1 40.4 - - 80 0 297

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Approved by Date Page: 4 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/4/2019 16:42:00 5.1 5.0 41.1 40.4 - - 80 0 299
7/4/2019 16:43:00 5.1 5.0 41.1 40.3 - - 80 0 301
7/4/2019 16:44:00 5.1 5.0 41.0 40.2 - - 80 0 303
7/4/2019 16:45:00 5.1 5.0 40.9 40.2 - - 80 0 306
7/4/2019 16:46:00 5.1 5.0 40.9 40.2 - - 80 0 308
7/4/2019 16:47:00 5.1 5.0 40.9 40.2 - - 80 0 310
7/4/2019 16:48:00 5.1 5.0 40.8 40.1 - - 80 0 312
7/4/2019 16:49:00 5.2 5.0 40.8 40.1 - - 80 0 314
7/4/2019 16:50:00 5.1 5.0 40.8 40.0 - - 80 0 315
7/4/2019 16:51:00 5.2 5.0 40.7 40.0 - - 80 0 317
7/4/2019 16:52:00 5.1 5.0 40.7 39.9 - - 80 0 321
7/4/2019 16:53:00 5.1 5.0 40.7 39.9 - - 80 0 323
7/4/2019 16:54:00 5.1 5.0 40.6 39.9 - - 80 0 325
7/4/2019 16:55:00 5.1 5.0 40.6 39.9 - - 80 0 327
7/4/2019 16:56:00 5.1 5.0 40.6 39.8 - - 80 0 328
7/4/2019 16:57:00 5.1 5.0 40.5 39.8 - - 80 0 330
7/4/2019 16:58:00 5.1 5.0 40.5 39.7 - - 80 0 332
7/4/2019 16:59:00 5.1 5.0 40.4 39.7 - - 80 0 334
7/4/2019 17:00:00 5.2 5.0 40.4 39.6 - - 80 0 336
7/4/2019 17:01:00 5.1 5.0 40.4 39.6 - - 80 0 338
7/4/2019 17:01:40 Alarm: CLOSE - Heater failure.
7/4/2019 17:02:00 5.1 5.0 40.3 39.6 - - 80 0 340
7/4/2019 17:03:00 5.1 5.0 40.3 39.5 - - 80 0 342
7/4/2019 17:04:00 5.1 5.0 40.2 39.5 - - 80 0 344
7/4/2019 17:05:00 5.2 5.0 40.2 39.4 - - 80 0 346
7/4/2019 17:06:00 5.1 5.0 40.2 39.4 - - 80 0 348
7/4/2019 17:07:00 5.1 5.0 40.1 39.4 - - 80 0 350

-------------------------------------------
Approved by Date Page: 5 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/4/2019 17:08:00 5.1 5.0 40.1 39.3 - - 80 0 352
7/4/2019 17:09:00 5.2 5.0 40.1 39.3 - - 80 0 354
7/4/2019 17:10:00 5.1 5.0 40.0 39.2 - - 80 0 356
7/4/2019 17:11:00 5.1 5.0 40.0 39.2 - - 80 0 358
7/4/2019 17:12:00 5.1 5.0 39.9 39.2 - - 80 0 360
7/4/2019 17:13:00 5.1 5.0 39.9 39.2 - - 80 0 363
7/4/2019 17:14:00 5.1 5.0 39.9 39.1 - - 80 0 365
7/4/2019 17:15:00 5.1 5.0 39.9 39.1 - - 80 0 367
7/4/2019 17:16:00 5.1 5.0 39.8 39.0 - - 80 0 369
7/4/2019 17:17:00 5.1 5.0 39.8 39.0 - - 80 0 372
7/4/2019 17:18:00 5.1 5.0 39.8 38.9 - - 80 0 374
7/4/2019 17:19:00 5.1 5.0 39.7 38.9 - - 80 0 376
7/4/2019 17:20:00 5.1 5.0 39.6 38.9 - - 80 0 378
7/4/2019 17:21:00 5.1 5.0 39.6 38.8 - - 80 0 380
7/4/2019 17:22:00 5.1 5.0 39.6 38.8 - - 80 0 382
7/4/2019 17:23:00 5.2 5.0 39.5 38.8 - - 80 0 384
7/4/2019 17:24:00 5.1 5.0 39.5 38.7 - - 80 0 384
7/4/2019 17:25:00 5.1 5.0 39.5 38.7 - - 80 0 387
7/4/2019 17:26:00 5.2 5.0 39.4 38.6 - - 80 0 389
7/4/2019 17:27:00 5.1 5.0 39.4 38.6 - - 80 0 392
7/4/2019 17:28:00 5.1 5.0 39.4 38.5 - - 80 0 394
7/4/2019 17:29:00 5.1 5.0 39.3 38.5 - - 80 0 396
7/4/2019 17:30:00 5.1 5.0 39.3 38.5 - - 80 0 398
7/4/2019 17:31:00 5.1 5.0 39.3 38.5 - - 80 0 400
7/4/2019 17:32:00 5.1 5.0 39.2 38.4 - - 80 0 403
7/4/2019 17:33:00 5.1 5.0 39.2 38.4 - - 80 0 406
7/4/2019 17:34:00 5.1 5.0 39.1 38.3 - - 80 0 405

-------------------------------------------
Approved by Date Page: 6 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/4/2019 17:35:00 5.1 5.0 39.1 38.3 - - 80 0 408
7/4/2019 17:36:00 5.1 5.0 39.0 38.2 - - 80 0 410
7/4/2019 17:37:00 5.1 5.0 39.0 38.2 - - 80 0 412
7/4/2019 17:38:00 5.2 5.0 39.0 38.2 - - 80 0 415
7/4/2019 17:39:00 5.1 5.0 39.0 38.1 - - 80 0 417
7/4/2019 17:40:00 5.2 5.0 38.9 38.1 - - 80 0 420
7/4/2019 17:41:00 5.1 5.0 38.9 38.0 - - 80 0 422
7/4/2019 17:42:00 5.1 5.0 38.8 38.0 - - 80 0 422
7/4/2019 17:43:00 5.1 5.0 38.8 38.0 - - 80 0 425
7/4/2019 17:44:00 5.1 5.0 38.7 37.9 - - 80 0 427
7/4/2019 17:45:00 5.2 5.0 38.7 37.9 - - 80 0 430
7/4/2019 17:46:00 5.2 5.0 38.7 37.9 - - 80 0 432
7/4/2019 17:47:00 5.1 5.0 38.7 37.9 - - 80 0 435
7/4/2019 17:48:00 5.1 5.0 38.6 37.8 - - 80 0 435
7/4/2019 17:49:00 5.1 5.0 38.6 37.8 - - 80 0 437
7/4/2019 17:50:00 5.1 5.0 38.5 37.7 - - 80 0 440
7/4/2019 17:51:00 5.2 5.0 38.5 37.7 - - 80 0 442
7/4/2019 17:52:00 5.1 5.0 38.5 37.7 - - 80 0 445
7/4/2019 17:53:00 5.1 5.0 38.4 37.6 - - 80 0 445
7/4/2019 17:54:00 5.1 5.0 38.4 37.6 - - 80 0 447
7/4/2019 17:55:00 5.1 5.0 38.4 37.6 - - 80 0 450
7/4/2019 17:56:00 5.1 5.0 38.3 37.5 - - 80 0 453
7/4/2019 17:57:00 5.1 5.0 38.3 37.5 - - 80 0 455
7/4/2019 17:58:00 5.2 5.0 38.2 37.4 - - 80 0 455
7/4/2019 17:59:00 5.1 5.0 38.2 37.4 - - 80 0 458
7/4/2019 18:00:00 5.1 5.0 38.2 37.4 - - 80 0 461
7/4/2019 18:01:00 5.1 5.0 38.1 37.3 - - 80 0 463

-------------------------------------------
Approved by Date Page: 7 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/4/2019 18:02:00 5.1 5.0 38.1 37.3 - - 80 0 466
7/4/2019 18:03:00 5.1 5.0 38.0 37.3 - - 80 0 468
7/4/2019 18:04:00 5.2 5.0 38.0 37.2 - - 80 0 468
7/4/2019 18:05:00 5.1 5.0 38.0 37.2 - - 80 0 471
7/4/2019 18:06:00 5.2 5.0 38.0 37.2 - - 80 0 474
7/4/2019 18:07:00 5.1 5.0 37.9 37.1 - - 80 0 474
7/4/2019 18:08:00 5.1 5.0 37.9 37.1 - - 80 0 477
7/4/2019 18:09:00 5.1 5.0 37.8 37.0 - - 80 0 480
7/4/2019 18:10:00 5.1 5.0 37.8 37.0 - - 80 0 483
7/4/2019 18:11:00 5.1 5.0 37.8 37.0 - - 80 0 485
7/4/2019 18:12:00 5.1 5.0 37.7 36.9 - - 80 0 485
7/4/2019 18:13:00 5.1 5.0 37.7 36.9 - - 80 0 488
7/4/2019 18:14:00 5.1 5.0 37.7 36.9 - - 80 0 491
7/4/2019 18:15:00 5.1 5.0 37.6 36.8 - - 80 0 491
7/4/2019 18:16:00 5.1 5.0 37.6 36.8 - - 80 0 494
7/4/2019 18:17:00 5.1 5.0 37.6 36.8 - - 80 0 496
7/4/2019 18:18:00 5.1 5.0 37.5 36.7 - - 80 0 499
7/4/2019 18:19:00 5.1 5.0 37.5 36.7 - - 80 0 499
7/4/2019 18:20:00 5.2 5.0 37.5 36.7 - - 80 0 502
7/4/2019 18:21:00 5.1 5.0 37.4 36.6 - - 80 0 505
7/4/2019 18:22:00 5.1 5.0 37.4 36.6 - - 80 0 505
7/4/2019 18:23:00 5.1 5.0 37.3 36.6 - - 80 0 508
7/4/2019 18:24:00 5.1 5.0 37.3 36.5 - - 80 0 511
7/4/2019 18:25:00 5.1 5.0 37.2 36.5 - - 80 0 514
7/4/2019 18:26:00 5.1 5.0 37.2 36.5 - - 80 0 514
7/4/2019 18:27:00 5.1 5.0 37.2 36.4 - - 80 0 518
7/4/2019 18:28:00 5.2 5.0 37.2 36.4 - - 80 0 521

-------------------------------------------
Approved by Date Page: 8 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/4/2019 18:29:00 5.1 5.0 37.1 36.3 - - 80 0 524
7/4/2019 18:30:00 5.1 5.0 37.1 36.3 - - 80 0 524
7/4/2019 18:31:00 5.1 5.0 37.1 36.3 - - 80 0 527
7/4/2019 18:32:00 5.1 5.0 37.0 36.2 - - 80 0 527
7/4/2019 18:33:00 5.1 5.0 37.0 36.2 - - 80 0 529
7/4/2019 18:34:00 5.1 5.0 37.0 36.2 - - 80 0 533
7/4/2019 18:35:00 5.1 5.0 36.9 36.1 - - 80 0 536
7/4/2019 18:36:00 5.1 5.0 36.9 36.1 - - 80 0 536
7/4/2019 18:37:00 5.1 5.0 36.8 36.0 - - 80 0 539
7/4/2019 18:38:00 5.1 5.0 36.8 36.0 - - 80 0 542
7/4/2019 18:39:00 5.1 5.0 36.8 36.0 - - 80 0 542
7/4/2019 18:40:00 5.2 5.0 36.7 36.0 - - 80 0 545
7/4/2019 18:41:00 5.2 5.0 36.7 36.0 - - 80 0 548
7/4/2019 18:42:00 5.2 5.0 36.6 35.9 - - 80 0 548
7/4/2019 18:43:00 5.1 5.0 36.6 35.8 - - 80 0 551
7/4/2019 18:44:00 5.1 5.0 36.6 35.8 - - 80 0 555
7/4/2019 18:45:00 5.1 5.0 36.6 35.8 - - 80 0 555
7/4/2019 18:46:00 5.1 5.0 36.6 35.8 - - 80 0 558
7/4/2019 18:47:00 5.2 5.0 36.5 35.8 - - 80 0 561
7/4/2019 18:48:00 5.1 5.0 36.4 35.7 - - 80 0 561
7/4/2019 18:49:00 5.2 5.0 36.4 35.7 - - 80 0 564
7/4/2019 18:50:00 5.1 5.0 36.4 35.6 - - 80 0 568
7/4/2019 18:51:00 5.1 5.0 36.4 35.6 - - 80 0 568
7/4/2019 18:52:00 5.1 5.0 36.3 35.5 - - 80 0 571
7/4/2019 18:53:00 5.1 5.0 36.3 35.5 - - 80 0 574
7/4/2019 18:54:00 5.2 5.0 36.2 35.5 - - 80 0 574
7/4/2019 18:55:00 5.1 5.0 36.2 35.4 - - 80 0 578

-------------------------------------------
Approved by Date Page: 9 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/4/2019 18:56:00 5.1 5.0 36.2 35.4 - - 80 0 581
7/4/2019 18:57:00 5.2 5.0 36.1 35.3 - - 80 0 581
7/4/2019 18:58:00 5.1 5.0 36.1 35.3 - - 80 0 584
7/4/2019 18:59:00 5.1 5.0 36.1 35.3 - - 80 0 584
7/4/2019 19:00:00 5.1 5.0 36.0 35.3 - - 80 0 588
7/4/2019 19:01:00 5.1 5.0 36.0 35.2 - - 80 0 591
7/4/2019 19:02:00 5.1 5.0 36.0 35.2 - - 80 0 591
7/4/2019 19:03:00 5.1 5.0 36.0 35.2 - - 80 0 595
7/4/2019 19:04:00 5.2 5.0 35.9 35.2 - - 80 0 598
7/4/2019 19:05:00 5.1 5.0 35.9 35.1 - - 80 0 598
7/4/2019 19:06:00 5.1 5.0 35.9 35.1 - - 80 0 602
7/4/2019 19:07:00 5.1 5.0 35.8 35.0 - - 80 0 602
7/4/2019 19:08:00 5.1 5.0 35.8 35.0 - - 80 0 605
7/4/2019 19:09:00 5.1 5.0 35.7 35.0 - - 80 0 608
7/4/2019 19:10:00 5.1 5.0 35.7 34.9 - - 80 0 608
7/4/2019 19:11:00 5.2 5.0 35.7 34.9 - - 80 0 612
7/4/2019 19:12:00 5.1 5.0 35.6 34.9 - - 80 0 612
7/4/2019 19:13:00 5.1 5.0 35.6 34.8 - - 80 0 615
7/4/2019 19:14:00 5.1 5.0 35.6 34.8 - - 80 0 619
7/4/2019 19:15:00 5.1 5.0 35.5 34.8 - - 80 0 619
7/4/2019 19:16:00 5.1 5.0 35.5 34.7 - - 80 0 623
7/4/2019 19:17:00 5.1 5.0 35.5 34.7 - - 80 0 626
7/4/2019 19:18:00 5.1 5.0 35.5 34.7 - - 80 0 626
7/4/2019 19:19:00 5.1 5.0 35.4 34.7 - - 80 0 630
7/4/2019 19:20:00 5.1 5.0 35.4 34.6 - - 80 0 630
7/4/2019 19:21:00 5.1 5.0 35.3 34.6 - - 80 0 634
7/4/2019 19:22:00 5.1 5.0 35.3 34.6 - - 80 0 634

-------------------------------------------
Approved by Date Page: 10 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/4/2019 19:23:00 5.1 5.0 35.3 34.5 - - 80 0 637
7/4/2019 19:24:00 5.2 5.0 35.2 34.5 - - 80 0 641
7/4/2019 19:25:00 5.1 5.0 35.2 34.4 - - 80 0 641
7/4/2019 19:26:00 5.1 5.0 35.2 34.4 - - 80 0 645
7/4/2019 19:27:00 5.1 5.0 35.2 34.4 - - 80 0 645
7/4/2019 19:28:00 5.1 5.0 35.1 34.4 - - 80 0 649
7/4/2019 19:29:00 5.1 5.0 35.1 34.3 - - 80 0 652
7/4/2019 19:30:00 5.2 5.0 35.0 34.3 - - 80 0 653
7/4/2019 19:31:00 5.2 5.0 35.0 34.2 - - 80 0 656
7/4/2019 19:32:00 5.1 5.0 35.0 34.2 - - 80 0 656
7/4/2019 19:33:00 5.1 5.0 35.0 34.2 - - 80 0 660
7/4/2019 19:34:00 5.1 5.0 35.0 34.2 - - 80 0 660
7/4/2019 19:35:00 5.1 5.0 34.9 34.1 - - 80 0 664
7/4/2019 19:36:00 5.1 5.0 34.8 34.1 - - 80 0 668
7/4/2019 19:37:00 5.1 5.0 34.8 34.0 - - 80 0 668
7/4/2019 19:38:00 5.1 5.0 34.8 34.0 - - 80 0 672
7/4/2019 19:39:00 5.0 5.0 34.7 34.0 - - 80 0 672
7/4/2019 19:40:00 5.1 5.0 34.7 34.0 - - 80 0 676
7/4/2019 19:41:00 5.2 5.0 34.7 33.9 - - 80 0 676
7/4/2019 19:42:00 5.1 5.0 34.6 33.8 - - 80 0 680
7/4/2019 19:43:00 5.2 5.0 34.6 33.9 - - 80 0 680
7/4/2019 19:44:00 5.2 5.0 34.6 33.8 - - 80 0 684
7/4/2019 19:45:00 5.2 5.0 34.5 33.8 - - 80 0 688
7/4/2019 19:46:00 5.1 5.0 34.5 33.8 - - 80 0 688
7/4/2019 19:47:00 5.1 5.0 34.5 33.7 - - 80 0 692
7/4/2019 19:48:00 5.1 5.0 34.4 33.7 - - 80 0 692
7/4/2019 19:49:00 5.1 5.0 34.4 33.7 - - 80 0 696

-------------------------------------------
Approved by Date Page: 11 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/4/2019 19:50:00 5.2 5.0 34.4 33.7 - - 80 0 696
7/4/2019 19:51:00 5.1 5.0 34.3 33.6 - - 80 0 700
7/4/2019 19:52:00 5.1 5.0 34.3 33.6 - - 80 0 700
7/4/2019 19:53:00 5.2 5.0 34.3 33.6 - - 80 0 704
7/4/2019 19:54:00 5.1 5.0 34.2 33.5 - - 80 0 704
7/4/2019 19:55:00 5.1 5.0 34.2 33.5 - - 80 0 708
7/4/2019 19:56:00 5.1 5.0 34.2 33.4 - - 80 0 708
7/4/2019 19:57:00 5.1 5.0 34.1 33.4 - - 80 0 712
7/4/2019 19:58:00 5.1 5.0 34.1 33.4 - - 80 0 716
7/4/2019 19:59:00 5.1 5.0 34.0 33.3 - - 80 0 716
7/4/2019 20:00:00 5.2 5.0 34.0 33.3 - - 80 0 721
7/4/2019 20:01:00 5.1 5.0 34.0 33.3 - - 80 0 721
7/4/2019 20:02:00 5.1 5.0 34.0 33.3 - - 80 0 725
7/4/2019 20:03:00 5.1 5.0 33.9 33.2 - - 80 0 725
7/4/2019 20:04:00 5.1 5.0 33.9 33.2 - - 80 0 729
7/4/2019 20:05:00 5.1 5.0 33.9 33.2 - - 80 0 729
7/4/2019 20:06:00 5.1 5.0 33.8 33.1 - - 80 0 734
7/4/2019 20:07:00 5.1 5.0 33.8 33.1 - - 80 0 734
7/4/2019 20:08:00 5.2 5.0 33.8 33.1 - - 80 0 738
7/4/2019 20:09:00 5.2 5.0 33.7 33.0 - - 80 0 738
7/4/2019 20:10:00 5.1 5.0 33.7 33.0 - - 80 0 742
7/4/2019 20:11:00 5.1 5.0 33.7 33.0 - - 80 0 742
7/4/2019 20:12:00 5.1 5.0 33.6 33.0 - - 80 0 747
7/4/2019 20:13:00 5.1 5.0 33.6 32.9 - - 80 0 747
7/4/2019 20:14:00 5.1 5.0 33.6 32.9 - - 80 0 751
7/4/2019 20:15:00 5.1 5.0 33.6 32.8 - - 80 0 751
7/4/2019 20:16:00 5.1 5.0 33.5 32.8 - - 80 0 755

-------------------------------------------
Approved by Date Page: 12 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/4/2019 20:17:00 5.1 5.0 33.5 32.8 - - 80 0 755
7/4/2019 20:18:00 5.2 5.0 33.5 32.8 - - 80 0 760
7/4/2019 20:19:00 5.2 5.0 33.4 32.7 - - 80 0 760
7/4/2019 20:20:00 5.1 5.0 33.4 32.7 - - 80 0 764
7/4/2019 20:20:07 Audit: - Slave panel is enabled by IDIN.
7/4/2019 20:20:14 Audit: - A_HTRFAIL ALARM is acknowledged by IDIN.
7/4/2019 20:21:00 5.1 5.0 33.4 32.7 - - 80 0 764
7/4/2019 20:22:00 5.1 5.0 33.3 32.7 - - 80 0 769
7/4/2019 20:23:00 5.1 5.0 33.3 32.6 - - 80 0 769
7/4/2019 20:24:00 5.1 5.0 33.2 32.6 - - 80 0 772
7/4/2019 20:25:00 5.1 5.0 33.2 32.5 - - 80 0 773
7/4/2019 20:26:00 5.1 5.0 33.2 32.5 - - 80 0 777
7/4/2019 20:27:00 5.1 5.0 33.2 32.5 - - 80 0 778
7/4/2019 20:28:00 5.1 5.0 33.1 32.5 - - 80 0 782
7/4/2019 20:29:00 5.0 5.0 33.1 32.4 - - 80 0 782
7/4/2019 20:30:00 5.0 5.0 33.1 32.4 - - 80 0 787
7/4/2019 20:31:00 5.1 5.0 33.1 32.4 - - 80 0 787
7/4/2019 20:32:00 5.1 5.0 33.0 32.3 - - 80 0 787
7/4/2019 20:33:00 5.2 5.0 33.0 32.3 - - 80 0 791
7/4/2019 20:34:00 5.0 5.0 33.0 32.3 - - 80 0 796
7/4/2019 20:35:00 5.1 5.0 32.9 32.2 - - 80 0 796
7/4/2019 20:36:00 5.1 5.0 32.9 32.2 - - 80 0 801
7/4/2019 20:37:00 5.1 5.0 32.8 32.2 - - 80 0 800
7/4/2019 20:38:00 5.0 5.0 32.8 32.2 - - 80 0 805
7/4/2019 20:39:00 5.0 5.0 32.8 32.1 - - 80 0 805
7/4/2019 20:40:00 5.1 5.0 32.8 32.1 - - 80 0 809
7/4/2019 20:41:00 5.2 5.0 32.7 32.1 - - 80 0 810

-------------------------------------------
Approved by Date Page: 13 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/4/2019 20:42:00 5.1 5.0 32.7 32.0 - - 80 0 809
7/4/2019 20:43:00 5.1 5.0 32.7 32.0 - - 80 0 814
7/4/2019 20:44:00 5.1 5.0 32.6 32.0 - - 80 0 815
7/4/2019 20:45:00 5.1 5.0 32.6 32.0 - - 80 0 820
7/4/2019 20:46:00 5.1 5.0 32.6 31.9 - - 80 0 820
7/4/2019 20:47:00 5.1 5.0 32.5 31.9 - - 80 0 824
7/4/2019 20:48:00 5.1 5.0 32.5 31.9 - - 80 0 824
7/4/2019 20:49:00 5.1 5.0 32.5 31.8 - - 80 0 829
7/4/2019 20:50:00 5.1 5.0 32.5 31.8 - - 80 0 829
7/4/2019 20:51:00 5.1 5.0 32.4 31.8 - - 80 0 833
7/4/2019 20:52:00 5.1 5.0 32.4 31.7 - - 80 0 834
7/4/2019 20:53:00 5.1 5.0 32.4 31.7 - - 80 0 838
7/4/2019 20:54:00 5.1 5.0 32.3 31.7 - - 80 0 838
7/4/2019 20:55:00 5.1 5.0 32.3 31.6 - - 80 0 839
7/4/2019 20:56:00 5.1 5.0 32.2 31.6 - - 80 0 844
7/4/2019 20:57:00 5.1 5.0 32.2 31.6 - - 80 0 843
7/4/2019 20:58:00 5.1 5.0 32.2 31.6 - - 80 0 848
7/4/2019 20:59:00 5.1 5.0 32.2 31.5 - - 80 0 848
7/4/2019 21:00:00 5.1 5.0 32.2 31.5 - - 80 0 853
7/4/2019 21:01:00 5.1 5.0 32.1 31.5 - - 80 0 853
7/4/2019 21:02:00 5.1 5.0 32.1 31.4 - - 80 0 853
7/4/2019 21:03:00 5.2 5.0 32.0 31.4 - - 80 0 858
7/4/2019 21:04:00 5.1 5.0 32.0 31.4 - - 80 0 858
7/4/2019 21:05:00 5.1 5.0 32.0 31.4 - - 80 0 863
7/4/2019 21:06:00 5.0 5.0 32.0 31.3 - - 80 0 864
7/4/2019 21:07:00 5.0 5.0 32.0 31.3 - - 80 0 868
7/4/2019 21:08:00 5.1 5.0 31.9 31.3 - - 80 0 868

-------------------------------------------
Approved by Date Page: 14 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/4/2019 21:09:00 5.2 5.0 31.8 31.2 - - 80 0 873
7/4/2019 21:10:00 5.2 5.0 31.9 31.2 - - 80 0 873
7/4/2019 21:11:00 5.1 5.0 31.8 31.2 - - 80 0 873
7/4/2019 21:12:00 5.1 5.0 31.8 31.2 - - 80 0 878
7/4/2019 21:13:00 5.1 5.0 31.7 31.1 - - 80 0 878
7/4/2019 21:14:00 5.2 5.0 31.7 31.2 - - 80 0 883
7/4/2019 21:15:00 5.1 5.0 31.7 31.1 - - 80 0 883
7/4/2019 21:16:00 5.1 5.0 31.7 31.1 - - 80 0 889
7/4/2019 21:17:00 5.1 5.0 31.6 31.0 - - 80 0 889
7/4/2019 21:18:00 5.1 5.0 31.6 31.0 - - 80 0 889
7/4/2019 21:19:00 5.0 5.0 31.6 31.0 - - 80 0 894
7/4/2019 21:20:00 5.1 5.0 31.5 31.0 - - 80 0 894
7/4/2019 21:21:00 5.1 5.0 31.5 30.9 - - 80 0 899
7/4/2019 21:22:00 5.1 5.0 31.5 30.9 - - 80 0 899
7/4/2019 21:23:00 5.1 5.0 31.4 30.8 - - 80 0 904
7/4/2019 21:24:00 5.1 5.0 31.4 30.8 - - 80 0 904
7/4/2019 21:25:00 5.0 5.0 31.4 30.8 - - 80 0 904
7/4/2019 21:26:00 5.1 5.0 31.4 30.8 - - 80 0 910
7/4/2019 21:27:00 5.1 5.0 31.3 30.8 - - 80 0 910
7/4/2019 21:28:00 5.1 5.0 31.3 30.7 - - 80 0 910
7/4/2019 21:29:00 5.1 5.0 31.2 30.6 - - 80 0 914
7/4/2019 21:30:00 5.1 5.0 31.2 30.6 - - 80 0 915
7/4/2019 21:31:00 5.1 5.0 31.2 30.6 - - 80 0 920
7/4/2019 21:32:00 5.1 5.0 31.2 30.6 - - 80 0 920
7/4/2019 21:33:00 5.1 5.0 31.2 30.6 - - 80 0 925
7/4/2019 21:34:00 5.1 5.0 31.1 30.6 - - 80 0 926
7/4/2019 21:35:00 5.1 5.0 31.1 30.5 - - 80 0 926

-------------------------------------------
Approved by Date Page: 15 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/4/2019 21:36:00 5.1 5.0 31.1 30.5 - - 80 0 931
7/4/2019 21:37:00 5.1 5.0 31.0 30.5 - - 80 0 931
7/4/2019 21:38:00 5.1 5.0 31.0 30.5 - - 80 0 936
7/4/2019 21:39:00 5.1 5.0 31.0 30.4 - - 80 0 936
7/4/2019 21:40:00 5.1 5.0 30.9 30.4 - - 80 0 942
7/4/2019 21:41:00 5.1 5.0 30.9 30.4 - - 80 0 942
7/4/2019 21:42:00 5.1 5.0 30.9 30.3 - - 80 0 942
7/4/2019 21:43:00 5.1 5.0 30.8 30.3 - - 80 0 947
7/4/2019 21:44:00 5.1 5.0 30.8 30.3 - - 80 0 947
7/4/2019 21:45:00 5.1 5.0 30.8 30.2 - - 80 0 947
7/4/2019 21:46:00 5.1 5.0 30.8 30.2 - - 80 0 953
7/4/2019 21:47:00 5.1 5.0 30.8 30.2 - - 80 0 953
7/4/2019 21:48:00 5.1 5.0 30.7 30.2 - - 80 0 959
7/4/2019 21:49:00 5.1 5.0 30.7 30.2 - - 80 0 959
7/4/2019 21:50:00 5.1 5.0 30.6 30.1 - - 80 0 958
7/4/2019 21:51:00 5.1 5.0 30.6 30.1 - - 80 0 964
7/4/2019 21:52:00 5.1 5.0 30.6 30.1 - - 80 0 964
7/4/2019 21:53:00 5.2 5.0 30.6 30.0 - - 80 0 970
7/4/2019 21:54:00 5.1 5.0 30.6 30.0 - - 80 0 970
7/4/2019 21:55:00 5.2 5.0 30.5 30.0 - - 80 0 969
7/4/2019 21:56:00 5.1 5.0 30.5 30.0 - - 80 0 975
7/4/2019 21:57:00 5.2 5.0 30.5 29.9 - - 80 0 975
7/4/2019 21:58:00 5.1 5.0 30.4 29.9 - - 80 0 975
7/4/2019 21:59:00 5.0 5.0 30.4 29.9 - - 80 0 980
7/4/2019 22:00:00 5.1 5.0 30.4 29.9 - - 80 0 981
7/4/2019 22:01:00 5.1 5.0 30.4 29.8 - - 80 0 986
7/4/2019 22:02:00 5.1 5.0 30.3 29.8 - - 80 0 987

-------------------------------------------
Approved by Date Page: 16 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/4/2019 22:03:00 5.1 5.0 30.3 29.8 - - 80 0 987
7/4/2019 22:03:17 Alarm: CLOSE - Heater failure.
7/4/2019 22:04:00 5.1 5.0 30.3 29.8 - - 80 0 992
7/4/2019 22:05:00 5.2 5.0 30.3 29.8 - - 80 0 992
7/4/2019 22:06:00 5.1 5.0 30.2 29.7 - - 80 0 998
7/4/2019 22:06:58 Alarm: CLOSE - Heater failure.
7/4/2019 22:07:00 5.1 5.0 30.2 29.7 - - 80 0 998
7/4/2019 22:08:00 5.0 5.0 30.1 29.7 - - 80 0 998
7/4/2019 22:08:38 Alarm: CLOSE - Heater failure.
7/4/2019 22:08:51 Alarm: CLOSE - Heater failure.
7/4/2019 22:09:00 5.1 5.0 30.1 29.6 - - 80 0 -
7/4/2019 22:09:39 Alarm: CLOSE - Heater failure.
7/4/2019 22:09:58 Alarm: CLOSE - Heater failure.
7/4/2019 22:10:00 5.1 5.0 30.1 29.6 - - 80 0 -
7/4/2019 22:11:00 5.1 5.0 30.1 29.6 - - 80 0 -
7/4/2019 22:11:59 Alarm: CLOSE - Heater failure.
7/4/2019 22:12:00 5.2 5.0 30.1 29.5 - - 80 0 -
7/4/2019 22:12:39 Alarm: CLOSE - Heater failure.
7/4/2019 22:12:47 Alarm: CLOSE - Heater failure.
7/4/2019 22:13:00 5.1 5.0 30.1 29.5 - - 80 0 -
7/4/2019 22:14:00 5.2 5.0 30.0 29.5 - - 80 0 -
7/4/2019 22:14:59 Alarm: CLOSE - Heater failure.
7/4/2019 22:15:00 5.2 5.0 30.0 29.5 - - 80 0 -
7/4/2019 22:16:00 5.1 5.0 30.0 29.4 - - 80 0 -
7/4/2019 22:16:38 Alarm: CLOSE - Heater failure.
7/4/2019 22:17:00 5.0 5.0 29.9 29.4 - - 80 0 -
7/4/2019 22:18:00 5.1 5.0 29.9 29.4 - - 80 0 -

-------------------------------------------
Approved by Date Page: 17 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/4/2019 22:19:00 5.1 5.0 29.9 29.3 - - 80 0 -
7/4/2019 22:20:00 5.1 5.0 29.8 29.3 - - 80 0 -
7/4/2019 22:21:00 5.2 5.0 29.8 29.3 - - 80 0 -
7/4/2019 22:22:00 5.2 5.0 29.8 29.3 - - 80 0 -
7/4/2019 22:23:00 5.2 5.0 29.7 29.2 - - 80 0 -
7/4/2019 22:24:00 5.2 5.0 29.7 29.2 - - 80 0 -
7/4/2019 22:25:00 5.1 5.0 29.7 29.2 - - 80 0 -
7/4/2019 22:26:00 5.1 5.0 29.7 29.2 - - 80 0 -
7/4/2019 22:27:00 5.0 5.0 29.6 29.1 - - 80 0 -
7/4/2019 22:28:00 5.1 5.0 29.6 29.2 - - 80 0 -
7/4/2019 22:29:00 5.1 5.0 29.6 29.1 - - 80 0 -
7/4/2019 22:30:00 5.1 5.0 29.5 29.1 - - 80 0 -
7/4/2019 22:31:00 5.1 5.0 29.5 29.1 - - 80 0 -
7/4/2019 22:32:00 5.2 5.0 29.5 29.0 - - 80 0 -
7/4/2019 22:33:00 5.1 5.0 29.5 29.0 - - 80 0 -
7/4/2019 22:34:00 5.1 5.0 29.5 29.0 - - 80 0 -
7/4/2019 22:35:00 5.1 5.0 29.4 28.9 - - 80 0 -
7/4/2019 22:36:00 5.1 5.0 29.4 29.0 - - 80 0 -
7/4/2019 22:37:00 5.1 5.0 29.4 28.9 - - 80 0 -
7/4/2019 22:38:00 5.1 5.0 29.4 28.9 - - 80 0 -
7/4/2019 22:39:00 5.1 5.0 29.3 28.9 - - 80 0 -
7/4/2019 22:40:00 5.1 5.0 29.3 28.8 - - 80 0 -
7/4/2019 22:41:00 5.1 5.0 29.2 28.8 - - 80 0 -
7/4/2019 22:42:00 5.1 5.0 29.2 28.8 - - 80 0 -
7/4/2019 22:43:00 5.1 5.0 29.2 28.8 - - 80 0 -
7/4/2019 22:44:00 5.1 5.0 29.2 28.7 - - 80 0 -
7/4/2019 22:45:00 5.1 5.0 29.1 28.7 - - 80 0 -

-------------------------------------------
Approved by Date Page: 18 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/4/2019 22:46:00 5.1 5.0 29.1 28.7 - - 80 0 -
7/4/2019 22:47:00 5.1 5.0 29.1 28.7 - - 80 0 -
7/4/2019 22:48:00 5.1 5.0 29.1 28.6 - - 80 0 -
7/4/2019 22:49:00 5.1 5.0 29.0 28.6 - - 80 0 -
7/4/2019 22:50:00 5.2 5.0 29.0 28.6 - - 80 0 -
7/4/2019 22:51:00 5.1 5.0 29.0 28.5 - - 80 0 -
7/4/2019 22:52:00 5.1 5.0 29.0 28.5 - - 80 0 -
7/4/2019 22:53:00 5.1 5.0 28.9 28.5 - - 80 0 -
7/4/2019 22:54:00 5.1 5.0 28.9 28.5 - - 80 0 -
7/4/2019 22:55:00 5.2 5.0 28.9 28.5 - - 80 0 -
7/4/2019 22:56:00 5.1 5.0 28.9 28.4 - - 80 0 -
7/4/2019 22:57:00 5.1 5.0 28.9 28.4 - - 80 0 -
7/4/2019 22:58:00 5.1 5.0 28.8 28.4 - - 80 0 -
7/4/2019 22:59:00 5.1 5.0 28.8 28.4 - - 80 0 -
7/4/2019 23:00:00 5.1 5.0 28.8 28.3 - - 80 0 -
7/4/2019 23:01:00 5.1 5.0 28.7 28.3 - - 80 0 -
7/4/2019 23:02:00 5.1 5.0 28.7 28.3 - - 80 0 -
7/4/2019 23:03:00 5.0 5.0 28.7 28.3 - - 80 0 -
7/4/2019 23:04:00 5.1 5.0 28.7 28.2 - - 80 0 -
7/4/2019 23:05:00 5.2 5.0 28.6 28.2 - - 80 0 -
7/4/2019 23:06:00 5.1 5.0 28.6 28.2 - - 80 0 -
7/4/2019 23:07:00 5.2 5.0 28.6 28.2 - - 80 0 -
7/4/2019 23:08:00 5.1 5.0 28.5 28.1 - - 80 0 -
7/4/2019 23:09:00 5.0 5.0 28.5 28.1 - - 80 0 -
7/4/2019 23:10:00 5.1 5.0 28.5 28.1 - - 80 0 -
7/4/2019 23:11:00 5.1 5.0 28.5 28.1 - - 80 0 -
7/4/2019 23:12:00 5.1 5.0 28.5 28.1 - - 80 0 -

-------------------------------------------
Approved by Date Page: 19 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/4/2019 23:13:00 5.2 5.0 28.4 28.0 - - 80 0 -
7/4/2019 23:14:00 5.1 5.0 28.4 27.9 - - 80 0 -
7/4/2019 23:15:00 5.2 5.0 28.4 28.0 - - 80 0 -
7/4/2019 23:16:00 5.1 5.0 28.4 27.9 - - 80 0 -
7/4/2019 23:17:00 5.1 5.0 28.3 27.9 - - 80 0 -
7/4/2019 23:18:00 5.0 5.0 28.3 27.9 - - 80 0 -
7/4/2019 23:19:00 5.1 5.0 28.3 27.9 - - 80 0 -
7/4/2019 23:20:00 5.1 5.0 28.3 27.8 - - 80 0 -
7/4/2019 23:21:00 5.1 5.0 28.3 27.8 - - 80 0 -
7/4/2019 23:22:00 5.2 5.0 28.2 27.8 - - 80 0 -
7/4/2019 23:23:00 5.2 5.0 28.2 27.8 - - 80 0 -
7/4/2019 23:24:00 5.2 5.0 28.2 27.7 - - 80 0 -
7/4/2019 23:25:00 5.1 5.0 28.2 27.7 - - 80 0 -
7/4/2019 23:26:00 5.1 5.0 28.1 27.7 - - 80 0 -
7/4/2019 23:27:00 5.1 5.0 28.1 27.7 - - 80 0 -
7/4/2019 23:28:00 5.1 5.0 28.1 27.6 - - 80 0 -
7/4/2019 23:29:00 5.1 5.0 28.1 27.6 - - 80 0 -
7/4/2019 23:30:00 5.1 5.0 28.0 27.6 - - 80 0 -
7/4/2019 23:31:00 5.1 5.0 28.0 27.6 - - 80 0 -
7/4/2019 23:32:00 5.1 5.0 27.9 27.6 - - 80 0 -
7/4/2019 23:33:00 5.1 5.0 27.9 27.5 - - 80 0 -
7/4/2019 23:34:00 5.2 5.0 27.9 27.5 - - 80 0 -
7/4/2019 23:35:00 5.1 5.0 27.9 27.5 - - 80 0 -
7/4/2019 23:36:00 5.1 5.0 27.9 27.5 - - 80 0 -
7/4/2019 23:37:00 5.1 5.0 27.9 27.4 - - 80 0 -
7/4/2019 23:38:00 5.1 5.0 27.8 27.4 - - 80 0 -
7/4/2019 23:39:00 5.1 5.0 27.8 27.4 - - 80 0 -

-------------------------------------------
Approved by Date Page: 20 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/4/2019 23:40:00 5.1 5.0 27.8 27.4 - - 80 0 -
7/4/2019 23:41:00 5.1 5.0 27.7 27.3 - - 80 0 -
7/4/2019 23:42:00 5.2 5.0 27.7 27.3 - - 80 0 -
7/4/2019 23:43:00 5.2 5.0 27.7 27.3 - - 80 0 -
7/4/2019 23:44:00 5.2 5.0 27.7 27.3 - - 80 0 -
7/4/2019 23:45:00 5.1 5.0 27.6 27.3 - - 80 0 -
7/4/2019 23:46:00 5.0 5.0 27.6 27.2 - - 80 0 -
7/4/2019 23:47:00 5.1 5.0 27.6 27.2 - - 80 0 -
7/4/2019 23:48:00 5.1 5.0 27.6 27.2 - - 80 0 -
7/4/2019 23:49:00 5.1 5.0 27.6 27.1 - - 80 0 -
7/4/2019 23:50:00 5.1 5.0 27.5 27.1 - - 80 0 -
7/4/2019 23:51:00 5.2 5.0 27.5 27.1 - - 80 0 -
7/4/2019 23:52:00 5.1 5.0 27.5 27.1 - - 80 0 -
7/4/2019 23:53:00 5.2 5.0 27.5 27.1 - - 80 0 -
7/4/2019 23:54:00 5.2 5.0 27.5 27.1 - - 80 0 -
7/4/2019 23:55:00 5.1 5.0 27.4 27.1 - - 80 0 -
7/4/2019 23:56:00 5.1 5.0 27.4 27.0 - - 80 0 -
7/4/2019 23:57:00 5.1 5.0 27.3 26.9 - - 80 0 -
7/4/2019 23:58:00 5.1 5.0 27.3 27.0 - - 80 0 -
7/4/2019 23:59:00 5.2 5.0 27.3 26.9 - - 80 0 -
7/5/2019 00:00:00 5.2 5.0 27.3 26.9 - - 80 0 -
7/5/2019 00:01:00 5.2 5.0 27.3 26.9 - - 80 0 -
7/5/2019 00:01:02 Audit: - Security Synchronizer: Beginning security synchronization process by SecuritySyochronizer.
Audit: - Security Synchronizer: Function is not enabled on this node, check license/key by SecuritySyochronizer.
7/5/2019 00:02:00 5.1 5.0 27.2 26.8 - - 80 0 -
7/5/2019 00:03:00 5.2 5.0 27.2 26.9 - - 80 0 -
7/5/2019 00:04:00 5.1 5.0 27.2 26.8 - - 80 0 34

-------------------------------------------
Approved by Date Page: 21 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 00:05:00 5.1 5.0 27.2 26.8 - - 80 0 13
7/5/2019 00:06:00 5.1 5.0 27.1 26.8 - - 80 0 9
7/5/2019 00:07:00 5.1 5.0 27.1 26.7 - - 80 0 8
7/5/2019 00:08:00 5.1 5.0 27.1 26.7 - - 80 0 7
7/5/2019 00:09:00 5.0 5.0 27.1 26.7 - - 80 0 6
7/5/2019 00:10:00 5.1 5.0 27.1 26.7 - - 80 0 6
7/5/2019 00:11:00 5.1 5.0 27.1 26.7 - - 80 0 5
7/5/2019 00:12:00 5.1 5.0 27.0 26.6 - - 80 0 5
7/5/2019 00:13:00 5.1 5.0 27.0 26.6 - - 80 0 5
7/5/2019 00:14:00 5.1 5.0 26.9 26.6 - - 80 0 4
7/5/2019 00:15:00 5.1 5.0 26.9 26.6 - - 80 0 4
7/5/2019 00:16:00 5.1 5.0 26.9 26.5 - - 80 0 4
7/5/2019 00:17:00 5.1 5.0 26.9 26.5 - - 80 0 4
7/5/2019 00:18:00 5.2 5.0 26.9 26.5 - - 80 0 4
7/5/2019 00:19:00 5.1 5.0 26.8 26.5 - - 80 0 4
7/5/2019 00:20:00 5.1 5.0 26.8 26.5 - - 80 0 4
7/5/2019 00:21:00 5.1 5.0 26.8 26.4 - - 80 0 3
7/5/2019 00:22:00 5.1 5.0 26.8 26.4 - - 80 0 3
7/5/2019 00:23:00 5.1 5.0 26.7 26.3 - - 80 0 3
7/5/2019 00:24:00 5.1 5.0 26.7 26.3 - - 80 0 3
7/5/2019 00:25:00 5.2 5.0 26.7 26.3 - - 80 0 3
7/5/2019 00:26:00 5.2 5.0 26.7 26.3 - - 80 0 3
7/5/2019 00:27:00 5.2 5.0 26.7 26.3 - - 80 0 3
7/5/2019 00:28:00 5.1 5.0 26.6 26.3 - - 80 0 3
7/5/2019 00:29:00 5.1 5.0 26.6 26.3 - - 80 0 3
7/5/2019 00:30:00 5.1 5.0 26.6 26.3 - - 80 0 3
7/5/2019 00:31:00 5.1 5.0 26.5 26.2 - - 80 0 3

-------------------------------------------
Approved by Date Page: 22 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 00:32:00 5.2 5.0 26.6 26.3 - - 80 0 3
7/5/2019 00:33:00 5.2 5.0 26.5 26.2 - - 80 0 3
7/5/2019 00:34:00 5.2 5.0 26.5 26.1 - - 80 0 3
7/5/2019 00:35:00 5.2 5.0 26.5 26.1 - - 80 0 3
7/5/2019 00:36:00 5.1 5.0 26.4 26.1 - - 80 0 3
7/5/2019 00:37:00 5.1 5.0 26.4 26.1 - - 80 0 3
7/5/2019 00:38:00 5.1 5.0 26.4 26.1 - - 80 0 3
7/5/2019 00:39:00 5.1 5.0 26.4 26.0 - - 80 0 3
7/5/2019 00:40:00 5.1 5.0 26.3 26.0 - - 80 0 3
7/5/2019 00:41:00 5.1 5.0 26.3 26.0 - - 80 0 3
7/5/2019 00:42:00 5.1 5.0 26.3 25.9 - - 80 0 3
7/5/2019 00:43:00 5.2 5.0 26.3 25.9 - - 80 0 3
7/5/2019 00:44:00 5.2 5.0 26.2 25.9 - - 80 0 3
7/5/2019 00:45:00 5.1 5.0 26.3 25.9 - - 80 0 3
7/5/2019 00:46:00 5.1 5.0 26.2 25.9 - - 80 0 3
7/5/2019 00:47:00 5.1 5.0 26.2 25.8 - - 80 0 3
7/5/2019 00:48:00 5.1 5.0 26.2 25.8 - - 80 0 3
7/5/2019 00:49:00 5.1 5.0 26.1 25.8 - - 80 0 3
7/5/2019 00:50:00 5.1 5.0 26.1 25.8 - - 80 0 3
7/5/2019 00:51:00 5.1 5.0 26.1 25.8 - - 80 0 3
7/5/2019 00:52:00 5.1 5.0 26.1 25.7 - - 80 0 3
7/5/2019 00:53:00 5.1 5.0 26.1 25.7 - - 80 0 2
7/5/2019 00:54:00 5.1 5.0 26.0 25.7 - - 80 0 2
7/5/2019 00:55:00 5.1 5.0 26.0 25.7 - - 80 0 2
7/5/2019 00:56:00 5.1 5.0 26.0 25.7 - - 80 0 2
7/5/2019 00:57:00 5.1 5.0 26.0 25.7 - - 80 0 2
7/5/2019 00:58:00 5.1 5.0 25.9 25.6 - - 80 0 2

-------------------------------------------
Approved by Date Page: 23 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 00:59:00 5.1 5.0 25.9 25.6 - - 80 0 2
7/5/2019 01:00:00 5.1 5.0 25.9 25.6 - - 80 0 2
7/5/2019 01:01:00 5.1 5.0 25.9 25.5 - - 80 0 2
7/5/2019 01:02:00 5.2 5.0 25.9 25.5 - - 80 0 2
7/5/2019 01:03:00 5.2 5.0 25.8 25.5 - - 80 0 2
7/5/2019 01:04:00 5.1 5.0 25.8 25.5 - - 80 0 2
7/5/2019 01:05:00 5.1 5.0 25.7 25.5 - - 80 0 2
7/5/2019 01:06:00 5.1 5.0 25.7 25.5 - - 80 0 2
7/5/2019 01:07:00 5.1 5.0 25.7 25.4 - - 80 0 2
7/5/2019 01:08:00 5.1 5.0 25.7 25.4 - - 80 0 2
7/5/2019 01:09:00 5.1 5.0 25.7 25.3 - - 80 0 2
7/5/2019 01:10:00 5.1 5.0 25.7 25.3 - - 80 0 2
7/5/2019 01:11:00 5.1 5.0 25.6 25.3 - - 80 0 2
7/5/2019 01:12:00 5.1 5.0 25.6 25.3 - - 80 0 2
7/5/2019 01:13:00 5.1 5.0 25.6 25.3 - - 80 0 2
7/5/2019 01:14:00 5.1 5.0 25.6 25.3 - - 80 0 2
7/5/2019 01:15:00 5.1 5.0 25.5 25.2 - - 80 0 2
7/5/2019 01:16:00 5.1 5.0 25.5 25.2 - - 80 0 2
7/5/2019 01:17:00 5.1 5.0 25.5 25.2 - - 80 0 2
7/5/2019 01:18:00 5.2 5.0 25.5 25.2 - - 80 0 2
7/5/2019 01:19:00 5.2 5.0 25.5 25.2 - - 80 0 2
7/5/2019 01:20:00 5.2 5.0 25.4 25.2 - - 80 0 2
7/5/2019 01:21:00 5.1 5.0 25.4 25.1 - - 80 0 2
7/5/2019 01:22:00 5.1 5.0 25.4 25.1 - - 80 0 2
7/5/2019 01:23:00 5.0 5.0 25.4 25.1 - - 80 0 2
7/5/2019 01:24:00 5.1 5.0 25.3 25.0 - - 80 0 2
7/5/2019 01:25:00 5.2 5.0 25.3 25.1 - - 80 0 2

-------------------------------------------
Approved by Date Page: 24 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 01:26:00 5.2 5.0 25.3 25.0 - - 80 0 2
7/5/2019 01:27:00 5.2 5.0 25.3 25.0 - - 80 0 2
7/5/2019 01:28:00 5.2 5.0 25.3 24.9 - - 80 0 2
7/5/2019 01:29:00 5.1 5.0 25.3 25.0 - - 80 0 2
7/5/2019 01:30:00 5.1 5.0 25.2 24.9 - - 80 0 2
7/5/2019 01:31:00 5.1 5.0 25.2 24.9 - - 80 0 2
7/5/2019 01:32:00 5.1 5.0 25.2 24.9 - - 80 0 2
7/5/2019 01:33:00 5.1 5.0 25.2 24.9 - - 80 0 2
7/5/2019 01:34:00 5.2 5.0 25.1 24.8 - - 80 0 2
7/5/2019 01:35:00 5.1 5.0 25.1 24.9 - - 80 0 2
7/5/2019 01:36:00 5.1 5.0 25.1 24.8 - - 80 0 2
7/5/2019 01:37:00 5.2 5.0 25.1 24.8 - - 80 0 2
7/5/2019 01:38:00 5.1 5.0 25.1 24.8 - - 80 0 2
7/5/2019 01:39:00 5.2 5.0 25.0 24.7 - - 80 0 2
7/5/2019 01:40:00 5.2 5.0 25.0 24.7 - - 80 0 2
7/5/2019 01:41:00 5.1 5.0 25.0 24.7 - - 80 0 2
7/5/2019 01:42:00 5.1 5.0 25.0 24.7 - - 80 0 2
7/5/2019 01:43:00 5.1 5.0 24.9 24.7 - - 80 0 2
7/5/2019 01:44:00 5.1 5.0 24.9 24.6 - - 80 0 2
7/5/2019 01:45:00 5.1 5.0 24.9 24.7 - - 80 0 2
7/5/2019 01:46:00 5.1 5.0 24.9 24.6 - - 80 0 2
7/5/2019 01:47:00 5.2 5.0 24.9 24.6 - - 80 0 2
7/5/2019 01:48:00 5.2 5.0 24.8 24.6 - - 80 0 2
7/5/2019 01:49:00 5.2 5.0 24.9 24.5 - - 80 0 2
7/5/2019 01:50:00 5.2 5.0 24.8 24.5 - - 80 0 2
7/5/2019 01:51:00 5.1 5.0 24.8 24.5 - - 80 0 2
7/5/2019 01:52:00 5.1 5.0 24.7 24.5 - - 80 0 2

-------------------------------------------
Approved by Date Page: 25 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 01:53:00 5.1 5.0 24.7 24.4 - - 80 0 2
7/5/2019 01:54:00 5.1 5.0 24.7 24.4 - - 80 0 2
7/5/2019 01:55:00 5.1 5.0 24.7 24.4 - - 80 0 2
7/5/2019 01:56:00 5.1 5.0 24.7 24.4 - - 80 0 2
7/5/2019 01:57:00 5.2 5.0 24.7 24.4 - - 80 0 2
7/5/2019 01:58:00 5.2 5.0 24.6 24.3 - - 80 0 2
7/5/2019 01:59:00 5.2 5.0 24.6 24.3 - - 80 0 2
7/5/2019 02:00:00 5.1 5.0 24.6 24.3 - - 80 0 2
7/5/2019 02:01:00 5.1 5.0 24.6 24.3 - - 80 0 2
7/5/2019 02:02:00 5.1 5.0 24.6 24.3 - - 80 0 2
7/5/2019 02:03:00 5.1 5.0 24.5 24.3 - - 80 0 2
7/5/2019 02:04:00 5.2 5.0 24.5 24.2 - - 80 0 2
7/5/2019 02:05:00 5.2 5.0 24.5 24.2 - - 80 0 2
7/5/2019 02:06:00 5.2 5.0 24.5 24.2 - - 80 0 2
7/5/2019 02:07:00 5.1 5.0 24.4 24.1 - - 80 0 2
7/5/2019 02:08:00 5.2 5.0 24.4 24.1 - - 80 0 2
7/5/2019 02:09:00 5.1 5.0 24.4 24.1 - - 80 0 2
7/5/2019 02:10:00 5.1 5.0 24.4 24.1 - - 80 0 2
7/5/2019 02:11:00 5.1 5.0 24.4 24.1 - - 80 0 2
7/5/2019 02:12:00 5.1 5.0 24.3 24.1 - - 80 0 2
7/5/2019 02:13:00 5.1 5.0 24.3 24.1 - - 80 0 2
7/5/2019 02:14:00 5.2 5.0 24.3 24.0 - - 80 0 2
7/5/2019 02:15:00 5.2 5.0 24.3 24.0 - - 80 0 2
7/5/2019 02:16:00 5.1 5.0 24.3 24.0 - - 80 0 2
7/5/2019 02:17:00 5.1 5.0 24.2 24.0 - - 80 0 2
7/5/2019 02:18:00 5.1 5.0 24.3 23.9 - - 80 0 2
7/5/2019 02:19:00 5.1 5.0 24.2 23.9 - - 80 0 2

-------------------------------------------
Approved by Date Page: 26 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 02:20:00 5.1 5.0 24.2 23.9 - - 80 0 2
7/5/2019 02:21:00 5.2 5.0 24.2 23.9 - - 80 0 2
7/5/2019 02:22:00 5.2 5.0 24.1 23.9 - - 80 0 2
7/5/2019 02:23:00 5.2 5.0 24.1 23.9 - - 80 0 2
7/5/2019 02:24:00 5.1 5.0 24.1 23.8 - - 80 0 2
7/5/2019 02:25:00 5.1 5.0 24.1 23.8 - - 80 0 2
7/5/2019 02:26:00 5.1 5.0 24.1 23.8 - - 80 0 2
7/5/2019 02:27:00 5.0 5.0 24.0 23.7 - - 80 0 2
7/5/2019 02:28:00 5.1 5.0 24.0 23.7 - - 80 0 2
7/5/2019 02:29:00 5.1 5.0 24.0 23.7 - - 80 0 2
7/5/2019 02:30:00 5.1 5.0 24.0 23.7 - - 80 0 2
7/5/2019 02:31:00 5.1 5.0 24.0 23.7 - - 80 0 2
7/5/2019 02:32:00 5.2 5.0 24.0 23.7 - - 80 0 2
7/5/2019 02:33:00 5.2 5.0 23.9 23.7 - - 80 0 2
7/5/2019 02:34:00 5.2 5.0 23.9 23.6 - - 80 0 2
7/5/2019 02:35:00 5.1 5.0 23.9 23.6 - - 80 0 2
7/5/2019 02:36:00 5.1 5.0 23.9 23.6 - - 80 0 2
7/5/2019 02:37:00 5.1 5.0 23.9 23.6 - - 80 0 2
7/5/2019 02:38:00 5.2 5.0 23.8 23.5 - - 80 0 2
7/5/2019 02:39:00 5.2 5.0 23.8 23.5 - - 80 0 2
7/5/2019 02:40:00 5.2 5.0 23.8 23.5 - - 80 0 2
7/5/2019 02:41:00 5.1 5.0 23.8 23.5 - - 80 0 2
7/5/2019 02:42:00 5.1 5.0 23.7 23.5 - - 80 0 2
7/5/2019 02:43:00 5.1 5.0 23.7 23.5 - - 80 0 2
7/5/2019 02:44:00 5.1 5.0 23.7 23.5 - - 80 0 2
7/5/2019 02:45:00 5.1 5.0 23.7 23.4 - - 80 0 2
7/5/2019 02:46:00 5.1 5.0 23.7 23.4 - - 80 0 2

-------------------------------------------
Approved by Date Page: 27 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 02:47:00 5.1 5.0 23.7 23.4 - - 80 0 2
7/5/2019 02:48:00 5.1 5.0 23.7 23.4 - - 80 0 2
7/5/2019 02:49:00 5.2 5.0 23.6 23.4 - - 80 0 2
7/5/2019 02:50:00 5.2 5.0 23.6 23.4 - - 80 0 2
7/5/2019 02:51:00 5.1 5.0 23.6 23.3 - - 80 0 2
7/5/2019 02:52:00 5.1 5.0 23.6 23.3 - - 80 0 2
7/5/2019 02:53:00 5.1 5.0 23.5 23.3 - - 80 0 2
7/5/2019 02:54:00 5.1 5.0 23.5 23.3 - - 80 0 2
7/5/2019 02:55:00 5.1 5.0 23.5 23.2 - - 80 0 2
7/5/2019 02:56:00 5.1 5.0 23.5 23.2 - - 80 0 2
7/5/2019 02:57:00 5.1 5.0 23.5 23.2 - - 80 0 2
7/5/2019 02:58:00 5.2 5.0 23.5 23.2 - - 80 0 2
7/5/2019 02:59:00 5.2 5.0 23.4 23.2 - - 80 0 2
7/5/2019 03:00:00 5.2 5.0 23.4 23.1 - - 80 0 2
7/5/2019 03:01:00 5.1 5.0 23.4 23.1 - - 80 0 2
7/5/2019 03:02:00 5.1 5.0 23.4 23.1 - - 80 0 2
7/5/2019 03:03:00 5.1 5.0 23.4 23.1 - - 80 0 2
7/5/2019 03:04:00 5.1 5.0 23.3 23.1 - - 80 0 2
7/5/2019 03:05:00 5.1 5.0 23.3 23.0 - - 80 0 2
7/5/2019 03:06:00 5.1 5.0 23.3 23.0 - - 80 0 2
7/5/2019 03:07:00 5.1 5.0 23.3 23.0 - - 80 0 2
7/5/2019 03:08:00 5.1 5.0 23.3 23.0 - - 80 0 2
7/5/2019 03:09:00 5.2 5.0 23.3 23.0 - - 80 0 2
7/5/2019 03:10:00 5.2 5.0 23.2 23.0 - - 80 0 2
7/5/2019 03:11:00 5.1 5.0 23.2 22.9 - - 80 0 2
7/5/2019 03:12:00 5.1 5.0 23.2 22.9 - - 80 0 2
7/5/2019 03:13:00 5.1 5.0 23.2 22.9 - - 80 0 2

-------------------------------------------
Approved by Date Page: 28 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 03:14:00 5.1 5.0 23.1 22.9 - - 80 0 2
7/5/2019 03:15:00 5.2 5.0 23.1 22.8 - - 80 0 2
7/5/2019 03:16:00 5.1 5.0 23.1 22.8 - - 80 0 2
7/5/2019 03:16:17 Audit: - The freeze drying cycle is advanced to the next step by IDIN.
7/5/2019 03:16:18 Event: - Auto freeze drying advanced to next step.
7/5/2019 03:16:20 Event: - Step advanced to [2] Freezing
7/5/2019 03:17:00 5.2 5.0 23.1 22.8 - - 80 0 2
7/5/2019 03:18:00 5.2 5.0 23.0 22.8 - - 80 0 2
7/5/2019 03:19:00 5.1 5.0 23.1 22.8 - - 80 0 2
7/5/2019 03:20:00 5.2 5.0 23.0 22.8 - - 80 0 2
7/5/2019 03:21:00 5.1 5.0 23.0 22.8 - - 80 0 2
7/5/2019 03:22:00 5.1 5.0 23.0 22.8 - - 80 0 2
7/5/2019 03:23:00 5.1 5.0 23.0 22.7 - - 80 0 2
7/5/2019 03:24:00 5.1 5.0 23.0 22.7 - - 80 0 2
7/5/2019 03:25:00 5.1 5.0 23.0 22.7 - - 80 0 2
7/5/2019 03:26:00 5.1 5.0 22.9 22.6 - - 80 0 2
7/5/2019 03:27:00 5.2 5.0 22.9 22.6 - - 80 0 2
7/5/2019 03:28:00 5.1 5.0 22.9 22.6 - - 80 0 2
7/5/2019 03:29:00 5.1 5.0 22.9 22.6 - - 80 0 2
7/5/2019 03:30:00 5.1 5.0 22.8 22.6 - - 80 0 2
7/5/2019 03:31:00 5.1 5.0 22.8 22.6 - - 80 0 2
7/5/2019 03:32:00 5.1 5.0 22.8 22.5 - - 80 0 2
7/5/2019 03:33:00 5.1 5.0 22.8 22.5 - - 80 0 2
7/5/2019 03:34:00 5.1 5.0 22.8 22.5 - - 80 0 2
7/5/2019 03:35:00 5.1 5.0 22.8 22.5 - - 80 0 2
7/5/2019 03:36:00 5.1 5.0 22.7 22.5 - - 80 0 2
7/5/2019 03:37:00 5.1 5.0 22.7 22.5 - - 80 0 2

-------------------------------------------
Approved by Date Page: 29 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 03:38:00 5.1 5.0 22.7 22.5 - - 80 0 2
7/5/2019 03:39:00 5.1 5.0 22.7 22.4 - - 80 0 2
7/5/2019 03:40:00 5.2 5.0 22.6 22.4 - - 80 0 2
7/5/2019 03:41:00 5.1 5.0 22.6 22.4 - - 80 0 2
7/5/2019 03:42:00 5.1 5.0 22.6 22.4 - - 80 0 1
7/5/2019 03:43:00 5.1 5.0 22.6 22.4 - - 80 0 2
7/5/2019 03:44:00 5.1 5.0 22.6 22.4 - - 80 0 1
7/5/2019 03:45:00 5.1 5.0 22.6 22.4 - - 80 0 1
7/5/2019 03:46:00 5.2 5.0 22.6 22.3 - - 80 0 1
7/5/2019 03:46:20 Event: - Step advanced to [3] Freezing
7/5/2019 03:47:00 5.1 4.6 22.5 22.3 - - 80 0 1
7/5/2019 03:48:00 4.7 4.2 22.5 22.2 - - 80 0 1
7/5/2019 03:49:00 4.5 3.6 22.5 22.2 - - 80 0 1
7/5/2019 03:50:00 4.2 3.2 22.5 22.2 - - 80 0 2
7/5/2019 03:51:00 3.7 2.6 22.5 22.2 - - 80 0 2
7/5/2019 03:52:00 3.2 2.2 22.4 22.2 - - 80 0 2
7/5/2019 03:53:00 2.5 1.6 22.4 22.2 - - 80 0 2
7/5/2019 03:54:00 2.1 1.2 22.4 22.2 - - 80 0 2
7/5/2019 03:55:00 1.7 0.6 22.4 22.1 - - 80 0 2
7/5/2019 03:56:00 1.2 0.2 22.4 22.2 - - 80 0 2
7/5/2019 03:57:00 0.4 -0.4 22.3 22.1 - - 80 0 2
7/5/2019 03:58:00 -0.3 -0.8 22.4 22.1 - - 80 0 2
7/5/2019 03:59:00 -1.3 -1.4 22.4 22.1 - - 80 0 2
7/5/2019 04:00:00 -1.4 -1.8 22.3 22.0 - - 80 0 2
7/5/2019 04:01:00 -1.2 -2.4 22.3 22.1 - - 80 0 2
7/5/2019 04:02:00 -1.3 -2.8 22.3 22.0 - - 80 0 1
7/5/2019 04:03:00 -2.0 -3.4 22.2 22.0 - - 80 0 1

-------------------------------------------
Approved by Date Page: 30 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 04:04:00 -2.9 -3.8 22.2 22.0 - - 80 0 1
7/5/2019 04:05:00 -3.4 -4.4 22.2 22.0 - - 80 0 1
7/5/2019 04:06:00 -3.9 -4.8 22.2 22.0 - - 80 0 1
7/5/2019 04:07:00 -5.2 -5.4 22.2 22.0 - - 80 0 1
7/5/2019 04:08:00 -6.4 -5.8 22.2 21.9 - - 80 0 1
7/5/2019 04:09:00 -6.5 -6.4 22.2 21.9 - - 80 0 1
7/5/2019 04:10:00 -6.9 -6.8 22.2 21.9 - - 80 0 1
7/5/2019 04:11:00 -6.8 -7.4 22.1 21.9 - - 80 0 1
7/5/2019 04:12:00 -6.9 -7.8 22.1 21.9 - - 80 0 1
7/5/2019 04:13:00 -8.0 -8.4 22.1 21.9 - - 80 0 1
7/5/2019 04:14:00 -8.4 -8.8 22.1 21.8 - - 80 0 1
7/5/2019 04:15:00 -8.8 -9.4 22.1 21.8 - - 80 0 1
7/5/2019 04:16:00 -9.2 -9.8 22.0 21.8 - - 80 0 1
7/5/2019 04:17:00 -9.6 -10.4 22.0 21.8 - - 80 0 1
7/5/2019 04:18:00 -10.0 -10.8 22.0 21.8 - - 80 0 1
7/5/2019 04:19:00 -10.6 -11.4 22.0 21.7 - - 80 0 1
7/5/2019 04:20:00 -10.9 -11.8 22.0 21.7 - - 80 0 1
7/5/2019 04:21:00 -11.4 -12.4 22.0 21.7 - - 80 0 1
7/5/2019 04:22:00 -11.9 -12.8 21.9 21.7 - - 80 0 1
7/5/2019 04:23:00 -12.3 -13.4 21.9 21.7 - - 80 0 1
7/5/2019 04:24:00 -12.6 -13.8 21.9 21.7 - - 80 0 1
7/5/2019 04:25:00 -13.0 -14.4 21.9 21.7 - - 80 0 1
7/5/2019 04:26:00 -13.6 -14.8 21.8 21.6 - - 80 0 1
7/5/2019 04:27:00 -13.7 -15.4 21.9 21.7 - - 80 0 1
7/5/2019 04:28:00 -14.2 -15.8 21.8 21.6 - - 80 0 1
7/5/2019 04:29:00 -14.7 -16.4 21.8 21.6 - - 80 0 1
7/5/2019 04:30:00 -15.1 -16.8 21.8 21.6 - - 80 0 1

-------------------------------------------
Approved by Date Page: 31 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 04:31:00 -15.5 -17.4 21.8 21.6 - - 80 0 1
7/5/2019 04:32:00 -15.8 -17.8 21.8 21.5 - - 80 0 1
7/5/2019 04:33:00 -16.0 -18.4 21.7 21.5 - - 80 0 1
7/5/2019 04:34:00 -16.3 -18.8 21.7 21.5 - - 80 0 1
7/5/2019 04:35:00 -16.9 -19.4 21.7 21.5 - - 80 0 1
7/5/2019 04:36:00 -16.9 -19.8 21.7 21.4 - - 80 0 1
7/5/2019 04:37:00 -17.6 -20.4 21.7 21.4 - - 80 0 1
7/5/2019 04:38:00 -17.7 -20.8 21.7 21.4 - - 80 0 1
7/5/2019 04:39:00 -17.9 -21.4 21.6 21.4 - - 80 0 1
7/5/2019 04:40:00 -18.4 -21.8 21.6 21.4 - - 80 0 1
7/5/2019 04:40:10 Event: - Auto freeze cycle hold mode activated.
7/5/2019 04:41:00 -17.9 -21.9 21.6 21.4 - - 80 0 1
7/5/2019 04:42:00 -18.5 -21.9 21.6 21.4 - - 80 0 1
7/5/2019 04:43:00 -18.9 -21.9 21.6 21.4 - - 80 0 1
7/5/2019 04:44:00 -18.8 -21.9 21.6 21.4 - - 80 0 1
7/5/2019 04:45:00 -18.9 -21.9 21.5 21.3 - - 80 0 1
7/5/2019 04:46:00 -19.0 -21.9 21.5 21.3 - - 80 0 1
7/5/2019 04:47:00 -18.9 -21.9 21.5 21.3 - - 80 0 1
7/5/2019 04:48:00 -19.0 -21.9 21.5 21.3 - - 80 0 1
7/5/2019 04:49:00 -19.3 -21.9 21.4 21.2 - - 80 0 1
7/5/2019 04:50:00 -19.6 -21.9 21.4 21.2 - - 80 0 1
7/5/2019 04:51:00 -19.3 -21.9 21.4 21.2 - - 80 0 1
7/5/2019 04:52:00 -19.4 -21.9 21.4 21.2 - - 80 0 1
7/5/2019 04:53:00 -18.8 -21.9 21.4 21.2 - - 80 0 1
7/5/2019 04:54:00 -18.7 -21.9 21.4 21.2 - - 80 0 1
7/5/2019 04:55:00 -18.6 -21.9 21.4 21.1 - - 80 0 1
7/5/2019 04:56:00 -18.6 -21.9 21.3 21.1 - - 80 0 1

-------------------------------------------
Approved by Date Page: 32 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 04:57:00 -19.4 -21.9 21.3 21.1 - - 80 0 1
7/5/2019 04:58:00 -20.1 -21.9 21.3 21.1 - - 80 0 1
7/5/2019 04:59:00 -20.3 -21.9 21.3 21.1 - - 80 0 1
7/5/2019 04:59:40 Event: - Auto freeze cycle hold mode exited.
7/5/2019 05:00:00 -21.1 -22.1 21.3 21.1 - - 80 0 1
7/5/2019 05:01:00 -21.4 -22.6 21.2 21.0 - - 80 0 1
7/5/2019 05:02:00 -21.9 -23.1 21.2 21.0 - - 80 0 1
7/5/2019 05:03:00 -22.2 -23.6 21.2 21.0 - - 80 0 1
7/5/2019 05:04:00 -22.5 -24.1 21.2 21.0 - - 80 0 1
7/5/2019 05:05:00 -22.8 -24.6 21.2 21.0 - - 80 0 1
7/5/2019 05:06:00 -23.1 -25.1 21.2 21.0 - - 80 0 1
7/5/2019 05:07:00 -23.6 -25.6 21.1 20.9 - - 80 0 1
7/5/2019 05:08:00 -23.8 -26.1 21.1 20.9 - - 80 0 1
7/5/2019 05:09:00 -23.9 -26.6 21.1 20.9 - - 80 0 1
7/5/2019 05:10:00 -24.1 -27.1 21.1 20.9 - - 80 0 1
7/5/2019 05:11:00 -24.2 -27.6 21.1 20.9 - - 80 0 1
7/5/2019 05:12:00 -24.4 -28.1 21.1 20.9 - - 80 0 1
7/5/2019 05:12:55 Event: - Auto freeze cycle hold mode activated.
7/5/2019 05:13:00 -24.6 -28.6 21.1 20.9 - - 80 0 1
7/5/2019 05:13:55 Alarm: CLOSE - Heater failure.
7/5/2019 05:14:00 -24.0 -28.6 21.1 20.9 - - 80 0 1
7/5/2019 05:15:00 -25.1 -28.6 21.0 20.8 - - 80 0 1
7/5/2019 05:16:00 -24.9 -28.6 21.0 20.9 - - 80 0 1
7/5/2019 05:17:00 -25.5 -28.6 21.0 20.8 - - 80 0 1
7/5/2019 05:18:00 -25.7 -28.6 21.0 20.8 - - 80 0 1
7/5/2019 05:19:00 -25.7 -28.6 21.0 20.8 - - 80 0 1
7/5/2019 05:20:00 -25.8 -28.6 21.0 20.8 - - 80 0 1

-------------------------------------------
Approved by Date Page: 33 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 05:21:00 -25.9 -28.6 21.0 20.8 - - 80 0 1
7/5/2019 05:22:00 -25.7 -28.6 20.9 20.7 - - 80 0 1
7/5/2019 05:23:00 -26.4 -28.6 20.9 20.8 - - 80 0 1
7/5/2019 05:24:00 -26.6 -28.6 20.9 20.7 - - 80 0 1
7/5/2019 05:25:00 -26.8 -28.6 20.9 20.7 - - 80 0 1
7/5/2019 05:26:00 -27.0 -28.6 20.9 20.7 - - 80 0 1
7/5/2019 05:27:00 -27.1 -28.6 20.9 20.7 - - 80 0 1
7/5/2019 05:28:00 -27.3 -28.6 20.8 20.6 - - 80 0 1
7/5/2019 05:29:00 -27.4 -28.6 20.8 20.6 - - 80 0 1
7/5/2019 05:30:00 -27.4 -28.6 20.8 20.6 - - 80 0 1
7/5/2019 05:31:00 -27.5 -28.6 20.8 20.6 - - 80 0 1
7/5/2019 05:32:00 -27.5 -28.6 20.8 20.6 - - 80 0 1
7/5/2019 05:33:00 -27.6 -28.6 20.8 20.6 - - 80 0 1
7/5/2019 05:33:55 Event: - Auto freeze cycle hold mode exited.
7/5/2019 05:34:00 -27.7 -28.6 20.8 20.6 - - 80 0 1
7/5/2019 05:35:00 -27.8 -29.2 20.8 20.6 - - 80 0 1
7/5/2019 05:36:00 -27.8 -29.6 20.8 20.6 - - 80 0 1
7/5/2019 05:37:00 -27.9 -30.2 20.7 20.5 - - 80 0 1
7/5/2019 05:38:00 -28.0 -30.6 20.7 20.5 - - 80 0 1
7/5/2019 05:39:00 -28.1 -31.2 20.7 20.5 - - 80 0 1
7/5/2019 05:40:00 -28.1 -31.6 20.6 20.5 - - 80 0 1
7/5/2019 05:41:00 -28.2 -32.2 20.6 20.5 - - 80 0 1
7/5/2019 05:41:20 Event: - Auto freeze cycle hold mode activated.
7/5/2019 05:42:00 -28.3 -32.3 20.6 20.5 - - 80 0 1
7/5/2019 05:43:00 -28.4 -32.3 20.7 20.5 - - 80 0 1
7/5/2019 05:44:00 -28.5 -32.3 20.6 20.5 - - 80 0 1
7/5/2019 05:45:00 -28.6 -32.3 20.6 20.4 - - 80 0 1

-------------------------------------------
Approved by Date Page: 34 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 05:46:00 -28.7 -32.3 20.6 20.4 - - 80 0 1
7/5/2019 05:47:00 -28.1 -32.3 20.6 20.4 - - 80 0 1
7/5/2019 05:48:00 -28.7 -32.3 20.6 20.4 - - 80 0 1
7/5/2019 05:49:00 -28.3 -32.3 20.6 20.4 - - 80 0 1
7/5/2019 05:50:00 -28.8 -32.3 20.5 20.3 - - 80 0 1
7/5/2019 05:51:00 -28.9 -32.3 20.5 20.3 - - 80 0 1
7/5/2019 05:52:00 -29.0 -32.3 20.5 20.3 - - 80 0 1
7/5/2019 05:53:00 -29.2 -32.3 20.5 20.3 - - 80 0 1
7/5/2019 05:54:00 -29.4 -32.3 20.5 20.3 - - 80 0 1
7/5/2019 05:55:00 -29.5 -32.3 20.4 20.3 - - 80 0 1
7/5/2019 05:56:00 -29.6 -32.3 20.4 20.3 - - 80 0 1
7/5/2019 05:57:00 -29.7 -32.3 20.4 20.3 - - 80 0 1
7/5/2019 05:57:16 Alarm: CLOSE - COM1 discharge high pressure.
Alarm: CLOSE - PSL35 cooling water low pressure.
7/5/2019 05:58:00 -29.2 -32.3 20.4 20.2 - - 80 0 1
7/5/2019 05:58:48 Audit: - Alarm is reset manually by IDIN.
7/5/2019 05:58:50 Audit: - A_COM1DISCHP ALARM is acknowledged by IDIN.
Audit: - A_COOLWATERLOWPRES ALARM is acknowledged by IDIN.
Audit: - A_HTRFAIL ALARM is acknowledged by IDIN.
7/5/2019 05:58:54 Audit: - Alarm is reset manually by IDIN.
7/5/2019 05:59:00 -29.1 -32.3 20.4 20.2 - - 80 0 1
7/5/2019 06:00:00 -29.0 -32.3 20.4 20.2 - - 80 0 1
7/5/2019 06:01:00 -29.0 -32.3 20.4 20.2 - - 80 0 1
7/5/2019 06:02:00 -29.0 -32.3 20.4 20.2 - - 80 0 1
7/5/2019 06:03:00 -28.9 -32.3 20.3 20.2 - - 80 0 1
7/5/2019 06:04:00 -28.9 -32.3 20.3 20.2 - - 80 0 1
7/5/2019 06:05:00 -29.0 -32.3 20.3 20.2 - - 80 0 1

-------------------------------------------
Approved by Date Page: 35 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 06:06:00 -29.0 -32.3 20.3 20.1 - - 80 0 1
7/5/2019 06:07:00 -29.0 -32.3 20.3 20.1 - - 80 0 1
7/5/2019 06:08:00 -29.0 -32.3 20.3 20.1 - - 80 0 1
7/5/2019 06:09:00 -29.0 -32.3 20.3 20.1 - - 80 0 1
7/5/2019 06:10:00 -29.1 -32.3 20.2 20.1 - - 80 0 1
7/5/2019 06:11:00 -29.1 -32.3 20.2 20.1 - - 80 0 1
7/5/2019 06:12:00 -29.2 -32.3 20.2 20.1 - - 80 0 1
7/5/2019 06:13:00 -29.2 -32.3 20.2 20.1 - - 80 0 1
7/5/2019 06:14:00 -29.3 -32.3 20.2 20.0 - - 80 0 1
7/5/2019 06:15:00 -29.3 -32.3 20.2 20.1 - - 80 0 1
7/5/2019 06:16:00 -29.4 -32.3 20.1 20.0 - - 80 0 1
7/5/2019 06:17:00 -29.4 -32.3 20.1 20.0 - - 80 0 1
7/5/2019 06:18:00 -29.5 -32.3 20.1 20.0 - - 80 0 1
7/5/2019 06:18:05 Audit: - Alarm is reset manually by IDIN.
7/5/2019 06:19:00 -29.5 -32.3 20.1 20.0 - - 80 0 1
7/5/2019 06:20:00 -29.6 -32.3 20.1 20.0 - - 80 0 1
7/5/2019 06:20:35 Alarm: CLOSE - PSL35 cooling water low pressure.
7/5/2019 06:21:00 -29.6 -32.3 20.1 20.0 - - 80 0 1
7/5/2019 06:21:12 Alarm: CLOSE - COM2 discharge high pressure.
7/5/2019 06:22:00 -28.6 -32.3 20.1 20.0 - - 80 0 1
Audit: - A_COM2DISCHP ALARM is acknowledged by IDIN.
Audit: - A_COOLWATERLOWPRES ALARM is acknowledged by IDIN.
7/5/2019 06:22:02 Audit: - Alarm is reset manually by IDIN.
7/5/2019 06:23:00 -28.3 -32.3 20.1 20.0 - - 80 0 1
7/5/2019 06:24:00 -27.9 -32.3 20.1 19.9 - - 80 0 1
7/5/2019 06:25:00 -27.6 -32.3 20.1 19.9 - - 80 0 1
7/5/2019 06:25:32 Audit: - Alarm is reset manually by IDIN.

-------------------------------------------
Approved by Date Page: 36 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 06:26:00 -28.3 -32.3 20.1 19.9 - - 80 0 1
7/5/2019 06:27:00 -28.7 -32.3 20.0 19.9 - - 80 0 1
7/5/2019 06:28:00 -28.9 -32.3 20.0 19.9 - - 80 0 1
7/5/2019 06:29:00 -29.4 -32.3 20.0 19.9 - - 80 0 1
7/5/2019 06:30:00 -29.7 -32.3 20.0 19.9 - - 80 0 1
7/5/2019 06:31:00 -30.0 -32.3 20.0 19.9 - - 80 0 1
7/5/2019 06:32:00 -30.3 -32.3 20.0 19.8 - - 80 0 1
7/5/2019 06:33:00 -30.6 -32.3 20.0 19.8 - - 80 0 1
7/5/2019 06:34:00 -30.9 -32.3 20.0 19.8 - - 80 0 1
7/5/2019 06:35:00 -30.6 -32.3 19.9 19.8 - - 80 0 1
7/5/2019 06:36:00 -29.9 -32.3 19.9 19.8 - - 80 0 1
7/5/2019 06:37:00 -31.1 -32.3 20.0 19.8 - - 80 0 1
7/5/2019 06:37:15 Event: - Auto freeze cycle hold mode exited.
7/5/2019 06:38:00 -30.9 -32.7 19.9 19.8 - - 80 0 1
7/5/2019 06:39:00 -31.2 -33.2 19.9 19.8 - - 80 0 1
7/5/2019 06:40:00 -31.3 -33.7 19.9 19.7 - - 80 0 1
7/5/2019 06:41:00 -31.2 -34.2 19.9 19.7 - - 80 0 1
7/5/2019 06:41:32 Alarm: CLOSE - Heater failure.
7/5/2019 06:42:00 -31.7 -34.7 19.9 19.8 - - 80 0 1
7/5/2019 06:42:49 Alarm: CLOSE - Heater failure.
7/5/2019 06:43:00 -31.7 -35.2 19.9 19.8 - - 80 0 1
7/5/2019 06:43:01 Audit: - A_HTRFAIL ALARM is acknowledged by IDIN.
7/5/2019 06:43:02 Audit: - Alarm is reset manually by IDIN.
7/5/2019 06:43:23 Alarm: CLOSE - Heater failure.
7/5/2019 06:43:33 Audit: - A_HTRFAIL ALARM is acknowledged by IDIN.
7/5/2019 06:43:35 Audit: - Alarm is reset manually by IDIN.
7/5/2019 06:44:00 -31.8 -35.7 19.8 19.7 - - 80 0 1

-------------------------------------------
Approved by Date Page: 37 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 06:44:25 Event: - Auto freeze cycle hold mode activated.
7/5/2019 06:45:00 -32.0 -35.9 19.8 19.7 - - 80 0 1
7/5/2019 06:46:00 -32.2 -35.9 19.8 19.7 - - 80 0 1
7/5/2019 06:46:28 Alarm: CLOSE - Heater failure.
7/5/2019 06:47:00 -31.0 -35.9 19.8 19.7 - - 80 0 1
7/5/2019 06:48:00 -29.7 -35.9 19.8 19.7 - - 80 0 1
7/5/2019 06:49:00 -30.1 -35.9 19.8 19.7 - - 80 0 1
7/5/2019 06:50:00 -29.9 -35.9 19.7 19.6 - - 80 0 1
7/5/2019 06:51:00 -31.1 -35.9 19.7 19.6 - - 80 0 1
7/5/2019 06:52:00 -30.8 -35.9 19.7 19.6 - - 80 0 1
7/5/2019 06:53:00 -30.6 -35.9 19.7 19.6 - - 80 0 1
7/5/2019 06:54:00 -31.2 -35.9 19.7 19.5 - - 80 0 1
7/5/2019 06:55:00 -31.4 -35.9 19.7 19.5 - - 80 0 1
7/5/2019 06:56:00 -31.8 -35.9 19.6 19.5 - - 80 0 1
7/5/2019 06:57:00 -31.9 -35.9 19.6 19.5 - - 80 0 1
7/5/2019 06:58:00 -32.3 -35.9 19.7 19.5 - - 80 0 1
7/5/2019 06:59:00 -32.5 -35.9 19.6 19.5 - - 80 0 1
7/5/2019 07:00:00 -32.7 -35.9 19.6 19.5 - - 80 0 1
7/5/2019 07:01:00 -33.0 -35.9 19.6 19.5 - - 80 0 1
7/5/2019 07:02:00 -33.3 -35.9 19.6 19.5 - - 80 0 1
7/5/2019 07:03:00 -33.5 -35.9 19.5 19.5 - - 80 0 1
7/5/2019 07:04:00 -33.8 -35.9 19.5 19.4 - - 80 0 1
7/5/2019 07:05:00 -34.0 -35.9 19.5 19.4 - - 80 0 1
7/5/2019 07:06:00 -34.2 -35.9 19.5 19.4 - - 80 0 1
7/5/2019 07:07:00 -34.4 -35.9 19.5 19.4 - - 80 0 1
7/5/2019 07:08:00 -34.7 -35.9 19.5 19.3 - - 80 0 1
7/5/2019 07:09:00 -34.9 -35.9 19.5 19.3 - - 80 0 1

-------------------------------------------
Approved by Date Page: 38 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 07:09:10 Event: - Auto freeze cycle hold mode exited.
7/5/2019 07:10:00 -35.2 -36.4 19.5 19.3 - - 80 0 1
7/5/2019 07:11:00 -35.4 -36.8 19.5 19.3 - - 80 0 1
7/5/2019 07:12:00 -35.6 -37.4 19.4 19.3 - - 80 0 1
7/5/2019 07:13:00 -35.8 -37.8 19.4 19.3 - - 80 0 1
7/5/2019 07:14:00 -36.0 -38.4 19.4 19.2 - - 80 0 1
7/5/2019 07:15:00 -36.2 -38.8 19.4 19.3 - - 80 0 1
7/5/2019 07:16:00 -36.4 -39.4 19.4 19.2 - - 80 0 1
7/5/2019 07:17:00 -36.6 -39.8 19.4 19.3 - - 80 0 1
7/5/2019 07:18:00 -36.7 -40.4 19.3 19.2 - - 80 0 1
7/5/2019 07:19:00 -36.9 -40.8 19.3 19.2 - - 80 0 1
7/5/2019 07:19:10 Event: - Auto freeze cycle hold mode activated.
7/5/2019 07:20:00 -37.1 -41.0 19.3 19.2 - - 80 0 1
7/5/2019 07:21:00 -37.3 -41.0 19.3 19.2 - - 80 0 1
7/5/2019 07:22:00 -37.4 -41.0 19.3 19.1 - - 80 0 1
7/5/2019 07:23:00 -37.6 -41.0 19.3 19.2 - - 80 0 1
7/5/2019 07:24:00 -37.6 -41.0 19.3 19.2 - - 80 0 1
7/5/2019 07:25:00 -37.6 -41.0 19.3 19.1 - - 80 0 1
7/5/2019 07:26:00 -37.8 -41.0 19.2 19.1 - - 80 0 1
7/5/2019 07:27:00 -37.8 -41.0 19.2 19.1 - - 80 0 1
7/5/2019 07:28:00 -38.0 -41.0 19.2 19.1 - - 80 0 1
7/5/2019 07:29:00 -38.0 -41.0 19.2 19.1 - - 80 0 1
7/5/2019 07:30:00 -38.1 -41.0 19.2 19.1 - - 80 0 1
7/5/2019 07:31:00 -38.1 -41.0 19.2 19.1 - - 80 0 1
7/5/2019 07:32:00 -38.2 -41.0 19.1 19.0 - - 80 0 1
7/5/2019 07:33:00 -38.3 -41.0 19.2 19.0 - - 80 0 1
7/5/2019 07:34:00 -38.4 -41.0 19.1 19.0 - - 80 0 1

-------------------------------------------
Approved by Date Page: 39 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 07:35:00 -38.4 -41.0 19.1 19.0 - - 80 0 1
7/5/2019 07:36:00 -38.5 -41.0 19.1 19.0 - - 80 0 1
7/5/2019 07:37:00 -38.6 -41.0 19.1 19.0 - - 80 0 1
7/5/2019 07:38:00 -38.6 -41.0 19.0 18.9 - - 80 0 1
7/5/2019 07:39:00 -38.7 -41.0 19.0 18.9 - - 80 0 1
7/5/2019 07:40:00 -38.7 -41.0 19.0 18.9 - - 80 0 1
7/5/2019 07:41:00 -38.8 -41.0 19.0 18.9 - - 80 0 1
7/5/2019 07:42:00 -39.0 -41.0 19.0 18.9 - - 80 0 1
7/5/2019 07:42:58 Alarm: CLOSE - Heater failure.
7/5/2019 07:43:00 -39.0 -41.0 19.0 18.9 - - 80 0 1
7/5/2019 07:43:52 Alarm: CLOSE - Heater failure.
7/5/2019 07:44:00 -39.1 -41.0 19.0 18.9 - - 80 0 1
7/5/2019 07:44:08 Alarm: CLOSE - Heater failure.
7/5/2019 07:45:00 -39.2 -41.0 19.0 18.9 - - 80 0 1
7/5/2019 07:46:00 -39.2 -41.0 18.9 18.8 - - 80 0 1
7/5/2019 07:47:00 -39.2 -41.0 19.0 18.8 - - 80 0 1
7/5/2019 07:48:00 -39.3 -41.0 18.9 18.8 - - 80 0 1
7/5/2019 07:49:00 -39.4 -41.0 18.9 18.8 - - 80 0 1
7/5/2019 07:50:00 -39.5 -41.0 18.9 18.8 - - 80 0 1
7/5/2019 07:51:00 -39.6 -41.0 18.9 18.8 - - 80 0 1
7/5/2019 07:52:00 -39.6 -41.0 18.9 18.7 - - 80 0 1
7/5/2019 07:53:00 -39.7 -41.0 18.9 18.7 - - 80 0 1
7/5/2019 07:54:00 -39.7 -41.0 18.9 18.7 - - 80 0 1
7/5/2019 07:55:00 -39.7 -41.0 18.9 18.7 - - 80 0 1
7/5/2019 07:56:00 -39.8 -41.0 18.8 18.7 - - 80 0 1
7/5/2019 07:57:00 -39.9 -41.0 18.8 18.7 - - 80 0 1
7/5/2019 07:58:00 -39.9 -41.0 18.8 18.7 - - 80 0 1

-------------------------------------------
Approved by Date Page: 40 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 07:59:00 -40.1 -41.0 18.7 18.6 - - 80 0 1
Event: - Auto freeze cycle hold mode exited.
7/5/2019 08:00:00 -40.1 -41.5 18.7 18.7 - - 80 0 1
7/5/2019 08:01:00 -40.2 -42.0 18.7 18.7 - - 80 0 1
7/5/2019 08:02:00 -40.3 -42.5 18.7 18.6 - - 80 0 1
7/5/2019 08:03:00 -40.4 -43.0 18.7 18.6 - - 80 0 1
7/5/2019 08:04:00 -40.3 -43.5 18.7 18.6 - - 80 0 1
7/5/2019 08:05:00 -40.4 -44.0 18.7 18.6 - - 80 0 1
7/5/2019 08:06:00 -40.5 -44.5 18.6 18.5 - - 80 0 1
7/5/2019 08:06:05 Event: - Auto freeze cycle hold mode activated.
7/5/2019 08:07:00 -40.5 -44.5 18.7 18.5 - - 80 0 1
7/5/2019 08:08:00 -40.6 -44.5 18.7 18.5 - - 80 0 1
7/5/2019 08:09:00 -40.6 -44.5 18.7 18.5 - - 80 0 1
7/5/2019 08:10:00 -40.7 -44.5 18.6 18.5 - - 80 0 1
7/5/2019 08:11:00 -40.7 -44.5 18.6 18.5 - - 80 0 1
7/5/2019 08:12:00 -40.8 -44.5 18.6 18.5 - - 80 0 1
7/5/2019 08:13:00 -40.9 -44.5 18.6 18.5 - - 80 0 1
7/5/2019 08:14:00 -41.0 -44.5 18.6 18.4 - - 80 0 1
7/5/2019 08:15:00 -41.0 -44.5 18.5 18.4 - - 80 0 1
7/5/2019 08:16:00 -41.1 -44.5 18.5 18.4 - - 80 0 1
7/5/2019 08:17:00 -41.1 -44.5 18.5 18.4 - - 80 0 1
7/5/2019 08:18:00 -41.2 -44.5 18.5 18.4 - - 80 0 1
7/5/2019 08:19:00 -41.3 -44.5 18.5 18.4 - - 80 0 1
7/5/2019 08:20:00 -41.3 -44.5 18.5 18.4 - - 80 0 1
7/5/2019 08:21:00 -41.4 -44.5 18.5 18.4 - - 80 0 1
7/5/2019 08:22:00 -41.4 -44.5 18.4 18.3 - - 80 0 1
7/5/2019 08:23:00 -41.5 -44.5 18.4 18.3 - - 80 0 1

-------------------------------------------
Approved by Date Page: 41 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 08:24:00 -41.5 -44.5 18.4 18.3 - - 80 0 1
7/5/2019 08:25:00 -41.6 -44.5 18.4 18.3 - - 80 0 1
7/5/2019 08:26:00 -41.7 -44.5 18.4 18.3 - - 80 0 1
7/5/2019 08:27:00 -41.6 -44.5 18.4 18.3 - - 80 0 1
7/5/2019 08:28:00 -41.7 -44.5 18.4 18.3 - - 80 0 1
7/5/2019 08:29:00 -41.7 -44.5 18.4 18.3 - - 80 0 1
7/5/2019 08:30:00 -41.7 -44.5 18.4 18.2 - - 80 0 1
7/5/2019 08:31:00 -41.7 -44.5 18.3 18.2 - - 80 0 1
7/5/2019 08:32:00 -41.8 -44.5 18.3 18.2 - - 80 0 1
7/5/2019 08:33:00 -41.9 -44.5 18.3 18.2 - - 80 0 1
7/5/2019 08:34:00 -41.9 -44.5 18.3 18.2 - - 80 0 1
7/5/2019 08:35:00 -42.0 -44.5 18.3 18.2 - - 80 0 1
7/5/2019 08:36:00 -42.0 -44.5 18.3 18.2 - - 80 0 1
7/5/2019 08:37:00 -42.2 -44.5 18.2 18.2 - - 80 0 1
7/5/2019 08:38:00 -42.1 -44.5 18.2 18.1 - - 80 0 1
7/5/2019 08:39:00 -42.2 -44.5 18.2 18.1 - - 80 0 1
7/5/2019 08:40:00 -42.1 -44.5 18.2 18.2 - - 80 0 1
7/5/2019 08:41:00 -42.1 -44.5 18.2 18.1 - - 80 0 1
7/5/2019 08:42:00 -42.2 -44.5 18.2 18.1 - - 80 0 1
7/5/2019 08:43:00 -42.2 -44.5 18.2 18.1 - - 80 0 1
7/5/2019 08:44:00 -42.0 -44.5 18.2 18.1 - - 80 0 1
7/5/2019 08:45:00 -41.9 -44.5 18.1 18.1 - - 80 0 1
7/5/2019 08:46:00 -42.1 -44.5 18.1 18.0 - - 80 0 1
7/5/2019 08:47:00 -39.5 -44.5 18.1 18.0 - - 80 0 1
7/5/2019 08:48:00 -38.4 -44.5 18.1 17.9 - - 80 0 1
7/5/2019 08:49:00 -39.2 -44.5 18.1 17.9 - - 80 0 1
7/5/2019 08:50:00 -38.1 -44.5 18.1 18.0 - - 80 0 1

-------------------------------------------
Approved by Date Page: 42 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 08:51:00 -37.8 -44.5 18.1 17.9 - - 80 0 1
7/5/2019 08:52:00 -38.9 -44.5 18.1 17.9 - - 80 0 1
7/5/2019 08:53:00 -38.9 -44.5 18.0 17.9 - - 80 0 1
7/5/2019 08:54:00 -38.8 -44.5 18.0 17.9 - - 80 0 1
7/5/2019 08:55:00 -38.8 -44.5 18.0 17.9 - - 80 0 1
7/5/2019 08:56:00 -39.3 -44.5 17.9 17.9 - - 80 0 1
7/5/2019 08:57:00 -39.6 -44.5 17.9 17.9 - - 80 0 1
7/5/2019 08:58:00 -39.8 -44.5 17.9 17.9 - - 80 0 1
7/5/2019 08:59:00 -40.0 -44.5 17.9 17.9 - - 80 0 1
7/5/2019 09:00:00 -40.1 -44.5 17.9 17.8 - - 80 0 1
7/5/2019 09:01:00 -40.2 -44.5 17.9 17.8 - - 80 0 1
7/5/2019 09:02:00 -40.4 -44.5 17.9 17.8 - - 80 0 1
7/5/2019 09:03:00 -40.5 -44.5 17.9 17.8 - - 80 0 1
7/5/2019 09:04:00 -40.6 -44.5 17.9 17.8 - - 80 0 1
7/5/2019 09:05:00 -40.7 -44.5 17.9 17.8 - - 80 0 1
7/5/2019 09:06:00 -40.8 -44.5 17.9 17.7 - - 80 0 1
7/5/2019 09:07:00 -40.9 -44.5 17.8 17.7 - - 80 0 1
7/5/2019 09:08:00 -40.9 -44.5 17.9 17.7 - - 80 0 1
7/5/2019 09:08:04 Audit: - A_HTRFAIL ALARM is acknowledged by IDIN.
7/5/2019 09:09:00 -41.0 -44.5 17.8 17.7 - - 80 0 1
7/5/2019 09:10:00 -41.1 -44.5 17.8 17.7 - - 80 0 1
7/5/2019 09:11:00 -41.2 -44.5 17.8 17.7 - - 80 0 1
7/5/2019 09:12:00 -41.2 -44.5 17.8 17.7 - - 80 0 1
7/5/2019 09:13:00 -41.3 -44.5 17.7 17.7 - - 80 0 1
7/5/2019 09:14:00 -41.3 -44.5 17.7 17.6 - - 80 0 1
7/5/2019 09:15:00 -41.3 -44.5 17.7 17.6 - - 80 0 1
7/5/2019 09:16:00 -41.3 -44.5 17.7 17.6 - - 80 0 1

-------------------------------------------
Approved by Date Page: 43 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 09:17:00 -41.3 -44.5 17.7 17.6 - - 80 0 1
7/5/2019 09:18:00 -41.3 -44.5 17.7 17.6 - - 80 0 1
7/5/2019 09:19:00 -41.3 -44.5 17.7 17.6 - - 80 0 1
7/5/2019 09:20:00 -41.3 -44.5 17.7 17.6 - - 80 0 1
7/5/2019 09:21:00 -41.3 -44.5 17.6 17.6 - - 80 0 1
7/5/2019 09:22:00 -41.3 -44.5 17.6 17.6 - - 80 0 1
7/5/2019 09:23:00 -41.3 -44.5 17.6 17.5 - - 80 0 1
7/5/2019 09:24:00 -41.4 -44.5 17.6 17.5 - - 80 0 1
7/5/2019 09:25:00 -41.5 -44.5 17.6 17.5 - - 80 0 1
7/5/2019 09:26:00 -41.7 -44.5 17.6 17.5 - - 80 0 1
7/5/2019 09:27:00 -41.7 -44.5 17.6 17.5 - - 80 0 1
7/5/2019 09:28:00 -41.8 -44.5 17.6 17.5 - - 80 0 1
7/5/2019 09:29:00 -41.9 -44.5 17.5 17.4 - - 80 0 1
7/5/2019 09:30:00 -41.9 -44.5 17.5 17.5 - - 80 0 1
7/5/2019 09:31:00 -42.0 -44.5 17.5 17.4 - - 80 0 1
7/5/2019 09:32:00 -42.1 -44.5 17.5 17.4 - - 80 0 1
7/5/2019 09:33:00 -42.1 -44.5 17.5 17.4 - - 80 0 1
7/5/2019 09:34:00 -42.2 -44.5 17.5 17.4 - - 80 0 1
7/5/2019 09:35:00 -42.2 -44.5 17.5 17.4 - - 80 0 1
7/5/2019 09:36:00 -42.2 -44.5 17.5 17.4 - - 80 0 1
7/5/2019 09:37:00 -42.2 -44.5 17.5 17.4 - - 80 0 1
7/5/2019 09:38:00 -42.3 -44.5 17.4 17.3 - - 80 0 1
7/5/2019 09:39:00 -42.3 -44.5 17.4 17.4 - - 80 0 1
7/5/2019 09:40:00 -42.3 -44.5 17.4 17.3 - - 80 0 1
7/5/2019 09:41:00 -42.4 -44.5 17.4 17.3 - - 80 0 1
7/5/2019 09:42:00 -42.4 -44.5 17.4 17.3 - - 80 0 1
7/5/2019 09:43:00 -42.4 -44.5 17.3 17.3 - - 80 0 1

-------------------------------------------
Approved by Date Page: 44 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 09:44:00 -42.4 -44.5 17.4 17.3 - - 80 0 1
7/5/2019 09:45:00 -42.5 -44.5 17.3 17.3 - - 80 0 1
7/5/2019 09:46:00 -42.5 -44.5 17.3 17.3 - - 80 0 1
7/5/2019 09:47:00 -42.5 -44.5 17.3 17.2 - - 80 0 1
7/5/2019 09:48:00 -42.6 -44.5 17.3 17.2 - - 80 0 1
7/5/2019 09:49:00 -42.6 -44.5 17.3 17.2 - - 80 0 1
7/5/2019 09:50:00 -42.6 -44.5 17.3 17.2 - - 80 0 1
7/5/2019 09:51:00 -42.7 -44.5 17.2 17.2 - - 80 0 1
7/5/2019 09:52:00 -42.6 -44.5 17.2 17.2 - - 80 0 1
7/5/2019 09:53:00 -42.7 -44.5 17.2 17.2 - - 80 0 1
7/5/2019 09:54:00 -42.7 -44.5 17.2 17.1 - - 80 0 1
7/5/2019 09:55:00 -42.7 -44.5 17.2 17.1 - - 80 0 1
7/5/2019 09:56:00 -42.8 -44.5 17.2 17.1 - - 80 0 1
7/5/2019 09:57:00 -42.8 -44.5 17.2 17.1 - - 80 0 1
7/5/2019 09:58:00 -42.8 -44.5 17.2 17.1 - - 80 0 1
7/5/2019 09:59:00 -42.8 -44.5 17.2 17.1 - - 80 0 1
7/5/2019 10:00:00 -42.8 -44.5 17.1 17.1 - - 80 0 1
7/5/2019 10:01:00 -42.9 -44.5 17.1 17.1 - - 80 0 1
7/5/2019 10:02:00 -43.0 -44.5 17.1 17.1 - - 80 0 1
7/5/2019 10:03:00 -43.1 -44.5 17.1 17.1 - - 80 0 1
7/5/2019 10:04:00 -43.1 -44.5 17.1 17.0 - - 80 0 1
7/5/2019 10:05:00 -43.2 -44.5 17.1 17.0 - - 80 0 1
7/5/2019 10:06:00 -43.2 -44.5 17.1 17.0 - - 80 0 1
7/5/2019 10:07:00 -43.2 -44.5 17.1 17.0 - - 80 0 1
7/5/2019 10:08:00 -43.1 -44.5 17.1 17.0 - - 80 0 1
7/5/2019 10:09:00 -43.1 -44.5 17.0 17.0 - - 80 0 1
7/5/2019 10:10:00 -43.1 -44.5 17.0 17.0 - - 80 0 1

-------------------------------------------
Approved by Date Page: 45 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 10:11:00 -43.1 -44.5 17.0 17.0 - - 80 0 1
7/5/2019 10:12:00 -43.3 -44.5 17.0 16.9 - - 80 0 1
7/5/2019 10:13:00 -43.3 -44.5 17.0 17.0 - - 80 0 1
7/5/2019 10:14:00 -43.3 -44.5 17.0 16.9 - - 80 0 1
7/5/2019 10:15:00 -43.3 -44.5 17.0 16.9 - - 80 0 1
7/5/2019 10:16:00 -43.3 -44.5 17.0 16.9 - - 80 0 1
7/5/2019 10:17:00 -43.3 -44.5 16.9 16.9 - - 80 0 1
7/5/2019 10:18:00 -43.3 -44.5 16.9 16.8 - - 80 0 1
7/5/2019 10:19:00 -43.4 -44.5 16.9 16.8 - - 80 0 1
7/5/2019 10:20:00 -43.4 -44.5 16.9 16.8 - - 80 0 1
7/5/2019 10:21:00 -43.4 -44.5 16.8 16.8 - - 80 0 1
7/5/2019 10:22:00 -43.4 -44.5 16.9 16.8 - - 80 0 1
7/5/2019 10:23:00 -43.3 -44.5 16.8 16.8 - - 80 0 1
7/5/2019 10:24:00 -43.3 -44.5 16.8 16.8 - - 80 0 1
7/5/2019 10:25:00 -43.3 -44.5 16.8 16.8 - - 80 0 1
7/5/2019 10:26:00 -43.4 -44.5 16.8 16.8 - - 80 0 1
7/5/2019 10:27:00 -43.3 -44.5 16.8 16.7 - - 80 0 1
7/5/2019 10:28:00 -43.3 -44.5 16.8 16.7 - - 80 0 1
7/5/2019 10:29:00 -43.4 -44.5 16.8 16.7 - - 80 0 1
7/5/2019 10:30:00 -43.3 -44.5 16.8 16.7 - - 80 0 1
7/5/2019 10:31:00 -43.4 -44.5 16.8 16.7 - - 80 0 1
7/5/2019 10:32:00 -43.3 -44.5 16.8 16.7 - - 80 0 1
7/5/2019 10:33:00 -43.3 -44.5 16.8 16.7 - - 80 0 1
7/5/2019 10:34:00 -43.3 -44.5 16.8 16.6 - - 80 0 1
7/5/2019 10:35:00 -43.4 -44.5 16.7 16.7 - - 80 0 1
7/5/2019 10:36:00 -43.3 -44.5 16.7 16.6 - - 80 0 1
7/5/2019 10:37:00 -43.2 -44.5 16.7 16.6 - - 80 0 1

-------------------------------------------
Approved by Date Page: 46 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 10:38:00 -43.1 -44.5 16.7 16.6 - - 80 0 1
7/5/2019 10:39:00 -43.1 -44.5 16.6 16.6 - - 80 0 1
7/5/2019 10:40:00 -43.1 -44.5 16.6 16.6 - - 80 0 1
7/5/2019 10:41:00 -43.1 -44.5 16.6 16.6 - - 80 0 1
7/5/2019 10:42:00 -43.1 -44.5 16.6 16.5 - - 80 0 1
7/5/2019 10:43:00 -43.0 -44.5 16.6 16.5 - - 80 0 1
7/5/2019 10:44:00 -43.0 -44.5 16.6 16.5 - - 80 0 1
7/5/2019 10:45:00 -42.9 -44.5 16.6 16.5 - - 80 0 1
7/5/2019 10:46:00 -43.0 -44.5 16.5 16.5 - - 80 0 1
7/5/2019 10:47:00 -42.9 -44.5 16.6 16.5 - - 80 0 1
7/5/2019 10:48:00 -43.0 -44.5 16.5 16.5 - - 80 0 1
7/5/2019 10:49:00 -43.0 -44.5 16.5 16.5 - - 80 0 1
7/5/2019 10:50:00 -43.1 -44.5 16.5 16.5 - - 80 0 1
7/5/2019 10:51:00 -43.1 -44.5 16.5 16.4 - - 80 0 1
7/5/2019 10:52:00 -43.1 -44.5 16.5 16.4 - - 80 0 1
7/5/2019 10:53:00 -43.2 -44.5 16.5 16.4 - - 80 0 1
7/5/2019 10:54:00 -43.2 -44.5 16.5 16.4 - - 80 0 1
7/5/2019 10:55:00 -43.2 -44.5 16.5 16.4 - - 80 0 1
7/5/2019 10:56:00 -43.2 -44.5 16.4 16.4 - - 80 0 1
7/5/2019 10:57:00 -43.2 -44.5 16.4 16.4 - - 80 0 1
7/5/2019 10:58:00 -43.3 -44.5 16.4 16.3 - - 80 0 1
7/5/2019 10:59:00 -42.2 -44.5 16.4 16.3 - - 80 0 1
7/5/2019 11:00:00 -42.1 -44.5 16.4 16.3 - - 80 0 1
7/5/2019 11:01:00 -42.2 -44.5 16.4 16.3 - - 80 0 1
7/5/2019 11:02:00 -42.5 -44.5 16.4 16.3 - - 80 0 1
7/5/2019 11:03:00 -42.6 -44.5 16.3 16.3 - - 80 0 1
7/5/2019 11:04:00 -42.6 -44.5 16.3 16.3 - - 80 0 1

-------------------------------------------
Approved by Date Page: 47 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 11:05:00 -42.6 -44.5 16.3 16.3 - - 80 0 1
7/5/2019 11:06:00 -42.5 -44.5 16.3 16.3 - - 80 0 1
7/5/2019 11:07:00 -42.5 -44.5 16.3 16.3 - - 80 0 1
7/5/2019 11:08:00 -42.5 -44.5 16.3 16.2 - - 80 0 1
7/5/2019 11:09:00 -42.5 -44.5 16.3 16.2 - - 80 0 1
7/5/2019 11:10:00 -42.4 -44.5 16.3 16.2 - - 80 0 1
7/5/2019 11:11:00 -42.4 -44.5 16.3 16.2 - - 80 0 1
7/5/2019 11:12:00 -42.3 -44.5 16.3 16.2 - - 80 0 1
7/5/2019 11:13:00 -42.4 -44.5 16.2 16.2 - - 80 0 1
7/5/2019 11:14:00 -42.4 -44.5 16.2 16.1 - - 80 0 1
7/5/2019 11:15:00 -42.4 -44.5 16.2 16.2 - - 80 0 1
7/5/2019 11:16:00 -42.8 -44.5 16.2 16.1 - - 80 0 1
7/5/2019 11:17:00 -42.7 -44.5 16.2 16.1 - - 80 0 1
7/5/2019 11:18:00 -42.7 -44.5 16.2 16.1 - - 80 0 1
7/5/2019 11:19:00 -42.7 -44.5 16.2 16.1 - - 80 0 1
7/5/2019 11:20:00 -42.7 -44.5 16.1 16.0 - - 80 0 1
7/5/2019 11:21:00 -42.8 -44.5 16.1 16.1 - - 80 0 1
7/5/2019 11:22:00 -42.8 -44.5 16.1 16.0 - - 80 0 1
7/5/2019 11:23:00 -42.9 -44.5 16.1 16.0 - - 80 0 1
7/5/2019 11:24:00 -43.0 -44.5 16.1 16.0 - - 80 0 1
7/5/2019 11:25:00 -43.0 -44.5 16.1 16.0 - - 80 0 1
7/5/2019 11:26:00 -43.0 -44.5 16.0 16.0 - - 80 0 1
7/5/2019 11:27:00 -43.2 -44.5 16.0 16.0 - - 80 0 1
7/5/2019 11:28:00 -43.1 -44.5 16.0 16.0 - - 80 0 1
7/5/2019 11:29:00 -43.1 -44.5 16.0 16.0 - - 80 0 1
7/5/2019 11:30:00 -43.1 -44.5 16.0 16.0 - - 80 0 1
7/5/2019 11:31:00 -43.0 -44.5 16.0 16.0 - - 80 0 1

-------------------------------------------
Approved by Date Page: 48 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 11:32:00 -43.0 -44.5 16.0 15.9 - - 80 0 1
7/5/2019 11:33:00 -43.1 -44.5 16.0 15.9 - - 80 0 1
7/5/2019 11:34:00 -43.0 -44.5 16.0 15.9 - - 80 0 1
7/5/2019 11:35:00 -42.9 -44.5 16.0 15.9 - - 80 0 1
7/5/2019 11:36:00 -42.8 -44.5 16.0 15.9 - - 80 0 1
7/5/2019 11:37:00 -42.9 -44.5 15.9 15.8 - - 80 0 1
7/5/2019 11:37:35 Event: - Auto freeze cycle hold mode exited.
7/5/2019 11:38:00 -43.5 -44.8 15.9 15.9 - - 80 0 1
7/5/2019 11:38:30 Event: - Auto freeze cycle hold mode activated.
7/5/2019 11:39:00 -43.9 -45.0 15.9 15.9 - - 80 0 1
7/5/2019 11:40:00 -44.0 -45.0 15.9 15.8 - - 80 0 1
7/5/2019 11:40:10 Event: - Step advanced to [4] Freezing
7/5/2019 11:40:15 Event: - Auto freeze cycle hold mode exited.
7/5/2019 11:41:00 -44.2 -45.0 15.9 15.8 - - 80 0 1
7/5/2019 11:41:40 Audit: - Trend.grpDuration.strDuration.CurrentValue set to 2 by IDIN.
7/5/2019 11:41:43 Audit: - Trend.grpDuration.strDuration.CurrentValue set to 3 by IDIN.
7/5/2019 11:42:00 -44.3 -45.0 15.9 15.8 - - 80 0 1
7/5/2019 11:43:00 -44.6 -45.0 15.8 15.8 - - 80 0 1
7/5/2019 11:44:00 -44.7 -45.0 15.8 15.8 - - 80 0 1
7/5/2019 11:45:00 -44.8 -45.0 15.8 15.8 - - 80 0 1
7/5/2019 11:46:00 -44.9 -45.0 15.8 15.8 - - 80 0 1
7/5/2019 11:47:00 -45.0 -45.0 15.8 15.8 - - 80 0 1
7/5/2019 11:48:00 -45.2 -45.0 15.8 15.8 - - 80 0 1
7/5/2019 11:49:00 -45.4 -45.0 15.8 15.8 - - 80 0 1
7/5/2019 11:50:00 -45.5 -45.0 15.8 15.7 - - 80 0 1
7/5/2019 11:51:00 -45.6 -45.0 15.7 15.7 - - 80 0 1
7/5/2019 11:52:00 -45.7 -45.0 15.8 15.7 - - 80 0 1

-------------------------------------------
Approved by Date Page: 49 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 11:53:00 -45.5 -45.0 15.7 15.7 - - 80 0 1
7/5/2019 11:54:00 -45.3 -45.0 15.7 15.7 - - 80 0 1
7/5/2019 11:55:00 -45.1 -45.0 15.7 15.7 - - 80 0 1
7/5/2019 11:56:00 -45.1 -45.0 15.7 15.7 - - 80 0 1
7/5/2019 11:57:00 -45.0 -45.0 15.7 15.7 - - 80 0 1
7/5/2019 11:58:00 -44.9 -45.0 15.7 15.7 - - 80 0 1
7/5/2019 11:59:00 -44.9 -45.0 15.7 15.7 - - 80 0 1
7/5/2019 12:00:00 -44.9 -45.0 15.6 15.6 - - 80 0 1
7/5/2019 12:01:00 -44.8 -45.0 15.7 15.6 - - 80 0 1
7/5/2019 12:02:00 -44.8 -45.0 15.6 15.6 - - 80 0 1
7/5/2019 12:03:00 -44.7 -45.0 15.6 15.6 - - 80 0 1
7/5/2019 12:04:00 -44.7 -45.0 15.6 15.6 - - 80 0 1
7/5/2019 12:05:00 -44.9 -45.0 15.6 15.6 - - 80 0 1
7/5/2019 12:06:00 -44.7 -45.0 15.6 15.6 - - 80 0 1
7/5/2019 12:07:00 -45.0 -45.0 15.6 15.5 - - 80 0 1
7/5/2019 12:08:00 -45.0 -45.0 15.6 15.5 - - 80 0 1
7/5/2019 12:09:00 -44.9 -45.0 15.5 15.5 - - 80 0 1
7/5/2019 12:10:00 -45.1 -45.0 15.5 15.5 - - 80 0 1
7/5/2019 12:11:00 -45.2 -45.0 15.5 15.4 - - 80 0 1
7/5/2019 12:12:00 -45.0 -45.0 15.5 15.5 - - 80 0 1
7/5/2019 12:13:00 -45.1 -45.0 15.5 15.5 - - 80 0 1
7/5/2019 12:14:00 -45.2 -45.0 15.5 15.4 - - 80 0 1
7/5/2019 12:15:00 -45.2 -45.0 15.5 15.4 - - 80 0 1
7/5/2019 12:16:00 -45.0 -45.0 15.5 15.4 - - 80 0 1
7/5/2019 12:17:00 -45.0 -45.0 15.4 15.4 - - 80 0 1
7/5/2019 12:18:00 -45.2 -45.0 15.5 15.4 - - 80 0 1
7/5/2019 12:19:00 -44.9 -45.0 15.4 15.4 - - 80 0 1

-------------------------------------------
Approved by Date Page: 50 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 12:20:00 -45.0 -45.0 15.4 15.4 - - 80 0 1
7/5/2019 12:21:00 -45.1 -45.0 15.4 15.4 - - 80 0 1
7/5/2019 12:22:00 -44.9 -45.0 15.4 15.4 - - 80 0 1
7/5/2019 12:23:00 -45.0 -45.0 15.4 15.4 - - 80 0 1
7/5/2019 12:24:00 -45.1 -45.0 15.4 15.4 - - 80 0 1
7/5/2019 12:25:00 -44.9 -45.0 15.4 15.4 - - 80 0 1
7/5/2019 12:26:00 -44.9 -45.0 15.4 15.4 - - 80 0 1
7/5/2019 12:27:00 -45.1 -45.0 15.4 15.3 - - 80 0 1
7/5/2019 12:28:00 -44.9 -45.0 15.3 15.3 - - 80 0 1
7/5/2019 12:29:00 -45.0 -45.0 15.4 15.3 - - 80 0 1
7/5/2019 12:30:00 -45.2 -45.0 15.3 15.3 - - 80 0 1
7/5/2019 12:31:00 -45.0 -45.0 15.3 15.3 - - 80 0 1
7/5/2019 12:32:00 -45.0 -45.0 15.3 15.3 - - 80 0 1
7/5/2019 12:33:00 -45.0 -45.0 15.3 15.3 - - 80 0 1
7/5/2019 12:34:00 -45.1 -45.0 15.3 15.2 - - 80 0 1
7/5/2019 12:35:00 -44.9 -45.0 15.3 15.3 - - 80 0 1
7/5/2019 12:36:00 -44.9 -45.0 15.3 15.2 - - 80 0 1
7/5/2019 12:37:00 -45.0 -45.0 15.2 15.2 - - 80 0 1
7/5/2019 12:38:00 -44.9 -45.0 15.2 15.2 - - 80 0 1
7/5/2019 12:39:00 -45.1 -45.0 15.2 15.2 - - 80 0 1
7/5/2019 12:40:00 -45.0 -45.0 15.2 15.2 - - 80 0 1
7/5/2019 12:41:00 -44.9 -45.0 15.2 15.2 - - 80 0 1
7/5/2019 12:42:00 -45.1 -45.0 15.2 15.2 - - 80 0 1
7/5/2019 12:43:00 -45.1 -45.0 15.2 15.2 - - 80 0 1
7/5/2019 12:44:00 -45.0 -45.0 15.2 15.1 - - 80 0 1
7/5/2019 12:45:00 -45.1 -45.0 15.2 15.1 - - 80 0 1
7/5/2019 12:46:00 -45.1 -45.0 15.2 15.1 - - 80 0 1

-------------------------------------------
Approved by Date Page: 51 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 12:47:00 -44.9 -45.0 15.1 15.1 - - 80 0 1
7/5/2019 12:48:00 -45.0 -45.0 15.1 15.1 - - 80 0 1
7/5/2019 12:49:00 -45.1 -45.0 15.1 15.1 - - 80 0 1
7/5/2019 12:50:00 -44.9 -45.0 15.1 15.1 - - 80 0 1
7/5/2019 12:51:00 -44.9 -45.0 15.1 15.1 - - 80 0 1
7/5/2019 12:52:00 -45.2 -45.0 15.1 15.1 - - 80 0 1
7/5/2019 12:53:00 -45.1 -45.0 15.1 15.1 - - 80 0 1
7/5/2019 12:54:00 -45.0 -45.0 15.1 15.1 - - 80 0 1
7/5/2019 12:55:00 -45.1 -45.0 15.1 15.1 - - 80 0 1
7/5/2019 12:56:00 -45.1 -45.0 15.1 15.1 - - 80 0 1
7/5/2019 12:57:00 -44.9 -45.0 15.0 15.0 - - 80 0 1
7/5/2019 12:58:00 -45.0 -45.0 15.0 15.0 - - 80 0 1
7/5/2019 12:59:00 -45.1 -45.0 15.0 15.0 - - 80 0 1
7/5/2019 13:00:00 -44.9 -45.0 15.0 15.0 - - 80 0 1
7/5/2019 13:01:00 -45.0 -45.0 15.0 15.0 - - 80 0 1
7/5/2019 13:02:00 -45.1 -45.0 15.0 15.0 - - 80 0 1
7/5/2019 13:03:00 -44.9 -45.0 15.0 14.9 - - 80 0 1
7/5/2019 13:04:00 -45.0 -45.0 14.9 14.9 - - 80 0 1
7/5/2019 13:05:00 -45.2 -45.0 14.9 14.9 - - 80 0 1
7/5/2019 13:06:00 -45.0 -45.0 14.9 14.9 - - 80 0 1
7/5/2019 13:07:00 -45.0 -45.0 14.9 14.9 - - 80 0 1
7/5/2019 13:08:00 -45.0 -45.0 14.9 14.9 - - 80 0 1
7/5/2019 13:09:00 -44.9 -45.0 14.9 14.9 - - 80 0 1
7/5/2019 13:10:00 -44.9 -45.0 14.9 14.9 - - 80 0 1
7/5/2019 13:10:05 Event: - Step advanced to [5] Evacuation
7/5/2019 13:11:00 -44.9 -45.0 14.9 14.9 - 200 230 170 1
7/5/2019 13:12:00 -44.2 -45.0 14.9 14.8 - 200 230 170 1

-------------------------------------------
Approved by Date Page: 52 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 13:13:00 -44.0 -45.0 14.5 13.6 - 200 230 170 1
7/5/2019 13:14:00 -44.4 -45.0 13.7 8.5 - 200 230 170 1
7/5/2019 13:15:00 -43.8 -45.0 12.3 -9.0 - 200 230 170 1
7/5/2019 13:16:00 -43.3 -45.0 10.6 -31.7 - 200 230 170 1
7/5/2019 13:16:50 Event: - The condenser is cooled to -40°C.
7/5/2019 13:17:00 -43.1 -45.0 8.8 -41.7 - 200 230 170 1
7/5/2019 13:18:00 -42.8 -45.0 7.2 -46.5 - 200 230 170 1
7/5/2019 13:19:00 -42.5 -45.0 5.7 -48.8 - 200 230 170 1
7/5/2019 13:20:00 -42.3 -45.0 4.3 -50.4 - 200 230 170 1
7/5/2019 13:21:00 -42.2 -45.0 3.0 -51.1 - 200 230 170 1
7/5/2019 13:22:00 -42.0 -45.0 1.8 -50.8 - 200 230 170 1
7/5/2019 13:23:00 -41.8 -45.0 0.7 -50.4 - 200 230 170 1
7/5/2019 13:24:00 -41.8 -45.0 -0.4 -50.2 - 200 230 170 1
7/5/2019 13:25:00 -41.6 -45.0 -1.4 -50.2 - 200 230 170 1
7/5/2019 13:26:00 -41.4 -45.0 -2.5 -50.5 - 200 230 170 1
7/5/2019 13:27:00 -41.7 -45.0 -3.4 -50.4 - 200 230 170 1
7/5/2019 13:27:55 Event: - The evacuation is started.
7/5/2019 13:28:00 -42.3 -45.0 -4.0 -48.4 - 200 230 170 -
7/5/2019 13:29:00 -42.3 -45.0 -5.3 -45.8 - 200 230 170 -
7/5/2019 13:30:00 -41.8 -45.0 -6.3 -43.6 - 200 230 170 -
7/5/2019 13:31:00 -42.9 -45.0 -7.1 -41.8 - 200 230 170 -
7/5/2019 13:32:00 -42.7 -45.0 -7.8 -40.1 - 200 230 170 -
7/5/2019 13:33:00 -42.7 -45.0 -8.3 -38.7 - 200 230 170 -
7/5/2019 13:34:00 -42.8 -45.0 -8.6 -37.5 - 200 230 170 -
7/5/2019 13:35:00 -42.9 -45.0 -8.9 -36.5 - 200 230 170 -
7/5/2019 13:36:00 -43.0 -45.0 -9.0 -35.8 - 200 230 170 -
7/5/2019 13:37:00 -43.0 -45.0 -9.2 -35.2 - 200 230 170 -

-------------------------------------------
Approved by Date Page: 53 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 13:38:00 -43.1 -45.0 -9.8 -34.6 - 200 230 170 -
7/5/2019 13:39:00 -43.2 -45.0 -11.1 -34.2 - 200 230 170 -
7/5/2019 13:40:00 -43.3 -45.0 -13.3 -33.9 - 200 230 170 -
7/5/2019 13:41:00 -43.4 -45.0 -27.9 -33.6 - 200 230 170 -
7/5/2019 13:42:00 -43.4 -45.0 -39.9 -33.4 - 200 230 170 -
7/5/2019 13:43:00 -43.5 -45.0 -46.0 -33.2 - 200 230 170 -
7/5/2019 13:44:00 -43.5 -45.0 -49.5 -33.1 517 200 230 170 623
7/5/2019 13:45:00 -43.6 -45.0 -51.0 -32.9 286 200 230 170 325
7/5/2019 13:46:00 -43.6 -45.0 -52.3 -32.7 178 200 230 170 188
7/5/2019 13:47:00 -43.7 -45.0 -53.2 -32.6 125 200 230 170 120
7/5/2019 13:48:00 -43.8 -45.0 -53.5 -32.4 99 200 230 170 87
7/5/2019 13:49:00 -43.9 -45.0 -53.4 -32.3 92 200 230 170 77
7/5/2019 13:50:00 -44.0 -45.0 -50.3 -32.2 89 200 230 170 80
7/5/2019 13:50:35 Event: - Step advanced to [6] Drying
7/5/2019 13:51:00 -44.1 -43.9 -47.6 -32.0 197 200 230 170 214
7/5/2019 13:52:00 -44.1 -43.4 -46.7 -31.9 199 200 230 170 219
7/5/2019 13:53:00 -44.2 -42.9 -46.1 -31.7 200 200 230 170 219
7/5/2019 13:54:00 -44.1 -42.4 -45.9 -31.6 200 200 230 170 219
7/5/2019 13:55:00 -43.7 -41.9 -45.9 -31.2 200 200 230 170 217
7/5/2019 13:56:00 -42.9 -41.4 -46.7 -32.2 200 200 230 170 214
7/5/2019 13:57:00 -41.8 -40.9 -48.1 -44.7 200 200 230 170 208
7/5/2019 13:58:00 -40.8 -40.4 -49.1 -53.3 200 200 230 170 205
7/5/2019 13:59:00 -40.0 -39.9 -49.3 -58.0 200 200 230 170 203
7/5/2019 14:00:00 -39.2 -39.4 -49.0 -60.7 200 200 230 170 202
7/5/2019 14:01:00 -38.6 -38.9 -48.7 -62.9 200 200 230 170 202
7/5/2019 14:02:00 -38.2 -38.5 -48.5 -64.7 200 200 230 170 200
7/5/2019 14:03:00 -37.9 -38.0 -48.3 -66.3 199 200 230 170 200

-------------------------------------------
Approved by Date Page: 54 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 14:04:00 -37.5 -37.5 -48.2 -67.6 200 200 230 170 200
7/5/2019 14:05:00 -37.2 -37.0 -50.9 -68.6 200 200 230 170 200
7/5/2019 14:06:00 -36.7 -36.5 -53.1 -69.5 200 200 230 170 200
7/5/2019 14:07:00 -36.1 -36.0 -54.0 -70.3 200 200 230 170 200
7/5/2019 14:08:00 -35.6 -35.5 -54.5 -70.9 200 200 230 170 202
7/5/2019 14:09:00 -35.0 -35.0 -54.7 -71.6 202 200 230 170 200
7/5/2019 14:10:00 -34.5 -34.5 -54.8 -72.1 200 200 230 170 200
7/5/2019 14:11:00 -34.0 -34.0 -54.8 -72.5 200 200 230 170 199
7/5/2019 14:12:00 -33.5 -33.5 -55.0 -72.9 200 200 230 170 200
7/5/2019 14:13:00 -33.0 -33.1 -55.2 -73.2 200 200 230 170 200
7/5/2019 14:14:00 -32.5 -32.6 -55.3 -73.4 200 200 230 170 199
7/5/2019 14:15:00 -32.1 -32.1 -55.5 -73.7 199 200 230 170 199
7/5/2019 14:16:00 -31.7 -31.6 -55.8 -73.9 200 200 230 170 199
7/5/2019 14:17:00 -31.2 -31.1 -56.0 -74.1 200 200 230 170 198
7/5/2019 14:18:00 -30.6 -30.6 -56.2 -74.2 199 200 230 170 198
7/5/2019 14:19:00 -30.1 -30.1 -56.2 -74.3 200 200 230 170 198
7/5/2019 14:20:00 -29.6 -29.6 -56.0 -74.3 202 200 230 170 199
7/5/2019 14:21:00 -29.1 -29.1 -55.7 -74.2 199 200 230 170 198
7/5/2019 14:22:00 -28.6 -28.6 -55.8 -74.0 199 200 230 170 195
7/5/2019 14:23:00 -28.1 -28.1 -55.6 -73.8 195 200 230 170 192
7/5/2019 14:24:00 -27.6 -27.7 -55.6 -73.6 197 200 230 170 195
7/5/2019 14:25:00 -27.1 -27.2 -55.5 -73.2 197 200 230 170 195
7/5/2019 14:26:00 -26.7 -26.7 -55.5 -72.8 199 200 230 170 196
7/5/2019 14:27:00 -26.2 -26.2 -55.7 -72.5 199 200 230 170 196
7/5/2019 14:28:00 -25.8 -25.7 -55.6 -72.3 198 200 230 170 196
7/5/2019 14:29:00 -25.2 -25.2 -55.4 -72.2 199 200 230 170 196
7/5/2019 14:30:00 -24.7 -24.7 -55.4 -72.1 198 200 230 170 195

-------------------------------------------
Approved by Date Page: 55 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 14:31:00 -24.2 -24.2 -55.7 -71.9 199 200 230 170 196
7/5/2019 14:32:00 -23.7 -23.7 -56.1 -71.5 199 200 230 170 195
7/5/2019 14:33:00 -23.2 -23.2 -56.5 -71.0 199 200 230 170 196
7/5/2019 14:34:00 -22.8 -22.7 -56.8 -70.7 199 200 230 170 196
7/5/2019 14:35:00 -22.3 -22.3 -56.9 -70.4 199 200 230 170 197
7/5/2019 14:36:00 -21.8 -21.8 -56.5 -70.3 202 200 230 170 198
7/5/2019 14:37:00 -21.3 -21.3 -56.3 -70.1 202 200 230 170 199
7/5/2019 14:38:00 -20.8 -20.8 -56.3 -69.9 203 200 230 170 199
7/5/2019 14:39:00 -20.3 -20.3 -56.4 -69.6 204 200 230 170 199
7/5/2019 14:40:00 -19.8 -19.8 -56.4 -69.4 201 200 230 170 197
7/5/2019 14:41:00 -19.3 -19.3 -57.0 -69.1 199 200 230 170 195
7/5/2019 14:42:00 -18.8 -18.8 -57.6 -68.9 197 200 230 170 195
7/5/2019 14:43:00 -18.4 -18.3 -57.8 -68.8 199 200 230 170 196
7/5/2019 14:44:00 -17.9 -17.8 -58.0 -68.7 199 200 230 170 198
7/5/2019 14:45:00 -17.4 -17.3 -58.3 -68.5 202 200 230 170 201
7/5/2019 14:46:00 -16.9 -16.8 -58.5 -68.0 199 200 230 170 201
7/5/2019 14:47:00 -16.4 -16.4 -58.8 -67.5 200 200 230 170 203
7/5/2019 14:48:00 -15.9 -15.9 -58.9 -67.0 200 200 230 170 205
7/5/2019 14:49:00 -15.4 -15.4 -58.9 -66.4 200 200 230 170 207
7/5/2019 14:50:00 -14.9 -14.9 -58.6 -65.9 200 200 230 170 207
7/5/2019 14:51:00 -14.4 -14.4 -58.4 -65.5 200 200 230 170 210
7/5/2019 14:52:00 -13.9 -13.9 -58.0 -65.0 201 200 230 170 211
7/5/2019 14:53:00 -13.5 -13.4 -57.3 -64.5 200 200 230 170 214
7/5/2019 14:54:00 -13.0 -12.9 -56.5 -63.8 200 200 230 170 215
7/5/2019 14:55:00 -12.5 -12.4 -55.5 -62.9 200 200 230 170 217
7/5/2019 14:56:00 -12.0 -11.9 -54.4 -61.8 200 200 230 170 220
7/5/2019 14:57:00 -11.5 -11.4 -53.4 -60.3 202 200 230 170 221

-------------------------------------------
Approved by Date Page: 56 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 14:58:00 -11.0 -11.0 -52.2 -58.3 200 200 230 170 224
7/5/2019 14:59:00 -10.5 -10.5 -51.2 -57.6 200 200 230 170 225
7/5/2019 15:00:00 -10.0 -10.0 -50.1 -57.9 202 200 230 170 226
7/5/2019 15:01:00 -9.5 -9.5 -49.1 -57.3 200 200 230 170 228
7/5/2019 15:02:00 -9.1 -9.0 -48.1 -56.3 200 200 230 170 229
7/5/2019 15:03:00 -8.6 -8.5 -47.2 -55.9 200 200 230 170 232
7/5/2019 15:04:00 -8.1 -8.0 -46.6 -56.0 200 200 230 170 232
7/5/2019 15:05:00 -7.7 -7.5 -46.0 -56.3 202 200 230 170 233
7/5/2019 15:06:00 -7.2 -7.0 -46.0 -56.7 200 200 230 170 232
7/5/2019 15:07:00 -6.7 -6.5 -46.1 -57.1 200 200 230 170 233
7/5/2019 15:08:00 -6.2 -6.0 -46.3 -57.3 200 200 230 170 233
7/5/2019 15:09:00 -5.8 -5.6 -46.2 -57.1 200 200 230 170 234
7/5/2019 15:10:00 -5.3 -5.1 -46.1 -56.8 202 200 230 170 234
7/5/2019 15:11:00 -4.7 -4.6 -46.1 -56.5 202 200 230 170 234
7/5/2019 15:12:00 -4.2 -4.1 -47.0 -56.6 202 200 230 170 233
7/5/2019 15:13:00 -3.7 -3.6 -48.1 -57.1 200 200 230 170 230
7/5/2019 15:14:00 -3.2 -3.1 -48.5 -57.5 199 200 230 170 229
7/5/2019 15:15:00 -2.7 -2.6 -48.8 -57.2 200 200 230 170 233
7/5/2019 15:16:00 -2.2 -2.1 -48.8 -56.3 200 200 230 170 230
7/5/2019 15:17:00 -1.7 -1.6 -48.8 -55.6 200 200 230 170 232
7/5/2019 15:18:00 -1.2 -1.1 -48.7 -55.4 200 200 230 170 232
7/5/2019 15:19:00 -0.7 -0.6 -48.7 -55.7 200 200 230 170 228
7/5/2019 15:20:00 -0.2 -0.2 -48.7 -55.9 200 200 230 170 229
7/5/2019 15:21:00 0.3 0.3 -49.0 -55.9 200 200 230 170 228
7/5/2019 15:22:00 0.8 0.8 -49.0 -55.8 199 200 230 170 225
7/5/2019 15:23:00 1.3 1.3 -48.8 -55.4 202 200 230 170 230
7/5/2019 15:24:00 1.7 1.8 -48.5 -55.0 200 200 230 170 225

-------------------------------------------
Approved by Date Page: 57 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 15:25:00 2.2 2.3 -48.1 -54.8 200 200 230 170 225
7/5/2019 15:26:00 2.7 2.8 -47.9 -54.8 202 200 230 170 226
7/5/2019 15:27:00 3.2 3.3 -48.0 -54.7 199 200 230 170 222
7/5/2019 15:28:00 3.7 3.8 -47.8 -54.5 199 200 230 170 222
7/5/2019 15:29:00 4.1 4.3 -47.6 -54.2 202 200 230 170 226
7/5/2019 15:30:00 4.6 4.8 -47.3 -53.9 200 200 230 170 222
7/5/2019 15:30:30 Event: - Step advanced to [7] Drying
7/5/2019 15:31:00 5.2 5.0 -46.9 -53.5 199 200 230 170 221
7/5/2019 15:32:00 5.6 5.0 -46.5 -53.3 202 200 230 170 224
7/5/2019 15:33:00 5.7 5.0 -45.9 -53.1 200 200 230 170 220
7/5/2019 15:34:00 5.6 5.0 -45.7 -53.0 200 200 230 170 220
7/5/2019 15:35:00 5.3 5.0 -45.4 -52.8 202 200 230 170 222
7/5/2019 15:36:00 5.0 5.0 -45.1 -52.7 199 200 230 170 218
7/5/2019 15:37:00 4.8 5.0 -44.8 -52.5 199 200 230 170 220
7/5/2019 15:38:00 4.7 5.0 -44.6 -52.4 202 200 230 170 224
7/5/2019 15:39:00 4.8 5.0 -44.8 -52.3 200 200 230 170 222
7/5/2019 15:40:00 4.8 5.0 -45.0 -52.3 199 200 230 170 220
7/5/2019 15:41:00 5.0 5.0 -45.3 -52.5 200 200 230 170 222
7/5/2019 15:42:00 5.1 5.0 -45.4 -52.6 202 200 230 170 225
7/5/2019 15:43:00 5.1 5.0 -45.5 -52.7 200 200 230 170 222
7/5/2019 15:44:00 5.1 5.0 -45.5 -52.7 200 200 230 170 221
7/5/2019 15:45:00 5.1 5.0 -45.4 -52.7 199 200 230 170 220
7/5/2019 15:46:00 5.0 5.0 -45.4 -52.6 199 200 230 170 220
7/5/2019 15:47:00 5.0 5.0 -45.5 -52.7 200 200 230 170 221
7/5/2019 15:48:00 5.0 5.0 -45.5 -52.7 200 200 230 170 224
7/5/2019 15:49:00 5.0 5.0 -45.6 -52.8 202 200 230 170 224
7/5/2019 15:50:00 4.9 5.0 -45.6 -52.8 200 200 230 170 224

-------------------------------------------
Approved by Date Page: 58 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 15:51:00 4.9 5.0 -45.6 -52.8 200 200 230 170 222
7/5/2019 15:51:49 Audit: - Trend.grpDuration.strDuration.CurrentValue set to 10 by IDIN.
7/5/2019 15:52:00 5.0 5.0 -45.7 -52.8 200 200 230 170 222
7/5/2019 15:53:00 5.0 5.0 -45.6 -52.8 200 200 230 170 221
7/5/2019 15:54:00 5.0 5.0 -45.7 -52.8 199 200 230 170 220
7/5/2019 15:54:21 Audit: - Trend.grpDuration.strDuration.CurrentValue set to 3 by IDIN.
7/5/2019 15:54:53 Audit: - Trend.grpDuration.strDuration.CurrentValue set to 10 by IDIN.
7/5/2019 15:55:00 5.0 5.0 -45.7 -52.9 199 200 230 170 220
7/5/2019 15:56:00 5.1 5.0 -45.7 -52.9 199 200 230 170 220
7/5/2019 15:57:00 5.0 5.0 -45.7 -52.9 199 200 230 170 220
7/5/2019 15:58:00 5.0 5.0 -45.6 -52.9 199 200 230 170 220
7/5/2019 15:58:31 Audit: - Trend.grpDuration.strDuration.CurrentValue set to 3 by IDIN.
7/5/2019 15:59:00 5.0 5.0 -45.6 -52.8 199 200 230 170 220
7/5/2019 16:00:00 5.0 5.0 -45.5 -52.8 199 200 230 170 221
7/5/2019 16:01:00 5.0 5.0 -45.5 -52.8 200 200 230 170 221
7/5/2019 16:02:00 5.0 5.0 -45.5 -52.8 200 200 230 170 222
7/5/2019 16:03:00 5.0 5.0 -45.6 -52.8 200 200 230 170 222
7/5/2019 16:04:00 5.0 5.0 -45.5 -52.8 200 200 230 170 224
7/5/2019 16:05:00 5.0 5.0 -45.4 -52.8 202 200 230 170 225
7/5/2019 16:06:00 5.0 5.0 -45.1 -52.8 202 200 230 170 225
7/5/2019 16:07:00 5.0 5.0 -45.0 -52.7 202 200 230 170 225
7/5/2019 16:08:00 5.0 5.0 -45.0 -52.7 202 200 230 170 224
7/5/2019 16:09:00 5.0 5.0 -45.0 -52.7 201 200 230 170 224
7/5/2019 16:10:00 5.0 5.0 -45.1 -52.6 200 200 230 170 224
7/5/2019 16:11:00 5.0 5.0 -45.1 -52.7 200 200 230 170 224
7/5/2019 16:12:00 5.0 5.0 -45.0 -52.6 200 200 230 170 224
7/5/2019 16:13:00 5.0 5.0 -44.9 -52.6 200 200 230 170 222

-------------------------------------------
Approved by Date Page: 59 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 16:14:00 5.0 5.0 -45.0 -52.6 200 200 230 170 222
7/5/2019 16:15:00 5.0 5.0 -45.0 -52.6 200 200 230 170 221
7/5/2019 16:16:00 5.0 5.0 -45.1 -52.6 200 200 230 170 221
7/5/2019 16:17:00 5.0 5.0 -45.1 -52.6 199 200 230 170 221
7/5/2019 16:18:00 5.0 5.0 -45.0 -52.6 199 200 230 170 221
7/5/2019 16:19:00 5.0 5.0 -44.9 -52.5 199 200 230 170 221
7/5/2019 16:20:00 5.0 5.0 -44.9 -52.5 199 200 230 170 221
7/5/2019 16:21:00 5.0 5.0 -44.8 -52.6 199 200 230 170 221
7/5/2019 16:22:00 5.0 5.0 -44.7 -52.5 199 200 230 170 221
7/5/2019 16:23:00 5.0 5.0 -44.6 -52.5 199 200 230 170 221
7/5/2019 16:24:00 5.0 5.0 -44.6 -52.4 199 200 230 170 221
7/5/2019 16:25:00 5.0 5.0 -44.9 -52.4 199 200 230 170 222
7/5/2019 16:26:00 5.0 5.0 -44.9 -52.3 199 200 230 170 221
7/5/2019 16:27:00 5.0 5.0 -44.8 -52.4 199 200 230 170 221
7/5/2019 16:28:00 5.0 5.0 -45.2 -52.7 199 200 230 170 220
7/5/2019 16:29:00 5.0 5.0 -45.8 -53.1 199 200 230 170 217
7/5/2019 16:30:00 5.0 5.0 -46.4 -54.1 199 200 230 170 216
7/5/2019 16:31:00 5.0 5.0 -47.2 -55.1 200 200 230 170 217
7/5/2019 16:32:00 5.0 5.0 -47.8 -55.7 202 200 230 170 217
7/5/2019 16:33:00 4.9 5.0 -48.2 -56.1 200 200 230 170 214
7/5/2019 16:34:00 5.0 5.0 -48.7 -56.5 199 200 230 170 214
7/5/2019 16:35:00 4.9 5.0 -49.0 -56.7 200 200 230 170 214
7/5/2019 16:36:00 5.0 5.0 -49.2 -56.8 202 200 230 170 219
7/5/2019 16:37:00 5.0 5.0 -49.3 -56.7 200 200 230 170 216
7/5/2019 16:38:00 5.0 5.0 -49.4 -56.7 199 200 230 170 215
7/5/2019 16:39:00 5.0 5.0 -49.5 -56.6 200 200 230 170 215
7/5/2019 16:40:00 5.1 5.0 -49.6 -56.6 200 200 230 170 216

-------------------------------------------
Approved by Date Page: 60 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 16:41:00 5.1 5.0 -49.6 -56.6 202 200 230 170 217
7/5/2019 16:42:00 5.1 5.0 -49.6 -56.6 200 200 230 170 218
7/5/2019 16:43:00 5.0 5.0 -49.5 -56.7 199 200 230 170 215
7/5/2019 16:44:00 5.0 5.0 -49.4 -56.7 199 200 230 170 216
7/5/2019 16:45:00 4.9 5.0 -49.3 -56.5 200 200 230 170 217
7/5/2019 16:46:00 4.9 5.0 -49.3 -56.4 200 200 230 170 219
7/5/2019 16:47:00 5.0 5.0 -49.4 -56.4 199 200 230 170 215
7/5/2019 16:48:00 5.0 5.0 -49.5 -56.5 199 200 230 170 216
7/5/2019 16:49:00 5.0 5.0 -49.4 -56.5 200 200 230 170 218
7/5/2019 16:50:00 5.0 5.0 -49.3 -56.5 200 200 230 170 220
7/5/2019 16:51:00 5.0 5.0 -49.3 -56.4 200 200 230 170 214
7/5/2019 16:52:00 5.0 5.0 -49.4 -56.4 199 200 230 170 216
7/5/2019 16:53:00 5.0 5.0 -49.4 -56.4 200 200 230 170 219
7/5/2019 16:54:00 5.0 5.0 -49.3 -56.4 200 200 230 170 217
7/5/2019 16:55:00 5.0 5.0 -49.4 -56.5 199 200 230 170 215
7/5/2019 16:56:00 4.9 5.0 -49.3 -56.6 200 200 230 170 217
7/5/2019 16:57:00 5.0 5.0 -49.2 -56.3 202 200 230 170 220
7/5/2019 16:58:00 5.0 5.0 -49.0 -56.3 199 200 230 170 215
7/5/2019 16:59:00 5.0 5.0 -49.3 -56.4 200 200 230 170 216
7/5/2019 17:00:00 5.0 5.0 -49.5 -56.4 202 200 230 170 219
7/5/2019 17:01:00 5.0 5.0 -49.7 -56.6 200 200 230 170 216
7/5/2019 17:02:00 5.1 5.0 -49.7 -56.6 199 200 230 170 216
7/5/2019 17:03:00 5.1 5.0 -49.7 -56.7 200 200 230 170 219
7/5/2019 17:04:00 5.0 5.0 -49.7 -56.6 202 200 230 170 220
7/5/2019 17:05:00 5.0 5.0 -49.6 -56.5 199 200 230 170 216
7/5/2019 17:06:00 5.0 5.0 -49.6 -56.5 200 200 230 170 218
7/5/2019 17:07:00 5.0 5.0 -49.6 -56.6 202 200 230 170 220

-------------------------------------------
Approved by Date Page: 61 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 17:08:00 5.0 5.0 -49.4 -56.5 200 200 230 170 217
7/5/2019 17:09:00 4.9 5.0 -49.5 -56.5 199 200 230 170 215
7/5/2019 17:10:00 5.0 5.0 -49.5 -56.6 200 200 230 170 219
7/5/2019 17:11:00 5.0 5.0 -49.6 -56.6 201 200 230 170 219
7/5/2019 17:12:00 5.0 5.0 -49.6 -56.6 199 200 230 170 217
7/5/2019 17:13:00 5.0 5.0 -49.6 -56.6 200 200 230 170 219
7/5/2019 17:14:00 5.0 5.0 -49.7 -56.8 202 200 230 170 220
7/5/2019 17:15:00 5.0 5.0 -49.7 -56.8 200 200 230 170 219
7/5/2019 17:16:00 5.0 5.0 -49.7 -56.8 199 200 230 170 217
7/5/2019 17:17:00 5.0 5.0 -49.7 -56.8 200 200 230 170 220
7/5/2019 17:18:00 5.0 5.0 -49.7 -56.8 200 200 230 170 218
7/5/2019 17:19:00 5.0 5.0 -49.8 -56.8 199 200 230 170 217
7/5/2019 17:20:00 5.0 5.0 -49.8 -56.9 202 200 230 170 220
7/5/2019 17:21:00 5.0 5.0 -49.8 -56.9 200 200 230 170 219
7/5/2019 17:22:00 5.0 5.0 -49.8 -56.8 200 200 230 170 217
7/5/2019 17:23:00 5.0 5.0 -49.8 -56.8 202 200 230 170 220
7/5/2019 17:24:00 5.0 5.0 -49.9 -56.9 199 200 230 170 217
7/5/2019 17:25:00 5.0 5.0 -50.0 -56.9 200 200 230 170 219
7/5/2019 17:26:00 5.0 5.0 -50.0 -56.9 201 200 230 170 220
7/5/2019 17:27:00 5.0 5.0 -50.0 -56.9 199 200 230 170 217
7/5/2019 17:28:00 5.0 5.0 -50.0 -56.9 199 200 230 170 217
7/5/2019 17:29:00 5.0 5.0 -50.0 -56.8 202 200 230 170 220
7/5/2019 17:30:00 5.0 5.0 -50.0 -56.7 199 200 230 170 217
7/5/2019 17:31:00 5.0 5.0 -50.0 -56.8 200 200 230 170 220
7/5/2019 17:32:00 5.0 5.0 -50.0 -56.7 201 200 230 170 221
7/5/2019 17:33:00 5.0 5.0 -50.0 -56.8 199 200 230 170 219
7/5/2019 17:34:00 5.1 5.0 -50.0 -56.7 202 200 230 170 221

-------------------------------------------
Approved by Date Page: 62 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 17:35:00 5.1 5.0 -50.0 -56.7 199 200 230 170 219
7/5/2019 17:36:00 5.0 5.0 -50.0 -56.7 199 200 230 170 218
7/5/2019 17:37:00 5.0 5.0 -50.0 -56.6 202 200 230 170 221
7/5/2019 17:38:00 5.0 5.0 -50.0 -56.6 199 200 230 170 219
7/5/2019 17:39:00 5.0 5.0 -50.0 -56.6 200 200 230 170 220
7/5/2019 17:40:00 5.0 5.0 -50.0 -56.7 202 200 230 170 221
7/5/2019 17:41:00 5.0 5.0 -50.1 -56.8 199 200 230 170 219
7/5/2019 17:42:00 5.0 5.0 -50.0 -56.7 200 200 230 170 219
7/5/2019 17:43:00 5.0 5.0 -50.0 -56.6 202 200 230 170 222
7/5/2019 17:44:00 5.0 5.0 -50.0 -56.6 199 200 230 170 220
7/5/2019 17:45:00 5.0 5.0 -50.0 -56.6 200 200 230 170 221
7/5/2019 17:46:00 5.0 5.0 -50.0 -56.6 201 200 230 170 222
7/5/2019 17:47:00 5.0 5.0 -50.0 -56.6 199 200 230 170 220
7/5/2019 17:48:00 5.0 5.0 -50.0 -56.7 200 200 230 170 221
7/5/2019 17:49:00 5.0 5.0 -49.9 -56.6 200 200 230 170 221
7/5/2019 17:50:00 5.0 5.0 -49.9 -56.6 199 200 230 170 220
7/5/2019 17:51:00 5.0 5.0 -49.9 -56.6 202 200 230 170 222
7/5/2019 17:52:00 5.0 5.0 -50.0 -56.6 199 200 230 170 220
7/5/2019 17:53:00 5.0 5.0 -50.0 -56.6 200 200 230 170 221
7/5/2019 17:54:00 5.0 5.0 -50.0 -56.6 202 200 230 170 222
7/5/2019 17:55:00 5.0 5.0 -49.9 -56.6 199 200 230 170 220
7/5/2019 17:56:00 5.0 5.0 -49.9 -56.6 200 200 230 170 222
7/5/2019 17:57:00 5.0 5.0 -49.9 -56.6 200 200 230 170 222
7/5/2019 17:58:00 5.0 5.0 -49.9 -56.6 199 200 230 170 220
7/5/2019 17:59:00 5.0 5.0 -49.9 -56.7 202 200 230 170 224
7/5/2019 18:00:00 5.0 5.0 -49.9 -56.6 199 200 230 170 221
7/5/2019 18:01:00 5.0 5.0 -49.9 -56.7 199 200 230 170 220

-------------------------------------------
Approved by Date Page: 63 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 18:02:00 5.0 5.0 -49.9 -56.7 202 200 230 170 224
7/5/2019 18:03:00 5.0 5.0 -49.9 -56.6 200 200 230 170 221
7/5/2019 18:04:00 5.0 5.0 -50.0 -56.6 200 200 230 170 221
7/5/2019 18:05:00 5.0 5.0 -50.1 -56.6 202 200 230 170 224
7/5/2019 18:06:00 5.0 5.0 -50.1 -56.7 199 200 230 170 221
7/5/2019 18:07:00 5.0 5.0 -50.2 -56.7 200 200 230 170 222
7/5/2019 18:08:00 5.0 5.0 -50.2 -56.6 202 200 230 170 225
7/5/2019 18:09:00 5.0 5.0 -50.2 -56.5 199 200 230 170 221
7/5/2019 18:10:00 5.0 5.0 -50.3 -56.5 200 200 230 170 224
7/5/2019 18:11:00 5.0 5.0 -50.4 -56.5 200 200 230 170 222
7/5/2019 18:12:00 5.0 5.0 -50.5 -56.5 199 200 230 170 221
7/5/2019 18:13:00 5.0 5.0 -50.6 -56.6 202 200 230 170 225
7/5/2019 18:14:00 5.0 5.0 -50.6 -56.6 199 200 230 170 222
7/5/2019 18:15:00 5.0 5.0 -50.7 -56.6 199 200 230 170 221
7/5/2019 18:16:00 5.0 5.0 -50.7 -56.5 202 200 230 170 225
7/5/2019 18:17:00 5.0 5.0 -50.7 -56.5 199 200 230 170 221
7/5/2019 18:18:00 5.0 5.0 -50.7 -56.5 200 200 230 170 224
7/5/2019 18:19:00 5.0 5.0 -50.8 -56.6 200 200 230 170 225
7/5/2019 18:20:00 5.0 5.0 -50.8 -56.6 199 200 230 170 221
7/5/2019 18:21:00 5.0 5.0 -50.9 -56.6 200 200 230 170 224
7/5/2019 18:22:00 5.0 5.0 -51.3 -56.6 200 200 230 170 225
7/5/2019 18:23:00 5.0 5.0 -52.9 -56.6 199 200 230 170 222
7/5/2019 18:24:00 5.0 5.0 -53.6 -56.7 200 200 230 170 224
7/5/2019 18:25:00 5.0 5.0 -53.7 -56.6 200 200 230 170 225
7/5/2019 18:26:00 5.0 5.0 -53.8 -56.6 199 200 230 170 222
7/5/2019 18:27:00 5.0 5.0 -53.7 -56.5 200 200 230 170 225
7/5/2019 18:28:00 5.0 5.0 -53.8 -56.6 200 200 230 170 225

-------------------------------------------
Approved by Date Page: 64 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 18:29:00 5.0 5.0 -53.8 -56.6 199 200 230 170 222
7/5/2019 18:30:00 5.0 5.0 -53.9 -56.7 200 200 230 170 225
7/5/2019 18:31:00 5.0 5.0 -53.8 -56.6 200 200 230 170 225
7/5/2019 18:32:00 5.0 5.0 -53.9 -56.6 199 200 230 170 222
7/5/2019 18:33:00 5.0 5.0 -53.7 -56.6 200 200 230 170 225
7/5/2019 18:34:00 5.0 5.0 -53.4 -56.7 200 200 230 170 225
7/5/2019 18:35:00 5.0 5.0 -53.2 -56.6 199 200 230 170 222
7/5/2019 18:36:00 5.0 5.0 -53.4 -56.6 200 200 230 170 225
7/5/2019 18:37:00 5.0 5.0 -53.6 -56.6 200 200 230 170 225
7/5/2019 18:38:00 5.0 5.0 -53.7 -56.7 199 200 230 170 222
7/5/2019 18:39:00 5.0 5.0 -53.7 -56.6 200 200 230 170 224
7/5/2019 18:40:00 5.0 5.0 -53.7 -56.6 200 200 230 170 226
7/5/2019 18:41:00 5.0 5.0 -53.6 -56.6 199 200 230 170 222
7/5/2019 18:42:00 5.0 5.0 -53.7 -56.7 200 200 230 170 224
7/5/2019 18:43:00 5.0 5.0 -53.6 -56.6 202 200 230 170 226
7/5/2019 18:44:00 5.0 5.0 -53.7 -56.6 199 200 230 170 222
7/5/2019 18:45:00 5.0 5.0 -53.7 -56.6 200 200 230 170 225
7/5/2019 18:46:00 5.0 5.0 -53.6 -56.7 200 200 230 170 226
7/5/2019 18:47:00 5.1 5.0 -53.5 -56.7 199 200 230 170 222
7/5/2019 18:48:00 5.0 5.0 -53.5 -56.6 200 200 230 170 226
7/5/2019 18:49:00 5.0 5.0 -53.6 -56.7 200 200 230 170 225
7/5/2019 18:50:00 5.0 5.0 -53.5 -56.7 199 200 230 170 222
7/5/2019 18:51:00 5.0 5.0 -53.4 -56.6 200 200 230 170 225
7/5/2019 18:52:00 5.0 5.0 -53.5 -56.5 202 200 230 170 226
7/5/2019 18:53:00 5.0 5.0 -53.5 -56.5 199 200 230 170 222
7/5/2019 18:54:00 5.0 5.0 -53.5 -56.5 200 200 230 170 225
7/5/2019 18:55:00 5.0 5.0 -53.4 -56.6 202 200 230 170 226

-------------------------------------------
Approved by Date Page: 65 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 18:56:00 5.0 5.0 -53.3 -56.6 199 200 230 170 224
7/5/2019 18:57:00 5.0 5.0 -53.3 -56.5 200 200 230 170 225
7/5/2019 18:58:00 5.0 5.0 -53.3 -56.5 201 200 230 170 226
7/5/2019 18:59:00 5.0 5.0 -52.8 -56.5 199 200 230 170 224
7/5/2019 19:00:00 5.0 5.0 -51.7 -56.5 200 200 230 170 225
7/5/2019 19:01:00 5.0 5.0 -51.0 -56.4 202 200 230 170 228
7/5/2019 19:02:00 5.0 5.0 -50.6 -56.4 199 200 230 170 224
7/5/2019 19:03:00 5.0 5.0 -50.4 -56.4 200 200 230 170 226
7/5/2019 19:04:00 5.0 5.0 -50.3 -56.4 202 200 230 170 227
7/5/2019 19:05:00 5.0 5.0 -50.2 -56.4 199 200 230 170 224
7/5/2019 19:06:00 5.0 5.0 -50.2 -56.3 200 200 230 170 226
7/5/2019 19:07:00 5.0 5.0 -50.2 -56.3 200 200 230 170 226
7/5/2019 19:08:00 5.0 5.0 -50.3 -56.4 199 200 230 170 224
7/5/2019 19:09:00 5.0 5.0 -50.3 -56.4 200 200 230 170 226
7/5/2019 19:10:00 5.0 5.0 -50.3 -56.3 202 200 230 170 228
7/5/2019 19:11:00 5.0 5.0 -50.3 -56.3 199 200 230 170 224
7/5/2019 19:12:00 5.0 5.0 -50.3 -56.3 200 200 230 170 226
7/5/2019 19:13:00 5.0 5.0 -50.3 -56.3 200 200 230 170 228
7/5/2019 19:14:00 5.0 5.0 -50.2 -56.2 199 200 230 170 225
7/5/2019 19:15:00 5.0 5.0 -50.2 -56.1 200 200 230 170 225
7/5/2019 19:16:00 5.0 5.0 -50.2 -56.1 202 200 230 170 228
7/5/2019 19:17:00 5.0 5.0 -50.2 -56.1 199 200 230 170 224
7/5/2019 19:18:00 5.0 5.0 -50.3 -56.1 199 200 230 170 224
7/5/2019 19:19:00 5.0 5.0 -50.3 -56.1 200 200 230 170 228
7/5/2019 19:20:00 5.0 5.0 -50.3 -56.1 200 200 230 170 226
7/5/2019 19:21:00 5.0 5.0 -50.3 -56.1 199 200 230 170 225
7/5/2019 19:22:00 5.0 5.0 -50.3 -56.2 200 200 230 170 228

-------------------------------------------
Approved by Date Page: 66 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 19:23:00 5.0 5.0 -50.3 -56.1 202 200 230 170 229
7/5/2019 19:24:00 5.0 5.0 -50.2 -55.9 199 200 230 170 225
7/5/2019 19:25:00 5.0 5.0 -50.2 -55.8 199 200 230 170 224
7/5/2019 19:26:00 5.0 5.0 -50.2 -56.0 202 200 230 170 229
7/5/2019 19:27:00 5.0 5.0 -50.2 -56.0 199 200 230 170 225
7/5/2019 19:28:00 5.0 5.0 -50.3 -56.1 200 200 230 170 226
7/5/2019 19:29:00 5.0 5.0 -50.2 -55.6 202 200 230 170 229
7/5/2019 19:30:00 5.0 5.0 -50.1 -55.5 199 200 230 170 226
7/5/2019 19:31:00 5.0 5.0 -50.2 -55.5 200 200 230 170 228
7/5/2019 19:32:00 5.0 5.0 -50.2 -55.5 202 200 230 170 228
7/5/2019 19:33:00 5.0 5.0 -50.3 -55.8 199 200 230 170 224
7/5/2019 19:34:00 5.0 5.0 -50.3 -55.9 201 200 230 170 228
7/5/2019 19:35:00 5.0 5.0 -50.3 -56.0 200 200 230 170 226
7/5/2019 19:36:00 5.0 5.0 -50.4 -56.1 199 200 230 170 222
7/5/2019 19:37:00 5.0 5.0 -50.4 -56.1 202 200 230 170 228
7/5/2019 19:38:00 5.0 5.0 -50.5 -56.1 202 200 230 170 228
7/5/2019 19:39:00 5.0 5.0 -50.4 -56.0 199 200 230 170 225
7/5/2019 19:40:00 5.0 5.0 -50.4 -55.6 200 200 230 170 225
7/5/2019 19:41:00 5.0 5.0 -50.4 -55.8 202 200 230 170 226
7/5/2019 19:42:00 5.0 5.0 -50.5 -55.8 199 200 230 170 224
7/5/2019 19:43:00 5.0 5.0 -50.4 -55.3 200 200 230 170 226
7/5/2019 19:44:00 5.0 5.0 -50.3 -54.8 199 200 230 170 224
7/5/2019 19:45:00 5.0 5.0 -50.2 -54.6 199 200 230 170 222
7/5/2019 19:46:00 5.0 5.0 -50.2 -54.6 200 200 230 170 224
7/5/2019 19:47:00 5.0 5.0 -50.2 -54.6 200 200 230 170 224
7/5/2019 19:48:00 5.0 5.0 -50.2 -54.6 200 200 230 170 225
7/5/2019 19:49:00 5.0 5.0 -50.2 -54.4 200 200 230 170 222

-------------------------------------------
Approved by Date Page: 67 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 19:50:00 5.0 5.0 -50.2 -54.3 200 200 230 170 224
7/5/2019 19:51:00 5.0 5.0 -50.1 -54.3 200 200 230 170 223
7/5/2019 19:52:00 5.0 5.0 -50.1 -54.2 200 200 230 170 225
7/5/2019 19:52:59 Audit: - Trend.grpDuration.strDuration.CurrentValue set to 10 by IDIN.
7/5/2019 19:53:00 5.0 5.0 -50.1 -54.2 200 200 230 170 224
7/5/2019 19:54:00 5.0 5.0 -50.0 -54.1 199 200 230 170 222
7/5/2019 19:55:00 5.0 5.0 -50.0 -54.2 200 200 230 170 224
7/5/2019 19:56:00 5.0 5.0 -50.1 -54.5 199 200 230 170 222
7/5/2019 19:56:59 Audit: - Trend.grpDuration.strDuration.CurrentValue set to 3 by IDIN.
7/5/2019 19:57:00 5.0 5.0 -50.1 -54.5 202 200 230 170 226
7/5/2019 19:58:00 5.0 5.0 -50.1 -54.4 199 200 230 170 222
7/5/2019 19:59:00 5.0 5.0 -50.1 -54.5 200 200 230 170 225
7/5/2019 20:00:00 5.0 5.0 -50.1 -54.7 199 200 230 170 222
7/5/2019 20:01:00 5.0 5.0 -50.2 -54.8 202 200 230 170 225
7/5/2019 20:02:00 5.0 5.0 -50.2 -55.0 199 200 230 170 222
7/5/2019 20:03:00 5.0 5.0 -50.3 -55.8 200 200 230 170 225
7/5/2019 20:04:00 5.0 5.0 -50.4 -56.2 200 200 230 170 224
7/5/2019 20:05:00 5.0 5.0 -50.4 -56.2 199 200 230 170 222
7/5/2019 20:06:00 5.0 5.0 -50.4 -56.0 200 200 230 170 225
7/5/2019 20:07:00 5.0 5.0 -50.5 -56.0 199 200 230 170 222
7/5/2019 20:08:00 5.0 5.0 -50.6 -56.2 202 200 230 170 226
7/5/2019 20:09:00 5.0 5.0 -50.7 -56.4 199 200 230 170 222
7/5/2019 20:10:00 5.0 5.0 -50.6 -56.3 202 200 230 170 226
7/5/2019 20:11:00 5.0 5.0 -50.6 -56.3 199 200 230 170 224
7/5/2019 20:12:00 5.0 5.0 -50.5 -56.3 202 200 230 170 228
7/5/2019 20:13:00 5.0 5.0 -50.5 -56.1 199 200 230 170 224
7/5/2019 20:14:00 5.0 5.0 -50.4 -55.8 200 200 230 170 226

-------------------------------------------
Approved by Date Page: 68 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 20:15:00 5.0 5.0 -50.4 -56.0 199 200 230 170 225
7/5/2019 20:16:00 5.0 5.0 -50.5 -56.2 200 200 230 170 226
7/5/2019 20:17:00 5.0 5.0 -50.5 -56.2 199 200 230 170 225
7/5/2019 20:18:00 5.0 5.0 -50.4 -56.2 200 200 230 170 225
7/5/2019 20:19:00 5.0 5.0 -50.4 -56.2 199 200 230 170 225
7/5/2019 20:20:00 5.0 5.0 -50.5 -56.3 200 200 230 170 226
7/5/2019 20:21:00 5.0 5.0 -50.4 -56.3 200 200 230 170 225
7/5/2019 20:22:00 5.0 5.0 -50.4 -56.3 200 200 230 170 225
7/5/2019 20:23:00 5.0 5.0 -50.4 -56.3 200 200 230 170 225
7/5/2019 20:24:00 5.0 5.0 -50.4 -56.3 200 200 230 170 225
7/5/2019 20:25:00 5.0 5.0 -50.4 -56.1 200 200 230 170 226
7/5/2019 20:26:00 5.0 5.0 -50.4 -55.9 200 200 230 170 226
7/5/2019 20:27:00 4.9 5.0 -50.4 -56.1 199 200 230 170 225
7/5/2019 20:28:00 4.9 5.0 -50.4 -56.2 200 200 230 170 226
7/5/2019 20:29:00 5.0 5.0 -50.4 -56.3 200 200 230 170 225
7/5/2019 20:30:00 5.0 5.0 -50.5 -56.4 200 200 230 170 226
7/5/2019 20:31:00 5.0 5.0 -50.6 -56.5 200 200 230 170 226
7/5/2019 20:32:00 5.0 5.0 -50.6 -56.6 199 200 230 170 226
7/5/2019 20:33:00 5.1 5.0 -50.6 -56.6 202 200 230 170 230
7/5/2019 20:34:00 5.0 5.0 -50.5 -56.5 199 200 230 170 228
7/5/2019 20:35:00 5.0 5.0 -50.6 -56.5 199 200 230 170 229
7/5/2019 20:36:00 5.0 5.0 -50.7 -56.5 202 200 230 170 233
7/5/2019 20:37:00 5.0 5.0 -50.7 -56.5 200 200 230 170 232
7/5/2019 20:38:00 5.0 5.0 -50.7 -56.6 199 200 230 170 229
7/5/2019 20:39:00 4.9 5.0 -50.8 -56.6 200 200 230 170 232
7/5/2019 20:40:00 5.0 5.0 -51.0 -56.7 202 200 230 170 233
7/5/2019 20:41:00 5.0 5.0 -51.2 -56.7 199 200 230 170 230

-------------------------------------------
Approved by Date Page: 69 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 20:42:00 5.0 5.0 -52.8 -56.9 199 200 230 170 230
7/5/2019 20:43:00 5.1 5.0 -53.9 -57.1 200 200 230 170 233
7/5/2019 20:44:00 5.0 5.0 -54.3 -57.1 202 200 230 170 233
7/5/2019 20:45:00 5.0 5.0 -54.5 -57.1 199 200 230 170 230
7/5/2019 20:46:00 5.0 5.0 -54.5 -57.1 199 200 230 170 230
7/5/2019 20:47:00 5.0 5.0 -54.5 -57.1 200 200 230 170 233
7/5/2019 20:48:00 5.0 5.0 -54.5 -57.2 202 200 230 170 234
7/5/2019 20:49:00 5.0 5.0 -54.5 -57.2 199 200 230 170 232
7/5/2019 20:50:00 4.9 5.0 -54.5 -57.2 199 200 230 170 232
7/5/2019 20:51:00 4.9 5.0 -54.5 -57.1 200 200 230 170 233
7/5/2019 20:52:00 5.0 5.0 -54.5 -57.1 202 200 230 170 234
7/5/2019 20:53:00 5.0 5.0 -54.5 -57.2 199 200 230 170 233
7/5/2019 20:54:00 5.0 5.0 -54.5 -57.2 199 200 230 170 232
7/5/2019 20:55:00 5.0 5.0 -54.5 -57.2 200 200 230 170 232
7/5/2019 20:56:00 5.1 5.0 -54.5 -57.1 202 200 230 170 234
7/5/2019 20:57:00 5.1 5.0 -54.5 -57.1 200 200 230 170 234
7/5/2019 20:58:00 5.0 5.0 -54.5 -57.2 199 200 230 170 232
7/5/2019 20:59:00 5.0 5.0 -55.0 -57.1 199 200 230 170 232
7/5/2019 21:00:00 5.0 5.0 -54.6 -57.1 200 200 230 170 233
7/5/2019 21:01:00 5.0 5.0 -54.3 -57.2 202 200 230 170 236
7/5/2019 21:02:00 5.0 5.0 -54.5 -57.2 200 200 230 170 234
7/5/2019 21:03:00 5.0 5.0 -54.6 -57.2 199 200 230 170 232
7/5/2019 21:04:00 4.9 5.0 -54.7 -57.2 199 200 230 170 232
7/5/2019 21:05:00 4.9 5.0 -54.8 -57.2 200 200 230 170 234
7/5/2019 21:06:00 5.0 5.0 -54.8 -57.2 202 200 230 170 235
7/5/2019 21:07:00 5.0 5.0 -54.7 -57.2 200 200 230 170 235
7/5/2019 21:08:00 5.1 5.0 -54.6 -57.3 199 200 230 170 233

-------------------------------------------
Approved by Date Page: 70 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 21:09:00 5.0 5.0 -54.6 -57.3 199 200 230 170 232
7/5/2019 21:10:00 5.0 5.0 -54.5 -57.3 199 200 230 170 233
7/5/2019 21:11:00 5.0 5.0 -54.5 -57.3 200 200 230 170 234
7/5/2019 21:12:00 5.0 5.0 -54.4 -57.3 202 200 230 170 236
7/5/2019 21:13:00 5.0 5.0 -54.5 -57.4 201 200 230 170 236
7/5/2019 21:14:00 5.0 5.0 -54.6 -57.5 199 200 230 170 233
7/5/2019 21:15:00 5.0 5.0 -54.6 -57.5 199 200 230 170 233
7/5/2019 21:16:00 5.0 5.0 -54.6 -57.5 199 200 230 170 233
7/5/2019 21:17:00 5.0 5.0 -54.5 -57.5 200 200 230 170 236
7/5/2019 21:18:00 5.0 5.0 -54.7 -57.6 202 200 230 170 236
7/5/2019 21:19:00 5.0 5.0 -54.8 -57.6 199 200 230 170 233
7/5/2019 21:20:00 5.0 5.0 -54.8 -57.6 199 200 230 170 233
7/5/2019 21:21:00 5.0 5.0 -54.8 -57.7 200 200 230 170 234
7/5/2019 21:22:00 5.0 5.0 -54.8 -57.8 202 200 230 170 236
7/5/2019 21:23:00 5.0 5.0 -55.1 -57.8 200 200 230 170 235
7/5/2019 21:24:00 4.9 5.0 -56.0 -57.8 199 200 230 170 233
7/5/2019 21:25:00 5.0 5.0 -56.4 -57.8 200 200 230 170 234
7/5/2019 21:26:00 5.0 5.0 -56.5 -57.8 202 200 230 170 237
7/5/2019 21:27:00 5.0 5.0 -56.6 -57.9 200 200 230 170 237
7/5/2019 21:28:00 5.0 5.0 -56.4 -57.9 199 200 230 170 234
7/5/2019 21:29:00 5.0 5.0 -56.3 -58.0 199 200 230 170 234
7/5/2019 21:30:00 5.0 5.0 -55.1 -58.3 200 200 230 170 236
7/5/2019 21:31:00 5.0 5.0 -54.6 -58.0 202 200 230 170 237
7/5/2019 21:32:00 5.0 5.0 -54.6 -57.9 199 200 230 170 234
7/5/2019 21:33:00 5.0 5.0 -54.7 -57.9 199 200 230 170 234
7/5/2019 21:34:00 5.0 5.0 -55.0 -58.0 200 200 230 170 236
7/5/2019 21:35:00 5.0 5.0 -55.1 -58.1 202 200 230 170 237

-------------------------------------------
Approved by Date Page: 71 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 21:36:00 5.1 5.0 -55.8 -58.1 200 200 230 170 236
7/5/2019 21:37:00 5.0 5.0 -56.1 -58.1 199 200 230 170 234
7/5/2019 21:38:00 5.0 5.0 -56.2 -58.1 200 200 230 170 236
7/5/2019 21:39:00 5.0 5.0 -56.2 -58.2 202 200 230 170 237
7/5/2019 21:40:00 5.0 5.0 -56.5 -58.2 200 200 230 170 237
7/5/2019 21:41:00 5.0 5.0 -56.4 -58.3 199 200 230 170 234
7/5/2019 21:42:00 5.0 5.0 -56.2 -58.3 199 200 230 170 236
7/5/2019 21:43:00 5.0 5.0 -54.9 -58.3 202 200 230 170 238
7/5/2019 21:44:00 5.0 5.0 -54.7 -58.2 200 200 230 170 237
7/5/2019 21:45:00 5.0 5.0 -54.8 -58.2 199 200 230 170 236
7/5/2019 21:46:00 5.0 5.0 -54.8 -58.3 200 200 230 170 236
7/5/2019 21:47:00 5.0 5.0 -54.9 -58.3 202 200 230 170 238
7/5/2019 21:48:00 5.0 5.0 -55.0 -58.3 199 200 230 170 236
7/5/2019 21:49:00 5.0 5.0 -55.1 -58.3 199 200 230 170 236
7/5/2019 21:50:00 5.0 5.0 -55.1 -58.4 200 200 230 170 238
7/5/2019 21:51:00 5.0 5.0 -55.1 -58.4 200 200 230 170 238
7/5/2019 21:52:00 5.0 5.0 -55.1 -58.2 199 200 230 170 236
7/5/2019 21:53:00 5.0 5.0 -55.1 -58.3 199 200 230 170 237
7/5/2019 21:54:00 5.0 5.0 -55.2 -58.5 202 200 230 170 238
7/5/2019 21:55:00 5.0 5.0 -55.2 -58.5 200 200 230 170 238
7/5/2019 21:56:00 5.0 5.0 -55.3 -58.5 199 200 230 170 235
7/5/2019 21:57:00 4.9 5.0 -55.3 -58.6 200 200 230 170 237
7/5/2019 21:58:00 5.0 5.0 -55.3 -58.7 202 200 230 170 240
7/5/2019 21:59:00 5.0 5.0 -55.3 -58.6 199 200 230 170 237
7/5/2019 22:00:00 5.0 5.0 -55.3 -58.6 199 200 230 170 236
7/5/2019 22:01:00 5.0 5.0 -55.4 -58.8 200 200 230 170 238
7/5/2019 22:02:00 5.0 5.0 -55.5 -58.9 200 200 230 170 240

-------------------------------------------
Approved by Date Page: 72 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 22:03:00 5.0 5.0 -55.5 -58.7 199 200 230 170 237
7/5/2019 22:04:00 5.0 5.0 -55.4 -58.7 200 200 230 170 237
7/5/2019 22:05:00 5.0 5.0 -55.4 -59.0 202 200 230 170 240
7/5/2019 22:06:00 5.0 5.0 -55.4 -58.7 199 200 230 170 237
7/5/2019 22:07:00 5.0 5.0 -55.4 -58.5 200 200 230 170 238
7/5/2019 22:08:00 5.0 5.0 -55.5 -58.7 202 200 230 170 240
7/5/2019 22:09:00 5.0 5.0 -55.5 -58.9 199 200 230 170 237
7/5/2019 22:10:00 5.0 5.0 -55.6 -58.7 200 200 230 170 238
7/5/2019 22:11:00 5.0 5.0 -55.6 -58.6 202 200 230 170 240
7/5/2019 22:12:00 5.0 5.0 -55.6 -58.6 199 200 230 170 237
7/5/2019 22:13:00 5.0 5.0 -55.6 -58.5 199 200 230 170 237
7/5/2019 22:14:00 5.1 5.0 -55.6 -58.4 202 200 230 170 240
7/5/2019 22:15:00 5.0 5.0 -55.6 -58.4 199 200 230 170 237
7/5/2019 22:16:00 5.0 5.0 -55.6 -58.5 200 200 230 170 238
7/5/2019 22:17:00 5.0 5.0 -55.6 -58.3 201 200 230 170 241
7/5/2019 22:18:00 5.0 5.0 -55.6 -58.2 199 200 230 170 237
7/5/2019 22:19:00 5.0 5.0 -55.6 -58.2 202 200 230 170 240
7/5/2019 22:20:00 5.0 5.0 -55.6 -58.2 199 200 230 170 237
7/5/2019 22:21:00 5.0 5.0 -55.5 -58.0 200 200 230 170 238
7/5/2019 22:22:00 5.0 5.0 -55.5 -58.0 200 200 230 170 240
7/5/2019 22:23:00 5.0 5.0 -55.5 -58.1 199 200 230 170 237
7/5/2019 22:24:00 5.0 5.0 -55.4 -58.0 202 200 230 170 240
7/5/2019 22:25:00 5.0 5.0 -55.4 -57.9 199 200 230 170 237
7/5/2019 22:26:00 5.0 5.0 -55.4 -57.9 200 200 230 170 240
7/5/2019 22:27:00 5.0 5.0 -55.5 -58.1 198 200 230 170 237
7/5/2019 22:28:00 5.0 5.0 -55.4 -58.0 200 200 230 170 238
7/5/2019 22:29:00 5.0 5.0 -55.4 -57.9 199 200 230 170 237

-------------------------------------------
Approved by Date Page: 73 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 22:29:31 Audit: - Trend.grpDuration.strDuration.CurrentValue set to 10 by IDIN.
7/5/2019 22:30:00 5.0 5.0 -55.4 -58.1 202 200 230 170 240
7/5/2019 22:31:00 5.0 5.0 -55.5 -58.1 199 200 230 170 237
7/5/2019 22:32:00 5.0 5.0 -55.4 -58.1 200 200 230 170 238
7/5/2019 22:33:00 5.0 5.0 -55.4 -58.1 199 200 230 170 237
7/5/2019 22:34:00 5.0 5.0 -55.4 -58.2 200 200 230 170 238
7/5/2019 22:35:00 5.1 5.0 -55.4 -58.2 199 200 230 170 237
7/5/2019 22:36:00 5.0 5.0 -55.4 -58.1 202 200 230 170 240
7/5/2019 22:37:00 5.0 5.0 -55.4 -58.1 199 200 230 170 237
7/5/2019 22:38:00 5.0 5.0 -55.4 -58.1 200 200 230 170 240
7/5/2019 22:39:00 5.0 5.0 -55.5 -58.1 199 200 230 170 237
7/5/2019 22:40:00 5.0 5.0 -55.4 -58.1 200 200 230 170 237
7/5/2019 22:41:00 5.0 5.0 -55.5 -58.1 200 200 230 170 237
7/5/2019 22:42:00 5.0 5.0 -55.5 -58.1 199 200 230 170 235
7/5/2019 22:43:00 5.0 5.0 -55.5 -58.2 202 200 230 170 238
7/5/2019 22:44:00 5.0 5.0 -55.4 -58.2 199 200 230 170 236
7/5/2019 22:45:00 5.0 5.0 -55.5 -58.3 200 200 230 170 237
7/5/2019 22:46:00 5.0 5.0 -55.5 -58.3 200 200 230 170 237
7/5/2019 22:47:00 5.0 5.0 -55.4 -58.3 199 200 230 170 236
7/5/2019 22:48:00 5.0 5.0 -55.5 -58.4 200 200 230 170 237
7/5/2019 22:49:00 5.0 5.0 -55.5 -58.4 200 200 230 170 235
7/5/2019 22:50:00 5.0 5.0 -55.5 -58.5 199 200 230 170 234
7/5/2019 22:51:00 5.1 5.0 -55.5 -58.5 202 200 230 170 237
7/5/2019 22:52:00 5.0 5.0 -55.6 -58.7 199 200 230 170 234
7/5/2019 22:53:00 5.0 5.0 -55.5 -58.8 199 200 230 170 234
7/5/2019 22:54:00 5.0 5.0 -55.4 -58.9 202 200 230 170 236
7/5/2019 22:55:00 5.0 5.0 -55.3 -58.9 199 200 230 170 233

-------------------------------------------
Approved by Date Page: 74 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 22:56:00 5.0 5.0 -55.1 -58.9 199 200 230 170 233
7/5/2019 22:57:00 4.9 5.0 -54.9 -59.0 202 200 230 170 234
7/5/2019 22:58:00 5.0 5.0 -54.8 -59.2 200 200 230 170 233
7/5/2019 22:59:00 5.0 5.0 -54.8 -59.3 199 200 230 170 232
7/5/2019 23:00:00 5.0 5.0 -55.0 -59.3 202 200 230 170 233
7/5/2019 23:01:00 5.0 5.0 -55.0 -59.4 200 200 230 170 231
7/5/2019 23:02:00 5.0 5.0 -54.9 -59.4 199 200 230 170 230
7/5/2019 23:03:00 5.0 5.0 -54.8 -59.4 200 200 230 170 230
7/5/2019 23:04:00 5.0 5.0 -54.8 -59.6 202 200 230 170 232
7/5/2019 23:05:00 5.0 5.0 -54.7 -59.7 200 200 230 170 230
7/5/2019 23:06:00 5.1 5.0 -54.7 -59.9 199 200 230 170 228
7/5/2019 23:07:00 5.0 5.0 -54.7 -59.9 199 200 230 170 228
7/5/2019 23:08:00 5.0 5.0 -54.6 -60.0 202 200 230 170 229
7/5/2019 23:09:00 5.0 5.0 -54.6 -60.0 200 200 230 170 228
7/5/2019 23:10:00 5.0 5.0 -54.6 -59.9 199 200 230 170 226
7/5/2019 23:11:00 5.0 5.0 -54.5 -60.1 199 200 230 170 226
7/5/2019 23:12:00 5.0 5.0 -54.5 -60.2 202 200 230 170 226
7/5/2019 23:13:00 5.0 5.0 -54.5 -60.4 200 200 230 170 225
7/5/2019 23:14:00 4.9 5.0 -54.6 -60.4 199 200 230 170 224
7/5/2019 23:15:00 5.0 5.0 -54.5 -60.4 199 200 230 170 224
7/5/2019 23:16:00 4.9 5.0 -54.6 -60.4 202 200 230 170 224
7/5/2019 23:17:00 5.0 5.0 -54.6 -60.5 200 200 230 170 222
7/5/2019 23:18:00 5.0 5.0 -54.6 -60.7 199 200 230 170 221
7/5/2019 23:19:00 5.0 5.0 -54.6 -60.7 199 200 230 170 220
7/5/2019 23:20:00 5.0 5.0 -54.6 -60.9 200 200 230 170 221
7/5/2019 23:21:00 5.0 5.0 -54.7 -61.0 200 200 230 170 220
7/5/2019 23:22:00 5.0 5.0 -54.6 -61.0 200 200 230 170 218

-------------------------------------------
Approved by Date Page: 75 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 23:23:00 5.0 5.0 -54.6 -61.0 199 200 230 170 217
7/5/2019 23:24:00 5.1 5.0 -54.7 -61.1 199 200 230 170 217
7/5/2019 23:25:00 5.0 5.0 -54.7 -61.3 202 200 230 170 217
7/5/2019 23:26:00 5.1 5.0 -54.7 -61.5 200 200 230 170 216
7/5/2019 23:27:00 5.0 5.0 -54.8 -61.6 199 200 230 170 215
7/5/2019 23:28:00 5.0 5.0 -54.8 -61.7 199 200 230 170 213
7/5/2019 23:29:00 5.0 5.0 -54.8 -61.8 202 200 230 170 215
7/5/2019 23:30:00 5.0 5.0 -54.7 -61.8 200 200 230 170 213
7/5/2019 23:31:00 5.0 5.0 -54.7 -61.9 199 200 230 170 212
7/5/2019 23:32:00 4.9 5.0 -54.6 -62.0 199 200 230 170 211
7/5/2019 23:33:00 5.0 5.0 -54.7 -62.2 200 200 230 170 211
7/5/2019 23:34:00 5.0 5.0 -54.8 -62.4 202 200 230 170 211
7/5/2019 23:35:00 5.0 5.0 -54.8 -62.5 200 200 230 170 210
7/5/2019 23:36:00 5.0 5.0 -54.9 -62.6 199 200 230 170 207
7/5/2019 23:37:00 5.0 5.0 -54.8 -62.6 199 200 230 170 206
7/5/2019 23:38:00 5.0 5.0 -54.7 -62.7 200 200 230 170 207
7/5/2019 23:39:00 5.0 5.0 -54.6 -63.0 202 200 230 170 207
7/5/2019 23:40:00 5.0 5.0 -54.5 -63.1 200 200 230 170 204
7/5/2019 23:41:00 5.0 5.0 -54.5 -63.2 199 200 230 170 202
7/5/2019 23:42:00 5.0 5.0 -54.4 -63.3 200 200 230 170 203
7/5/2019 23:43:00 5.1 5.0 -54.4 -63.4 202 200 230 170 204
7/5/2019 23:44:00 5.1 5.0 -54.5 -63.4 200 200 230 170 200
7/5/2019 23:45:00 5.0 5.0 -54.6 -63.6 199 200 230 170 199
7/5/2019 23:46:00 5.0 5.0 -54.6 -63.8 200 200 230 170 200
7/5/2019 23:47:00 5.0 5.0 -54.6 -63.9 202 200 230 170 200
7/5/2019 23:48:00 5.0 5.0 -54.7 -64.1 199 200 230 170 198
7/5/2019 23:49:00 5.0 5.0 -54.8 -64.2 199 200 230 170 199

-------------------------------------------
Approved by Date Page: 76 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/5/2019 23:50:00 5.0 5.0 -54.9 -64.2 202 200 230 170 200
7/5/2019 23:51:00 5.0 5.0 -55.0 -64.2 200 200 230 170 199
7/5/2019 23:52:00 4.9 5.0 -55.0 -64.3 199 200 230 170 198
7/5/2019 23:53:00 5.0 5.0 -55.1 -64.4 200 200 230 170 199
7/5/2019 23:54:00 5.0 5.0 -55.3 -64.6 200 200 230 170 197
7/5/2019 23:55:00 5.0 5.0 -55.3 -64.8 199 200 230 170 197
7/5/2019 23:56:00 5.0 5.0 -55.4 -64.8 202 200 230 170 197
7/5/2019 23:57:00 5.0 5.0 -55.5 -64.9 199 200 230 170 196
7/5/2019 23:58:00 5.0 5.0 -55.6 -65.0 201 200 230 170 197
7/5/2019 23:59:00 5.0 5.0 -55.6 -65.1 199 200 230 170 195
7/6/2019 00:00:00 5.0 5.0 -55.7 -65.3 199 200 230 170 196
7/6/2019 00:01:00 5.0 5.0 -55.8 -65.4 200 200 230 170 196
7/6/2019 00:01:02 Audit: - Security Synchronizer: Beginning security synchronization process by SecuritySyochronizer.
Audit: - Security Synchronizer: Function is not enabled on this node, check license/key by SecuritySyochronizer.
7/6/2019 00:02:00 5.0 5.0 -55.8 -65.6 199 200 230 170 195
7/6/2019 00:03:00 5.1 5.0 -55.8 -65.6 200 200 230 170 196
7/6/2019 00:04:00 5.1 5.0 -55.9 -65.7 200 200 230 170 196
7/6/2019 00:05:00 5.0 5.0 -55.9 -65.8 199 200 230 170 195
7/6/2019 00:06:00 5.0 5.0 -55.9 -65.9 202 200 230 170 196
7/6/2019 00:07:00 5.0 5.0 -55.9 -66.0 199 200 230 170 193
7/6/2019 00:08:00 5.0 5.0 -55.9 -66.1 200 200 230 170 193
7/6/2019 00:09:00 5.0 5.0 -56.0 -66.3 202 200 230 170 195
7/6/2019 00:10:00 4.9 5.0 -56.0 -66.3 199 200 230 170 192
7/6/2019 00:11:00 5.0 5.0 -56.1 -66.4 199 200 230 170 192
7/6/2019 00:12:00 5.0 5.0 -56.1 -66.5 199 200 230 170 192
7/6/2019 00:13:00 5.0 5.0 -56.1 -66.6 202 200 230 170 195
7/6/2019 00:14:00 5.0 5.0 -56.2 -66.7 200 200 230 170 193

-------------------------------------------
Approved by Date Page: 77 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/6/2019 00:15:00 5.0 5.0 -56.2 -66.8 199 200 230 170 191
7/6/2019 00:16:00 5.0 5.0 -56.3 -66.9 199 200 230 170 191
7/6/2019 00:17:00 5.0 5.0 -56.4 -67.0 199 200 230 170 191
7/6/2019 00:18:00 5.0 5.0 -56.4 -67.1 199 200 230 170 191
7/6/2019 00:19:00 5.0 5.0 -56.5 -67.2 199 200 230 170 191
7/6/2019 00:20:00 5.0 5.0 -56.6 -67.3 199 200 230 170 190
7/6/2019 00:21:00 5.0 5.0 -56.6 -67.5 199 200 230 170 190
7/6/2019 00:22:00 5.0 5.0 -56.7 -67.6 200 200 230 170 192
7/6/2019 00:23:00 5.0 5.0 -56.7 -67.7 202 200 230 170 193
7/6/2019 00:24:00 5.0 5.0 -56.8 -67.8 200 200 230 170 191
7/6/2019 00:25:00 5.1 5.0 -56.8 -68.0 199 200 230 170 190
7/6/2019 00:26:00 5.0 5.0 -56.9 -68.1 199 200 230 170 191
7/6/2019 00:27:00 5.0 5.0 -56.8 -68.2 202 200 230 170 192
7/6/2019 00:28:00 4.9 5.0 -56.8 -68.4 199 200 230 170 189
7/6/2019 00:29:00 5.0 5.0 -56.8 -68.5 202 200 230 170 192
7/6/2019 00:30:00 4.9 5.0 -56.9 -68.6 199 200 230 170 188
7/6/2019 00:31:00 5.0 5.0 -56.9 -68.7 194 200 230 170 185
7/6/2019 00:32:00 5.1 5.0 -56.9 -68.7 180 200 230 170 168
7/6/2019 00:33:00 5.1 5.0 -57.0 -68.9 215 200 230 170 210
7/6/2019 00:34:00 5.1 5.0 -57.1 -69.0 196 200 230 170 188
7/6/2019 00:35:00 5.0 5.0 -57.1 -69.1 165 200 230 170 149
7/6/2019 00:36:00 5.0 5.0 -57.2 -69.3 179 200 230 170 165
7/6/2019 00:37:00 5.0 5.0 -57.3 -69.4 202 200 230 170 190
7/6/2019 00:38:00 5.0 5.0 -57.4 -69.5 225 200 230 170 218
7/6/2019 00:39:00 5.0 5.0 -57.6 -69.6 230 200 230 170 224
7/6/2019 00:40:00 5.0 5.0 -57.7 -69.8 198 200 230 170 190
7/6/2019 00:41:00 5.0 5.0 -57.7 -70.0 172 200 230 170 156

-------------------------------------------
Approved by Date Page: 78 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/6/2019 00:42:00 5.0 5.0 -57.8 -70.1 190 200 230 170 177
7/6/2019 00:43:00 5.0 5.0 -58.0 -70.2 209 200 230 170 197
7/6/2019 00:44:00 5.0 5.0 -58.1 -70.3 224 200 230 170 215
7/6/2019 00:45:00 5.0 5.0 -58.2 -70.5 222 200 230 170 214
7/6/2019 00:46:00 5.0 5.0 -58.3 -70.6 196 200 230 170 187
7/6/2019 00:47:00 5.0 5.0 -58.4 -70.8 175 200 230 170 159
7/6/2019 00:48:00 5.0 5.0 -58.5 -71.0 231 200 230 170 224
7/6/2019 00:49:00 5.0 5.0 -58.6 -71.1 195 200 230 170 186
7/6/2019 00:50:00 5.0 5.0 -58.6 -71.2 187 200 230 170 174
7/6/2019 00:51:00 5.0 5.0 -58.7 -71.3 228 200 230 170 220
7/6/2019 00:52:00 5.0 5.0 -58.8 -71.5 165 200 230 170 149
7/6/2019 00:53:00 5.0 5.0 -58.8 -71.6 222 200 230 170 215
7/6/2019 00:54:00 5.0 5.0 -58.9 -71.7 188 200 230 170 176
7/6/2019 00:55:00 5.0 5.0 -59.0 -71.9 204 200 230 170 191
7/6/2019 00:56:00 5.1 5.0 -59.1 -72.0 205 200 230 170 198
7/6/2019 00:57:00 5.0 5.0 -59.2 -72.0 190 200 230 170 177
7/6/2019 00:58:00 5.0 5.0 -59.3 -71.8 219 200 230 170 210
7/6/2019 00:59:00 5.0 5.0 -59.3 -71.6 168 200 230 170 153
7/6/2019 01:00:00 5.0 5.0 -59.4 -71.5 228 200 230 170 221
7/6/2019 01:01:00 5.0 5.0 -59.4 -71.6 168 200 230 170 154
7/6/2019 01:02:00 5.0 5.0 -59.6 -71.6 220 200 230 170 210
7/6/2019 01:03:00 5.0 5.0 -59.7 -71.8 199 200 230 170 190
7/6/2019 01:04:00 5.0 5.0 -59.7 -72.0 209 200 230 170 197
7/6/2019 01:05:00 5.1 5.0 -59.6 -72.2 215 200 230 170 207
7/6/2019 01:06:00 5.1 5.0 -59.7 -72.4 202 200 230 170 189
7/6/2019 01:07:00 5.0 5.0 -59.7 -72.3 221 200 230 170 212
7/6/2019 01:08:00 5.0 5.0 -59.8 -72.2 203 200 230 170 190

-------------------------------------------
Approved by Date Page: 79 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/6/2019 01:09:00 5.0 5.0 -59.8 -72.1 222 200 230 170 215
7/6/2019 01:10:00 5.0 5.0 -59.8 -72.3 199 200 230 170 185
7/6/2019 01:11:00 5.0 5.0 -59.8 -72.4 220 200 230 170 212
7/6/2019 01:12:00 5.0 5.0 -59.8 -72.3 202 200 230 170 189
7/6/2019 01:13:00 5.1 5.0 -60.0 -72.4 218 200 230 170 207
7/6/2019 01:14:00 5.1 5.0 -60.0 -72.5 210 200 230 170 197
7/6/2019 01:15:00 5.0 5.0 -60.2 -72.6 195 200 230 170 185
7/6/2019 01:16:00 5.0 5.0 -60.3 -72.6 219 200 230 170 208
7/6/2019 01:17:00 5.0 5.0 -60.4 -72.5 167 200 230 170 152
7/6/2019 01:18:00 5.0 5.0 -60.5 -72.4 225 200 230 170 215
7/6/2019 01:19:00 5.0 5.0 -60.7 -72.5 172 200 230 170 156
7/6/2019 01:20:00 5.1 5.0 -60.5 -72.6 219 200 230 170 210
7/6/2019 01:21:00 5.0 5.0 -60.8 -72.7 189 200 230 170 176
7/6/2019 01:22:00 5.0 5.0 -60.7 -72.6 205 200 230 170 195
7/6/2019 01:23:00 5.0 5.0 -60.6 -72.6 210 200 230 170 199
7/6/2019 01:24:00 5.0 5.0 -60.7 -72.6 185 200 230 170 171
7/6/2019 01:25:00 5.0 5.0 -60.9 -72.5 220 200 230 170 211
7/6/2019 01:26:00 5.1 5.0 -61.0 -72.7 165 200 230 170 150
7/6/2019 01:27:00 5.0 5.0 -61.1 -72.7 222 200 230 170 212
7/6/2019 01:28:00 5.0 5.0 -61.3 -72.7 182 200 230 170 166
7/6/2019 01:29:00 5.0 5.0 -61.3 -72.6 205 200 230 170 196
7/6/2019 01:30:00 5.1 5.0 -61.3 -72.7 213 200 230 170 204
7/6/2019 01:31:00 5.0 5.0 -61.7 -72.7 175 200 230 170 162
7/6/2019 01:32:00 5.0 5.0 -62.0 -72.7 224 200 230 170 212
7/6/2019 01:33:00 5.0 5.0 -62.1 -72.7 176 200 230 170 160
7/6/2019 01:34:00 5.0 5.0 -62.1 -72.7 210 200 230 170 200
7/6/2019 01:35:00 5.0 5.0 -62.4 -72.7 209 200 230 170 198

-------------------------------------------
Approved by Date Page: 80 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/6/2019 01:36:00 5.0 5.0 -62.7 -72.7 174 200 230 170 161
7/6/2019 01:37:00 5.1 5.0 -62.8 -72.7 223 200 230 170 213
7/6/2019 01:38:00 5.0 5.0 -62.9 -72.7 184 200 230 170 169
7/6/2019 01:39:00 5.1 5.0 -63.0 -72.7 198 200 230 170 187
7/6/2019 01:40:00 5.0 5.0 -63.7 -72.7 219 200 230 170 207
7/6/2019 01:41:00 5.1 5.0 -63.9 -72.7 165 200 230 170 150
7/6/2019 01:42:00 5.1 5.0 -63.7 -72.7 218 200 230 170 208
7/6/2019 01:43:00 5.0 5.0 -63.6 -72.8 198 200 230 170 184
7/6/2019 01:44:00 5.0 5.0 -63.5 -72.7 185 200 230 170 171
7/6/2019 01:45:00 5.0 5.0 -63.5 -72.7 222 200 230 170 211
7/6/2019 01:46:00 5.0 5.0 -63.6 -72.7 179 200 230 170 163
7/6/2019 01:47:00 5.0 5.0 -63.8 -72.7 202 200 230 170 190
7/6/2019 01:48:00 5.0 5.0 -63.9 -72.7 218 200 230 170 207
7/6/2019 01:49:00 5.1 5.0 -64.1 -72.8 167 200 230 170 151
7/6/2019 01:50:00 5.0 5.0 -63.8 -72.7 210 200 230 170 199
7/6/2019 01:51:00 5.0 5.0 -63.8 -72.8 212 200 230 170 202
7/6/2019 01:52:00 5.0 5.0 -63.7 -72.7 165 200 230 170 149
7/6/2019 01:53:00 5.1 5.0 -63.7 -72.7 216 200 230 170 206
7/6/2019 01:54:00 5.0 5.0 -63.8 -72.7 208 200 230 170 197
7/6/2019 01:55:00 5.0 5.0 -63.9 -72.7 169 200 230 170 154
7/6/2019 01:56:00 5.0 5.0 -64.0 -72.7 217 200 230 170 207
7/6/2019 01:57:00 5.1 5.0 -63.8 -72.7 205 200 230 170 193
7/6/2019 01:58:00 5.0 5.0 -63.9 -72.7 172 200 230 170 156
7/6/2019 01:59:00 5.0 5.0 -64.0 -72.7 219 200 230 170 208
7/6/2019 02:00:00 5.0 5.0 -64.1 -72.7 206 200 230 170 196
7/6/2019 02:01:00 5.1 5.0 -63.9 -72.8 170 200 230 170 153
7/6/2019 02:02:00 5.1 5.0 -64.0 -72.7 217 200 230 170 207

-------------------------------------------
Approved by Date Page: 81 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/6/2019 02:03:00 5.1 5.0 -64.0 -72.7 206 200 230 170 196
7/6/2019 02:04:00 5.0 5.0 -64.1 -72.6 165 200 230 170 149
7/6/2019 02:05:00 5.0 5.0 -64.2 -72.7 213 200 230 170 202
7/6/2019 02:06:00 5.0 5.0 -64.2 -72.6 212 200 230 170 200
7/6/2019 02:07:00 5.0 5.0 -64.3 -72.6 167 200 230 170 150
7/6/2019 02:08:00 5.0 5.0 -64.3 -72.6 206 200 230 170 196
7/6/2019 02:09:00 5.0 5.0 -64.4 -72.7 219 200 230 170 208
7/6/2019 02:10:00 5.0 5.0 -64.5 -72.6 179 200 230 170 164
7/6/2019 02:11:00 5.0 5.0 -64.6 -72.6 191 200 230 170 177
7/6/2019 02:12:00 5.0 5.0 -64.6 -72.6 220 200 230 170 211
7/6/2019 02:13:00 5.0 5.0 -64.4 -72.6 195 200 230 170 183
7/6/2019 02:14:00 5.0 5.0 -64.4 -72.6 177 200 230 170 162
7/6/2019 02:15:00 5.0 5.0 -64.5 -72.5 218 200 230 170 207
7/6/2019 02:16:00 5.1 5.0 -64.5 -72.5 210 200 230 170 198
7/6/2019 02:17:00 5.0 5.0 -64.5 -72.6 165 200 230 170 150
7/6/2019 02:18:00 5.1 5.0 -64.4 -72.5 204 200 230 170 192
7/6/2019 02:19:00 5.0 5.0 -64.5 -72.6 219 200 230 170 208
7/6/2019 02:20:00 5.1 5.0 -64.5 -72.6 186 200 230 170 173
7/6/2019 02:21:00 5.1 5.0 -64.6 -72.5 182 200 230 170 169
7/6/2019 02:22:00 5.0 5.0 -64.6 -72.5 219 200 230 170 209
7/6/2019 02:23:00 5.1 5.0 -64.5 -72.4 207 200 230 170 196
7/6/2019 02:24:00 5.0 5.0 -64.5 -72.3 165 200 230 170 150
7/6/2019 02:25:00 5.0 5.0 -64.7 -72.3 202 200 230 170 190
7/6/2019 02:26:00 5.1 5.0 -64.8 -72.3 219 200 230 170 208
7/6/2019 02:27:00 5.0 5.0 -64.5 -72.3 192 200 230 170 180
7/6/2019 02:28:00 5.0 5.0 -64.6 -72.3 174 200 230 170 158
7/6/2019 02:29:00 5.0 5.0 -64.7 -72.2 212 200 230 170 200

-------------------------------------------
Approved by Date Page: 82 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/6/2019 02:30:00 5.1 5.0 -64.8 -72.2 215 200 230 170 205
7/6/2019 02:31:00 5.1 5.0 -64.6 -72.2 184 200 230 170 169
7/6/2019 02:32:00 5.0 5.0 -64.6 -72.2 180 200 230 170 166
7/6/2019 02:33:00 5.1 5.0 -64.8 -72.2 217 200 230 170 206
7/6/2019 02:34:00 5.0 5.0 -64.8 -72.2 212 200 230 170 201
7/6/2019 02:35:00 5.0 5.0 -64.8 -72.1 179 200 230 170 163
7/6/2019 02:36:00 5.1 5.0 -64.7 -72.1 185 200 230 170 172
7/6/2019 02:37:00 5.0 5.0 -64.6 -72.0 219 200 230 170 207
7/6/2019 02:38:00 5.1 5.0 -64.7 -72.0 212 200 230 170 200
7/6/2019 02:39:00 5.1 5.0 -64.8 -72.0 179 200 230 170 163
7/6/2019 02:40:00 5.1 5.0 -64.7 -72.0 185 200 230 170 172
7/6/2019 02:41:00 5.0 5.0 -64.7 -71.9 219 200 230 170 207
7/6/2019 02:42:00 5.0 5.0 -64.8 -71.7 212 200 230 170 200
7/6/2019 02:43:00 5.0 5.0 -64.9 -71.6 180 200 230 170 164
7/6/2019 02:44:00 5.0 5.0 -65.0 -71.5 179 200 230 170 164
7/6/2019 02:45:00 5.0 5.0 -64.8 -71.5 215 200 230 170 204
7/6/2019 02:46:00 5.0 5.0 -64.8 -71.5 215 200 230 170 204
7/6/2019 02:47:00 5.0 5.0 -64.9 -71.6 189 200 230 170 176
7/6/2019 02:48:00 5.0 5.0 -65.0 -71.5 173 200 230 170 158
7/6/2019 02:49:00 5.0 5.0 -64.8 -71.6 208 200 230 170 197
7/6/2019 02:50:00 5.0 5.0 -64.9 -71.6 219 200 230 170 207
7/6/2019 02:51:00 5.0 5.0 -65.0 -71.7 202 200 230 170 190
7/6/2019 02:52:00 5.0 5.0 -65.0 -71.7 169 200 230 170 152
7/6/2019 02:53:00 5.1 5.0 -64.9 -71.7 194 200 230 170 182
7/6/2019 02:54:00 5.0 5.0 -65.0 -71.7 219 200 230 170 207
7/6/2019 02:55:00 5.1 5.0 -65.0 -71.6 211 200 230 170 199
7/6/2019 02:56:00 5.1 5.0 -65.1 -71.5 184 200 230 170 168

-------------------------------------------
Approved by Date Page: 83 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/6/2019 02:57:00 5.1 5.0 -65.2 -71.4 177 200 230 170 163
7/6/2019 02:58:00 5.1 5.0 -64.9 -71.3 210 200 230 170 198
7/6/2019 02:59:00 5.0 5.0 -64.9 -71.2 219 200 230 170 207
7/6/2019 03:00:00 5.0 5.0 -65.0 -71.1 201 200 230 170 188
7/6/2019 03:01:00 5.1 5.0 -65.0 -71.2 171 200 230 170 153
7/6/2019 03:02:00 5.0 5.0 -64.9 -71.2 190 200 230 170 177
7/6/2019 03:03:00 5.1 5.0 -65.0 -71.2 217 200 230 170 205
7/6/2019 03:04:00 5.0 5.0 -65.0 -71.2 214 200 230 170 204
7/6/2019 03:05:00 5.1 5.0 -65.1 -71.2 194 200 230 170 182
7/6/2019 03:06:00 5.1 5.0 -65.0 -71.3 169 200 230 170 153
7/6/2019 03:07:00 5.0 5.0 -65.0 -71.2 196 200 230 170 183
7/6/2019 03:08:00 5.0 5.0 -65.1 -71.1 219 200 230 170 206
7/6/2019 03:09:00 5.1 5.0 -65.1 -71.1 212 200 230 170 199
7/6/2019 03:10:00 5.1 5.0 -65.0 -71.1 189 200 230 170 174
7/6/2019 03:11:00 5.1 5.0 -65.2 -71.0 172 200 230 170 157
7/6/2019 03:12:00 5.1 5.0 -65.2 -71.0 203 200 230 170 191
7/6/2019 03:13:00 5.1 5.0 -65.3 -71.0 219 200 230 170 207
7/6/2019 03:14:00 5.1 5.0 -65.1 -70.9 208 200 230 170 197
7/6/2019 03:15:00 5.0 5.0 -65.2 -70.9 185 200 230 170 171
7/6/2019 03:16:00 5.1 5.0 -65.3 -70.9 174 200 230 170 158
7/6/2019 03:17:00 5.1 5.0 -65.3 -70.9 202 200 230 170 190
7/6/2019 03:18:00 5.1 5.0 -65.2 -70.9 219 200 230 170 206
7/6/2019 03:19:00 5.1 5.0 -65.2 -70.9 210 200 230 170 198
7/6/2019 03:20:00 5.1 5.0 -65.3 -70.8 191 200 230 170 177
7/6/2019 03:21:00 5.1 5.0 -65.3 -70.9 172 200 230 170 156
7/6/2019 03:22:00 5.1 5.0 -65.3 -70.8 197 200 230 170 185
7/6/2019 03:23:00 5.1 5.0 -65.2 -70.8 217 200 230 170 205

-------------------------------------------
Approved by Date Page: 84 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/6/2019 03:24:00 5.0 5.0 -65.2 -70.8 212 200 230 170 200
7/6/2019 03:25:00 5.1 5.0 -65.3 -70.9 194 200 230 170 181
7/6/2019 03:26:00 5.1 5.0 -65.2 -70.8 172 200 230 170 155
7/6/2019 03:27:00 5.1 5.0 -65.2 -70.8 193 200 230 170 180
7/6/2019 03:28:00 5.0 5.0 -65.2 -70.8 214 200 230 170 203
7/6/2019 03:29:00 5.0 5.0 -65.3 -70.8 212 200 230 170 201
7/6/2019 03:30:00 5.1 5.0 -65.3 -70.8 197 200 230 170 184
7/6/2019 03:31:00 5.1 5.0 -65.3 -70.8 172 200 230 170 157
7/6/2019 03:32:00 5.1 5.0 -65.3 -70.8 192 200 230 170 178
7/6/2019 03:33:00 5.1 5.0 -65.3 -70.9 214 200 230 170 203
7/6/2019 03:34:00 5.1 5.0 -65.4 -70.8 214 200 230 170 203
7/6/2019 03:35:00 5.0 5.0 -65.5 -70.8 200 200 230 170 189
7/6/2019 03:36:00 5.0 5.0 -65.5 -70.8 178 200 230 170 162
7/6/2019 03:37:00 5.1 5.0 -65.3 -70.8 185 200 230 170 172
7/6/2019 03:38:00 5.1 5.0 -65.3 -70.8 212 200 230 170 200
7/6/2019 03:39:00 5.1 5.0 -65.4 -70.7 215 200 230 170 204
7/6/2019 03:40:00 5.1 5.0 -65.4 -70.8 202 200 230 170 190
7/6/2019 03:41:00 5.1 5.0 -65.3 -70.8 181 200 230 170 166
7/6/2019 03:42:00 5.1 5.0 -65.3 -70.8 182 200 230 170 168
7/6/2019 03:43:00 5.1 5.0 -65.5 -70.8 208 200 230 170 197
7/6/2019 03:44:00 5.1 5.0 -65.5 -70.8 216 200 230 170 205
7/6/2019 03:45:00 5.1 5.0 -65.3 -70.8 205 200 230 170 193
7/6/2019 03:46:00 5.1 5.0 -65.3 -70.8 187 200 230 170 174
7/6/2019 03:47:00 5.1 5.0 -65.4 -70.8 178 200 230 170 162
7/6/2019 03:48:00 5.0 5.0 -65.3 -70.8 201 200 230 170 189
7/6/2019 03:49:00 5.1 5.0 -65.3 -70.8 217 200 230 170 205
7/6/2019 03:50:00 5.0 5.0 -65.5 -70.8 210 200 230 170 199

-------------------------------------------
Approved by Date Page: 85 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/6/2019 03:51:00 5.0 5.0 -65.5 -70.8 194 200 230 170 180
7/6/2019 03:52:00 5.1 5.0 -65.5 -70.8 177 200 230 170 162
7/6/2019 03:53:00 5.1 5.0 -65.6 -70.8 197 200 230 170 184
7/6/2019 03:54:00 5.0 5.0 -65.6 -70.8 215 200 230 170 204
7/6/2019 03:55:00 5.1 5.0 -65.6 -70.8 211 200 230 170 199
7/6/2019 03:56:00 5.0 5.0 -65.4 -70.8 195 200 230 170 183
7/6/2019 03:57:00 5.1 5.0 -65.5 -70.8 179 200 230 170 162
7/6/2019 03:58:00 5.1 5.0 -65.4 -70.8 194 200 230 170 180
7/6/2019 03:59:00 5.1 5.0 -65.4 -70.8 214 200 230 170 203
7/6/2019 04:00:00 5.1 5.0 -65.5 -70.8 212 200 230 170 199
7/6/2019 04:01:00 5.1 5.0 -65.5 -70.9 196 200 230 170 184
7/6/2019 04:02:00 5.0 5.0 -65.6 -70.8 179 200 230 170 163
7/6/2019 04:03:00 5.1 5.0 -65.6 -70.8 195 200 230 170 183
7/6/2019 04:04:00 5.0 5.0 -65.6 -70.8 215 200 230 170 204
7/6/2019 04:05:00 5.1 5.0 -65.5 -70.8 212 200 230 170 200
7/6/2019 04:06:00 5.1 5.0 -65.5 -70.9 195 200 230 170 183
7/6/2019 04:07:00 5.0 5.0 -65.5 -70.9 179 200 230 170 164
7/6/2019 04:08:00 5.1 5.0 -65.5 -70.9 198 200 230 170 185
7/6/2019 04:09:00 5.0 5.0 -65.6 -70.9 215 200 230 170 203
7/6/2019 04:10:00 5.0 5.0 -65.6 -70.9 208 200 230 170 197
7/6/2019 04:11:00 5.1 5.0 -65.7 -70.9 192 200 230 170 179
7/6/2019 04:12:00 5.0 5.0 -65.7 -70.9 180 200 230 170 165
7/6/2019 04:13:00 5.1 5.0 -65.7 -70.9 203 200 230 170 190
7/6/2019 04:14:00 5.1 5.0 -65.8 -70.9 215 200 230 170 204
7/6/2019 04:15:00 5.0 5.0 -65.6 -70.9 205 200 230 170 194
7/6/2019 04:16:00 5.1 5.0 -65.7 -70.9 188 200 230 170 174
7/6/2019 04:17:00 5.1 5.0 -65.6 -70.9 185 200 230 170 169

-------------------------------------------
Approved by Date Page: 86 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/6/2019 04:18:00 5.1 5.0 -65.6 -70.9 206 200 230 170 195
7/6/2019 04:19:00 5.0 5.0 -65.7 -70.9 215 200 230 170 204
7/6/2019 04:20:00 5.1 5.0 -65.8 -70.9 205 200 230 170 192
7/6/2019 04:21:00 5.1 5.0 -65.7 -70.8 185 200 230 170 172
7/6/2019 04:22:00 5.1 5.0 -65.8 -70.9 187 200 230 170 173
7/6/2019 04:23:00 5.1 5.0 -65.8 -70.9 210 200 230 170 198
7/6/2019 04:24:00 5.1 5.0 -65.8 -70.9 213 200 230 170 203
7/6/2019 04:25:00 5.1 5.0 -65.7 -70.9 200 200 230 170 188
7/6/2019 04:26:00 5.0 5.0 -65.7 -70.9 185 200 230 170 169
7/6/2019 04:27:00 5.0 5.0 -65.8 -71.0 190 200 230 170 176
7/6/2019 04:28:00 5.1 5.0 -65.8 -70.9 212 200 230 170 201
7/6/2019 04:29:00 5.0 5.0 -65.8 -70.9 210 200 230 170 199
7/6/2019 04:30:00 5.1 5.0 -65.8 -70.9 195 200 230 170 183
7/6/2019 04:31:00 5.1 5.0 -65.9 -71.0 183 200 230 170 169
7/6/2019 04:32:00 5.1 5.0 -65.9 -71.0 201 200 230 170 189
7/6/2019 04:33:00 5.1 5.0 -65.9 -71.0 215 200 230 170 204
7/6/2019 04:34:00 5.0 5.0 -65.9 -71.0 205 200 230 170 195
7/6/2019 04:35:00 5.1 5.0 -66.0 -71.0 189 200 230 170 176
7/6/2019 04:36:00 5.1 5.0 -65.9 -70.9 187 200 230 170 172
7/6/2019 04:37:00 5.1 5.0 -65.9 -71.0 209 200 230 170 197
7/6/2019 04:38:00 5.0 5.0 -65.9 -71.0 212 200 230 170 201
7/6/2019 04:39:00 5.1 5.0 -66.0 -71.0 199 200 230 170 186
7/6/2019 04:40:00 5.1 5.0 -66.0 -71.0 185 200 230 170 170
7/6/2019 04:41:00 5.1 5.0 -66.0 -71.0 198 200 230 170 185
7/6/2019 04:42:00 5.0 5.0 -66.0 -71.0 214 200 230 170 203
7/6/2019 04:43:00 5.1 5.0 -66.0 -71.0 203 200 230 170 191
7/6/2019 04:44:00 5.1 5.0 -66.1 -71.0 187 200 230 170 174

-------------------------------------------
Approved by Date Page: 87 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/6/2019 04:45:00 5.0 5.0 -66.1 -71.1 195 200 230 170 183
7/6/2019 04:46:00 5.1 5.0 -66.1 -71.1 212 200 230 170 200
7/6/2019 04:47:00 5.0 5.0 -66.1 -71.1 203 200 230 170 191
7/6/2019 04:48:00 5.0 5.0 -66.1 -71.1 192 200 230 170 178
7/6/2019 04:49:00 5.1 5.0 -66.1 -71.1 194 200 230 170 180
7/6/2019 04:50:00 5.1 5.0 -66.1 -71.1 207 200 230 170 195
7/6/2019 04:51:00 5.0 5.0 -66.1 -71.0 205 200 230 170 192
7/6/2019 04:52:00 5.1 5.0 -66.1 -71.1 199 200 230 170 185
7/6/2019 04:53:00 5.0 5.0 -66.1 -71.1 195 200 230 170 182
7/6/2019 04:54:00 5.0 5.0 -66.1 -71.1 200 200 230 170 187
7/6/2019 04:55:00 5.1 5.0 -66.1 -71.0 203 200 230 170 189
7/6/2019 04:56:00 5.0 5.0 -66.2 -71.0 204 200 230 170 189
7/6/2019 04:57:00 5.1 5.0 -66.2 -71.0 202 200 230 170 189
7/6/2019 04:58:00 5.1 5.0 -66.2 -71.1 200 200 230 170 188
7/6/2019 04:59:00 5.0 5.0 -66.3 -71.0 199 200 230 170 187
7/6/2019 05:00:00 5.1 5.0 -66.3 -71.1 200 200 230 170 188
7/6/2019 05:01:00 5.0 5.0 -66.3 -71.1 200 200 230 170 188
7/6/2019 05:02:00 5.1 5.0 -66.3 -71.1 200 200 230 170 188
7/6/2019 05:03:00 5.1 5.0 -66.3 -71.1 200 200 230 170 188
7/6/2019 05:04:00 5.0 5.0 -66.3 -71.1 200 200 230 170 188
7/6/2019 05:05:00 5.1 5.0 -66.3 -71.1 200 200 230 170 188
7/6/2019 05:06:00 5.1 5.0 -66.3 -71.1 200 200 230 170 188
7/6/2019 05:07:00 5.0 5.0 -66.3 -71.1 200 200 230 170 188
7/6/2019 05:08:00 5.1 5.0 -66.3 -71.1 200 200 230 170 187
7/6/2019 05:09:00 5.1 5.0 -66.3 -71.1 200 200 230 170 188
7/6/2019 05:10:00 5.1 5.0 -66.4 -71.1 200 200 230 170 187
7/6/2019 05:11:00 5.1 5.0 -66.4 -71.1 200 200 230 170 188

-------------------------------------------
Approved by Date Page: 88 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/6/2019 05:12:00 5.1 5.0 -66.4 -71.1 200 200 230 170 188
7/6/2019 05:13:00 5.1 5.0 -66.4 -71.1 200 200 230 170 188
7/6/2019 05:14:00 5.1 5.0 -66.4 -71.0 200 200 230 170 188
7/6/2019 05:15:00 5.1 5.0 -66.4 -70.9 200 200 230 170 188
7/6/2019 05:16:00 5.1 5.0 -66.4 -70.8 200 200 230 170 188
7/6/2019 05:17:00 5.1 5.0 -66.4 -70.8 200 200 230 170 188
7/6/2019 05:18:00 5.0 5.0 -66.4 -70.8 200 200 230 170 188
7/6/2019 05:19:00 5.1 5.0 -66.5 -70.8 200 200 230 170 188
7/6/2019 05:20:00 5.1 5.0 -66.5 -70.7 200 200 230 170 188
7/6/2019 05:21:00 5.0 5.0 -66.5 -70.7 200 200 230 170 188
7/6/2019 05:22:00 5.0 5.0 -66.5 -70.6 200 200 230 170 188
7/6/2019 05:23:00 5.1 5.0 -66.5 -70.7 200 200 230 170 188
7/6/2019 05:24:00 5.0 5.0 -66.5 -70.7 200 200 230 170 188
7/6/2019 05:25:00 5.0 5.0 -66.5 -70.7 200 200 230 170 188
7/6/2019 05:26:00 5.0 5.0 -66.5 -70.8 200 200 230 170 188
7/6/2019 05:27:00 5.1 5.0 -66.5 -70.8 200 200 230 170 188
7/6/2019 05:28:00 5.0 5.0 -66.6 -70.8 200 200 230 170 187
7/6/2019 05:29:00 5.0 5.0 -66.6 -70.9 200 200 230 170 187
7/6/2019 05:30:00 5.1 5.0 -66.6 -70.8 200 200 230 170 187
7/6/2019 05:31:00 5.0 5.0 -66.6 -70.8 200 200 230 170 188
7/6/2019 05:32:00 5.1 5.0 -66.6 -70.8 200 200 230 170 188
7/6/2019 05:33:00 5.1 5.0 -66.6 -70.7 200 200 230 170 188
7/6/2019 05:34:00 5.0 5.0 -66.6 -70.7 200 200 230 170 188
7/6/2019 05:35:00 5.1 5.0 -66.6 -70.8 200 200 230 170 188
7/6/2019 05:36:00 5.1 5.0 -66.7 -70.8 200 200 230 170 188
7/6/2019 05:37:00 5.0 5.0 -66.7 -70.8 200 200 230 170 188
7/6/2019 05:38:00 5.1 5.0 -66.6 -70.9 199 200 230 170 188

-------------------------------------------
Approved by Date Page: 89 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/6/2019 05:39:00 5.0 5.0 -66.7 -70.9 200 200 230 170 188
7/6/2019 05:40:00 5.0 5.0 -66.7 -70.9 200 200 230 170 188
7/6/2019 05:41:00 5.1 5.0 -66.7 -70.9 200 200 230 170 188
7/6/2019 05:42:00 5.0 5.0 -66.7 -71.0 200 200 230 170 188
7/6/2019 05:43:00 5.1 5.0 -66.7 -71.0 200 200 230 170 188
7/6/2019 05:44:00 5.1 5.0 -66.8 -71.1 200 200 230 170 188
7/6/2019 05:45:00 5.1 5.0 -66.7 -71.0 200 200 230 170 188
7/6/2019 05:46:00 5.1 5.0 -66.8 -71.0 200 200 230 170 188
7/6/2019 05:47:00 5.0 5.0 -66.7 -71.1 200 200 230 170 188
7/6/2019 05:48:00 5.0 5.0 -66.8 -71.1 200 200 230 170 188
7/6/2019 05:49:00 5.1 5.0 -66.8 -71.1 200 200 230 170 188
7/6/2019 05:50:00 5.0 5.0 -66.8 -71.1 200 200 230 170 188
7/6/2019 05:51:00 5.1 5.0 -66.8 -71.1 200 200 230 170 188
7/6/2019 05:52:00 5.1 5.0 -66.8 -71.1 200 200 230 170 188
7/6/2019 05:53:00 5.0 5.0 -66.8 -71.2 200 200 230 170 188
7/6/2019 05:54:00 5.1 5.0 -66.8 -71.2 200 200 230 170 187
7/6/2019 05:55:00 5.1 5.0 -66.8 -71.2 200 200 230 170 188
7/6/2019 05:56:00 5.0 5.0 -66.8 -71.2 200 200 230 170 187
7/6/2019 05:57:00 5.1 5.0 -66.9 -71.2 200 200 230 170 188
7/6/2019 05:58:00 5.0 5.0 -66.9 -71.2 200 200 230 170 188
7/6/2019 05:59:00 5.1 5.0 -66.9 -71.2 200 200 230 170 188
7/6/2019 06:00:00 5.1 5.0 -66.9 -71.2 200 200 230 170 188
7/6/2019 06:01:00 5.1 5.0 -66.9 -71.2 200 200 230 170 188
7/6/2019 06:02:00 5.1 5.0 -66.9 -71.2 200 200 230 170 188
7/6/2019 06:03:00 5.1 5.0 -66.9 -71.1 200 200 230 170 188
7/6/2019 06:04:00 5.0 5.0 -66.9 -71.1 200 200 230 170 188
7/6/2019 06:05:00 5.1 5.0 -66.9 -71.1 200 200 230 170 188

-------------------------------------------
Approved by Date Page: 90 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/6/2019 06:06:00 5.1 5.0 -66.9 -71.0 200 200 230 170 188
7/6/2019 06:07:00 5.0 5.0 -66.9 -70.9 200 200 230 170 188
7/6/2019 06:08:00 5.1 5.0 -66.9 -70.9 200 200 230 170 188
7/6/2019 06:09:00 5.0 5.0 -66.9 -70.8 200 200 230 170 188
7/6/2019 06:10:00 5.1 5.0 -67.0 -70.8 200 200 230 170 188
7/6/2019 06:11:00 5.1 5.0 -66.9 -70.7 200 200 230 170 188
7/6/2019 06:12:00 5.0 5.0 -66.9 -70.7 200 200 230 170 188
7/6/2019 06:13:00 5.1 5.0 -67.0 -70.8 200 200 230 170 188
7/6/2019 06:14:00 5.1 5.0 -67.0 -70.8 200 200 230 170 188
7/6/2019 06:15:00 5.1 5.0 -67.0 -70.8 200 200 230 170 188
7/6/2019 06:16:00 5.1 5.0 -67.0 -70.9 200 200 230 170 188
7/6/2019 06:17:00 5.1 5.0 -67.0 -71.0 200 200 230 170 188
7/6/2019 06:18:00 5.1 5.0 -67.0 -71.0 200 200 230 170 188
7/6/2019 06:19:00 5.1 5.0 -67.0 -71.0 200 200 230 170 188
7/6/2019 06:20:00 5.0 5.0 -67.0 -71.0 200 200 230 170 188
7/6/2019 06:21:00 5.1 5.0 -67.0 -71.1 200 200 230 170 188
7/6/2019 06:22:00 5.1 5.0 -67.1 -71.1 200 200 230 170 188
7/6/2019 06:23:00 5.0 5.0 -67.1 -71.1 200 200 230 170 187
7/6/2019 06:24:00 5.1 5.0 -67.1 -71.1 200 200 230 170 187
7/6/2019 06:25:00 5.1 5.0 -67.0 -71.0 200 200 230 170 187
7/6/2019 06:26:00 5.1 5.0 -67.1 -70.9 200 200 230 170 187
7/6/2019 06:27:00 5.1 5.0 -67.0 -70.8 200 200 230 170 188
7/6/2019 06:28:00 5.1 5.0 -67.1 -70.9 200 200 230 170 188
7/6/2019 06:29:00 5.0 5.0 -67.0 -70.8 200 200 230 170 187
7/6/2019 06:30:00 5.1 5.0 -67.0 -70.8 200 200 230 170 187
7/6/2019 06:30:30 Event: - Step advanced to [9] Drying
7/6/2019 06:31:00 5.1 5.2 -67.1 -70.9 200 200 230 170 188

-------------------------------------------
Approved by Date Page: 91 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/6/2019 06:32:00 5.2 5.8 -67.1 -71.1 200 200 230 170 188
7/6/2019 06:33:00 5.5 6.2 -67.1 -71.5 200 200 230 170 188
7/6/2019 06:34:00 6.2 6.8 -67.1 -71.8 200 200 230 170 188
7/6/2019 06:35:00 6.9 7.2 -67.1 -72.1 200 200 230 170 188
7/6/2019 06:36:00 7.7 7.8 -67.2 -72.5 200 200 230 170 188
7/6/2019 06:37:00 8.4 8.2 -67.2 -72.7 200 200 230 170 188
7/6/2019 06:38:00 9.0 8.8 -67.2 -73.1 200 200 230 170 188
7/6/2019 06:39:00 9.5 9.2 -67.2 -73.4 200 200 230 170 188
7/6/2019 06:40:00 9.9 9.8 -67.3 -73.7 200 200 230 170 188
7/6/2019 06:41:00 10.2 10.2 -67.3 -73.9 200 200 230 170 188
7/6/2019 06:42:00 10.6 10.8 -67.3 -74.1 200 200 230 170 188
7/6/2019 06:43:00 11.1 11.2 -67.4 -74.4 200 200 230 170 188
7/6/2019 06:44:00 11.6 11.8 -67.4 -74.6 200 200 230 170 187
7/6/2019 06:45:00 12.2 12.2 -67.4 -74.8 200 200 230 170 187
7/6/2019 06:46:00 12.7 12.8 -67.5 -75.1 200 200 230 170 187
7/6/2019 06:47:00 13.3 13.2 -67.5 -75.2 200 200 230 170 187
7/6/2019 06:48:00 13.8 13.8 -67.5 -75.4 200 200 230 170 187
7/6/2019 06:49:00 14.3 14.2 -67.6 -75.6 200 200 230 170 187
7/6/2019 06:50:00 14.8 14.8 -67.6 -75.7 200 200 230 170 187
7/6/2019 06:51:00 15.3 15.2 -67.6 -75.8 200 200 230 170 187
7/6/2019 06:52:00 15.7 15.8 -67.7 -75.9 200 200 230 170 187
7/6/2019 06:53:00 16.2 16.2 -67.7 -76.0 200 200 230 170 187
7/6/2019 06:54:00 16.7 16.8 -67.7 -76.1 200 200 230 170 187
7/6/2019 06:55:00 17.2 17.2 -67.8 -76.1 200 200 230 170 187
7/6/2019 06:56:00 17.7 17.8 -67.8 -76.2 200 200 230 170 187
7/6/2019 06:57:00 18.2 18.2 -67.9 -76.3 200 200 230 170 187
7/6/2019 06:58:00 18.8 18.8 -67.9 -76.4 200 200 230 170 187

-------------------------------------------
Approved by Date Page: 92 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/6/2019 06:59:00 19.3 19.2 -68.0 -76.5 200 200 230 170 187
7/6/2019 07:00:00 19.8 19.8 -68.0 -76.6 200 200 230 170 187
7/6/2019 07:01:00 20.3 20.2 -68.0 -76.6 200 200 230 170 187
7/6/2019 07:02:00 20.7 20.8 -68.1 -76.6 200 200 230 170 187
7/6/2019 07:03:00 21.3 21.2 -68.1 -76.7 200 200 230 170 187
7/6/2019 07:04:00 21.7 21.8 -68.1 -76.8 200 200 230 170 187
7/6/2019 07:05:00 22.2 22.2 -68.2 -76.9 200 200 230 170 187
7/6/2019 07:06:00 22.7 22.8 -68.2 -76.9 200 200 230 170 187
7/6/2019 07:07:00 23.2 23.2 -68.3 -77.0 200 200 230 170 187
7/6/2019 07:08:00 23.7 23.8 -68.3 -77.0 200 200 230 170 187
7/6/2019 07:09:00 24.2 24.2 -68.3 -77.0 200 200 230 170 187
7/6/2019 07:10:00 24.8 24.8 -68.4 -77.1 200 200 230 170 187
7/6/2019 07:11:00 25.3 25.2 -68.4 -77.2 200 200 230 170 187
7/6/2019 07:12:00 25.8 25.8 -68.4 -77.2 200 200 230 170 187
7/6/2019 07:13:00 26.3 26.2 -68.5 -77.2 200 200 230 170 187
7/6/2019 07:14:00 26.7 26.8 -68.5 -77.3 200 200 230 170 187
7/6/2019 07:15:00 27.2 27.2 -68.6 -77.3 200 200 230 170 187
7/6/2019 07:16:00 27.7 27.8 -68.7 -77.4 200 200 230 170 187
7/6/2019 07:17:00 28.2 28.2 -68.7 -77.4 200 200 230 170 187
7/6/2019 07:18:00 28.7 28.8 -68.8 -77.5 200 200 230 170 187
7/6/2019 07:19:00 29.2 29.2 -68.8 -77.5 200 200 230 170 187
7/6/2019 07:20:00 29.8 29.8 -68.8 -77.5 200 200 230 170 187
7/6/2019 07:21:00 30.3 30.2 -68.8 -77.6 200 200 230 170 187
7/6/2019 07:22:00 30.8 30.8 -68.9 -77.6 200 200 230 170 187
7/6/2019 07:23:00 31.3 31.2 -68.9 -77.6 200 200 230 170 187
7/6/2019 07:24:00 31.7 31.8 -69.0 -77.6 200 200 230 170 187
7/6/2019 07:25:00 32.2 32.2 -69.0 -77.7 200 200 230 170 187

-------------------------------------------
Approved by Date Page: 93 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/6/2019 07:26:00 32.7 32.8 -69.1 -77.7 200 200 230 170 187
7/6/2019 07:27:00 33.2 33.2 -69.1 -77.7 200 200 230 170 188
7/6/2019 07:28:00 33.7 33.8 -69.1 -77.7 200 200 230 170 187
7/6/2019 07:29:00 34.2 34.2 -69.1 -77.8 200 200 230 170 187
7/6/2019 07:30:00 34.7 34.8 -69.1 -77.8 200 200 230 170 187
7/6/2019 07:31:00 35.2 35.2 -69.2 -77.8 200 200 230 170 187
7/6/2019 07:32:00 35.7 35.8 -69.2 -77.8 200 200 230 170 187
7/6/2019 07:33:00 36.2 36.2 -69.3 -77.9 200 200 230 170 187
7/6/2019 07:34:00 36.8 36.8 -69.3 -77.9 200 200 230 170 187
7/6/2019 07:35:00 37.3 37.2 -69.3 -77.9 200 200 230 170 187
7/6/2019 07:36:00 37.8 37.8 -69.4 -78.0 199 200 230 170 187
7/6/2019 07:37:00 38.3 38.2 -69.4 -78.0 200 200 230 170 187
7/6/2019 07:38:00 38.7 38.8 -69.4 -78.0 200 200 230 170 187
7/6/2019 07:39:00 39.2 39.2 -69.5 -78.0 200 200 230 170 187
7/6/2019 07:40:00 39.7 39.8 -69.5 -78.0 200 200 230 170 187
7/6/2019 07:41:00 40.2 40.2 -69.5 -78.1 200 200 230 170 187
7/6/2019 07:42:00 40.7 40.8 -69.6 -78.1 200 200 230 170 187
7/6/2019 07:43:00 41.3 41.2 -69.6 -78.1 200 200 230 170 187
7/6/2019 07:44:00 41.8 41.8 -69.6 -78.1 200 200 230 170 187
7/6/2019 07:45:00 42.3 42.2 -69.6 -78.1 200 200 230 170 187
7/6/2019 07:46:00 42.8 42.8 -69.6 -78.2 200 200 230 170 187
7/6/2019 07:47:00 43.2 43.2 -69.7 -78.3 200 200 230 170 187
7/6/2019 07:48:00 43.7 43.8 -69.8 -78.3 200 200 230 170 187
7/6/2019 07:49:00 44.2 44.2 -69.8 -78.3 200 200 230 170 187
7/6/2019 07:50:00 44.7 44.8 -69.8 -78.3 200 200 230 170 187
7/6/2019 07:51:00 45.2 45.2 -69.8 -78.3 200 200 230 170 187
7/6/2019 07:52:00 45.7 45.8 -69.8 -78.3 200 200 230 170 187

-------------------------------------------
Approved by Date Page: 94 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/6/2019 07:53:00 46.2 46.2 -69.9 -78.3 200 200 230 170 187
7/6/2019 07:54:00 46.8 46.8 -69.9 -78.3 200 200 230 170 187
7/6/2019 07:55:00 47.3 47.2 -69.9 -78.4 200 200 230 170 187
7/6/2019 07:56:00 47.8 47.8 -69.9 -78.4 200 200 230 170 187
7/6/2019 07:57:00 48.3 48.2 -70.0 -78.4 200 200 230 170 187
7/6/2019 07:58:00 48.8 48.8 -70.1 -78.4 200 200 230 170 187
7/6/2019 07:59:00 49.3 49.2 -70.1 -78.4 200 200 230 170 187
7/6/2019 08:00:00 49.8 49.8 -70.1 -78.4 200 200 230 170 187
7/6/2019 08:00:30 Event: - Step advanced to [10] Drying
7/6/2019 08:00:38 Audit: - Trend.grpDuration.strDuration.CurrentValue set to 30 by IDIN.
7/6/2019 08:01:00 50.2 50.0 -70.1 -78.4 200 200 230 170 187
7/6/2019 08:02:00 50.6 50.0 -70.1 -78.4 200 200 230 170 187
7/6/2019 08:02:08 Audit: - Trend.grpDuration.strDuration.CurrentValue set to 28 by IDIN.
7/6/2019 08:03:00 50.7 50.0 -70.2 -78.4 199 200 230 170 186
7/6/2019 08:04:00 50.5 50.0 -70.2 -78.5 200 200 230 170 187
7/6/2019 08:05:00 50.3 50.0 -70.3 -78.5 200 200 230 170 186
7/6/2019 08:06:00 50.1 50.0 -70.3 -78.4 200 200 230 170 186
7/6/2019 08:07:00 49.9 50.0 -70.3 -78.3 200 200 230 170 187
7/6/2019 08:08:00 49.7 50.0 -70.3 -78.3 200 200 230 170 186
7/6/2019 08:09:00 49.7 50.0 -70.3 -78.3 200 200 230 170 186
7/6/2019 08:10:00 49.8 50.0 -70.4 -78.3 200 200 230 170 186
7/6/2019 08:11:00 49.9 50.0 -70.4 -78.3 200 200 230 170 186
7/6/2019 08:12:00 50.1 50.0 -70.4 -78.3 200 200 230 170 186
7/6/2019 08:13:00 50.1 50.0 -70.4 -78.3 200 200 230 170 186
7/6/2019 08:14:00 50.2 50.0 -70.4 -78.3 200 200 230 170 186
7/6/2019 08:15:00 50.1 50.0 -70.5 -78.3 200 200 230 170 186
7/6/2019 08:16:00 50.1 50.0 -70.5 -78.3 200 200 230 170 186

-------------------------------------------
Approved by Date Page: 95 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/6/2019 08:17:00 50.0 50.0 -70.5 -78.3 200 200 230 170 186
7/6/2019 08:18:00 49.9 50.0 -70.6 -78.3 200 200 230 170 186
7/6/2019 08:19:00 49.9 50.0 -70.6 -78.4 200 200 230 170 186
7/6/2019 08:20:00 49.9 50.0 -70.6 -78.4 200 200 230 170 186
7/6/2019 08:21:00 50.0 50.0 -70.6 -78.4 200 200 230 170 185
7/6/2019 08:22:00 50.1 50.0 -70.6 -78.4 200 200 230 170 185
7/6/2019 08:23:00 50.1 50.0 -70.7 -78.4 200 200 230 170 185
7/6/2019 08:24:00 50.1 50.0 -70.7 -78.4 200 200 230 170 186
7/6/2019 08:25:00 50.1 50.0 -70.7 -78.4 200 200 230 170 185
7/6/2019 08:26:00 50.0 50.0 -70.7 -78.4 200 200 230 170 185
7/6/2019 08:27:00 50.0 50.0 -70.7 -78.5 200 200 230 170 185
7/6/2019 08:28:00 49.9 50.0 -70.8 -78.5 200 200 230 170 185
7/6/2019 08:29:00 49.9 50.0 -70.8 -78.5 200 200 230 170 185
7/6/2019 08:30:00 49.9 50.0 -70.8 -78.5 200 200 230 170 185
7/6/2019 08:31:00 50.0 50.0 -70.9 -78.5 200 200 230 170 185
7/6/2019 08:32:00 50.0 50.0 -70.8 -78.4 200 200 230 170 185
7/6/2019 08:33:00 50.1 50.0 -70.9 -78.5 200 200 230 170 185
7/6/2019 08:34:00 50.1 50.0 -70.9 -78.5 200 200 230 170 185
7/6/2019 08:35:00 50.1 50.0 -70.9 -78.5 200 200 230 170 185
7/6/2019 08:36:00 50.0 50.0 -71.0 -78.5 200 200 230 170 184
7/6/2019 08:37:00 50.0 50.0 -71.0 -78.6 200 200 230 170 185
7/6/2019 08:38:00 50.0 50.0 -71.0 -78.5 200 200 230 170 184
7/6/2019 08:39:00 50.0 50.0 -71.0 -78.6 200 200 230 170 185
7/6/2019 08:40:00 50.0 50.0 -71.0 -78.6 200 200 230 170 185
7/6/2019 08:41:00 50.0 50.0 -71.0 -78.6 200 200 230 170 184
7/6/2019 08:42:00 50.0 50.0 -71.0 -78.6 200 200 230 170 184
7/6/2019 08:43:00 50.0 50.0 -71.0 -78.6 200 200 230 170 185

-------------------------------------------
Approved by Date Page: 96 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/6/2019 08:44:00 50.0 50.0 -71.0 -78.6 200 200 230 170 184
7/6/2019 08:45:00 50.0 50.0 -71.1 -78.6 200 200 230 170 184
7/6/2019 08:46:00 50.0 50.0 -71.1 -78.6 200 200 230 170 184
7/6/2019 08:47:00 50.0 50.0 -71.1 -78.6 200 200 230 170 184
7/6/2019 08:48:00 50.1 50.0 -71.1 -78.6 200 200 230 170 184
7/6/2019 08:49:00 50.0 50.0 -71.1 -78.6 200 200 230 170 184
7/6/2019 08:50:00 50.0 50.0 -71.1 -78.6 200 200 230 170 184
7/6/2019 08:51:00 50.0 50.0 -71.1 -78.6 200 200 230 170 184
7/6/2019 08:52:00 50.0 50.0 -71.2 -78.6 200 200 230 170 184
7/6/2019 08:53:00 50.0 50.0 -71.2 -78.6 200 200 230 170 184
7/6/2019 08:54:00 50.0 50.0 -71.2 -78.6 200 200 230 170 184
7/6/2019 08:55:00 50.0 50.0 -71.2 -78.6 200 200 230 170 184
7/6/2019 08:56:00 50.0 50.0 -71.2 -78.7 200 200 230 170 184
7/6/2019 08:57:00 50.0 50.0 -71.3 -78.6 199 200 230 170 184
7/6/2019 08:58:00 50.0 50.0 -71.3 -78.7 200 200 230 170 184
7/6/2019 08:59:00 50.0 50.0 -71.3 -78.7 200 200 230 170 184
7/6/2019 09:00:00 50.1 50.0 -71.3 -78.7 200 200 230 170 184
7/6/2019 09:01:00 50.0 50.0 -71.3 -78.7 200 200 230 170 184
7/6/2019 09:02:00 49.9 50.0 -71.3 -78.6 200 200 230 170 184
7/6/2019 09:03:00 49.9 50.0 -71.3 -78.6 200 200 230 170 184
7/6/2019 09:04:00 50.0 50.0 -71.4 -78.7 200 200 230 170 184
7/6/2019 09:05:00 50.0 50.0 -71.4 -78.7 200 200 230 170 184
7/6/2019 09:06:00 50.1 50.0 -71.4 -78.7 200 200 230 170 184
7/6/2019 09:07:00 50.1 50.0 -71.4 -78.7 200 200 230 170 184
7/6/2019 09:08:00 50.0 50.0 -71.4 -78.6 200 200 230 170 184
7/6/2019 09:09:00 50.0 50.0 -71.5 -78.7 200 200 230 170 184
7/6/2019 09:10:00 49.9 50.0 -71.5 -78.7 200 200 230 170 183

-------------------------------------------
Approved by Date Page: 97 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/6/2019 09:11:00 49.9 50.0 -71.5 -78.7 200 200 230 170 184
7/6/2019 09:12:00 50.0 50.0 -71.5 -78.7 200 200 230 170 183
7/6/2019 09:13:00 50.0 50.0 -71.5 -78.7 200 200 230 170 184
7/6/2019 09:14:00 50.0 50.0 -71.5 -78.7 200 200 230 170 184
7/6/2019 09:15:00 50.1 50.0 -71.5 -78.7 200 200 230 170 183
7/6/2019 09:16:00 50.1 50.0 -71.5 -78.7 200 200 230 170 184
7/6/2019 09:17:00 50.0 50.0 -71.5 -78.7 200 200 230 170 183
7/6/2019 09:18:00 50.0 50.0 -71.6 -78.7 200 200 230 170 183
7/6/2019 09:19:00 50.0 50.0 -71.5 -78.7 200 200 230 170 184
7/6/2019 09:20:00 49.9 50.0 -71.5 -78.7 200 200 230 170 183
7/6/2019 09:21:00 50.0 50.0 -71.6 -78.7 200 200 230 170 184
7/6/2019 09:22:00 50.0 50.0 -71.6 -78.7 202 200 230 170 183
7/6/2019 09:23:00 50.1 50.0 -71.6 -78.6 200 200 230 170 183
7/6/2019 09:24:00 50.1 50.0 -71.7 -78.7 200 200 230 170 183
7/6/2019 09:25:00 50.0 50.0 -71.7 -78.6 200 200 230 170 183
7/6/2019 09:26:00 50.0 50.0 -71.7 -78.7 200 200 230 170 183
7/6/2019 09:27:00 50.0 50.0 -71.7 -78.7 200 200 230 170 183
7/6/2019 09:28:00 50.0 50.0 -71.7 -78.6 200 200 230 170 183
7/6/2019 09:29:00 50.0 50.0 -71.7 -78.7 200 200 230 170 183
7/6/2019 09:30:00 49.9 50.0 -71.7 -78.7 200 200 230 170 183
7/6/2019 09:31:00 50.0 50.0 -71.7 -78.6 200 200 230 170 183
7/6/2019 09:32:00 50.0 50.0 -71.7 -78.7 200 200 230 170 183
7/6/2019 09:33:00 50.1 50.0 -71.7 -78.7 200 200 230 170 183
7/6/2019 09:34:00 50.0 50.0 -71.7 -78.7 200 200 230 170 183
7/6/2019 09:35:00 50.0 50.0 -71.8 -78.7 200 200 230 170 183
7/6/2019 09:36:00 50.0 50.0 -71.8 -78.6 200 200 230 170 183
7/6/2019 09:37:00 50.0 50.0 -71.8 -78.6 200 200 230 170 183

-------------------------------------------
Approved by Date Page: 98 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/6/2019 09:38:00 50.0 50.0 -71.8 -78.7 200 200 230 170 183
7/6/2019 09:39:00 49.9 50.0 -71.8 -78.7 200 200 230 170 183
7/6/2019 09:40:00 49.9 50.0 -71.8 -78.6 200 200 230 170 183
7/6/2019 09:41:00 50.0 50.0 -71.8 -78.7 200 200 230 170 183
7/6/2019 09:42:00 50.0 50.0 -71.8 -78.7 200 200 230 170 183
7/6/2019 09:43:00 50.0 50.0 -71.8 -78.7 200 200 230 170 183
7/6/2019 09:44:00 50.0 50.0 -71.8 -78.7 198 200 230 170 183
7/6/2019 09:45:00 50.0 50.0 -71.8 -78.7 200 200 230 170 183
7/6/2019 09:46:00 50.0 50.0 -71.8 -78.7 200 200 230 170 183
7/6/2019 09:47:00 50.0 50.0 -71.8 -78.7 200 200 230 170 183
7/6/2019 09:48:00 50.0 50.0 -71.9 -78.7 200 200 230 170 183
7/6/2019 09:49:00 50.0 50.0 -71.9 -78.7 200 200 230 170 183
7/6/2019 09:50:00 50.0 50.0 -71.9 -78.7 200 200 230 170 183
7/6/2019 09:51:00 50.0 50.0 -71.9 -78.7 200 200 230 170 183
7/6/2019 09:52:00 50.0 50.0 -71.9 -78.7 200 200 230 170 183
7/6/2019 09:53:00 50.0 50.0 -71.9 -78.7 200 200 230 170 183
7/6/2019 09:54:00 50.0 50.0 -71.9 -78.7 200 200 230 170 183
7/6/2019 09:55:00 50.0 50.0 -72.0 -78.7 200 200 230 170 183
7/6/2019 09:56:00 50.0 50.0 -72.0 -78.7 200 200 230 170 183
7/6/2019 09:57:00 50.0 50.0 -72.0 -78.7 200 200 230 170 183
7/6/2019 09:58:00 50.0 50.0 -72.0 -78.7 200 200 230 170 183
7/6/2019 09:59:00 50.0 50.0 -71.9 -78.7 200 200 230 170 183
7/6/2019 10:00:00 50.0 50.0 -72.0 -78.7 200 200 230 170 183
7/6/2019 10:01:00 50.0 50.0 -72.0 -78.7 200 200 230 170 183
7/6/2019 10:02:00 50.0 50.0 -72.0 -78.7 200 200 230 170 182
7/6/2019 10:03:00 50.0 50.0 -72.0 -78.7 200 200 230 170 183
7/6/2019 10:04:00 50.0 50.0 -72.0 -78.7 200 200 230 170 182

-------------------------------------------
Approved by Date Page: 99 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/6/2019 10:05:00 50.0 50.0 -72.0 -78.7 200 200 230 170 183
7/6/2019 10:06:00 50.0 50.0 -72.1 -78.7 200 200 230 170 183
7/6/2019 10:07:00 49.9 50.0 -72.1 -78.7 200 200 230 170 183
7/6/2019 10:08:00 50.0 50.0 -72.1 -78.7 200 200 230 170 183
7/6/2019 10:09:00 50.1 50.0 -72.1 -78.7 200 200 230 170 183
7/6/2019 10:10:00 50.0 50.0 -72.1 -78.7 201 200 230 170 183
7/6/2019 10:11:00 50.0 50.0 -72.1 -78.7 200 200 230 170 183
7/6/2019 10:12:00 50.0 50.0 -72.1 -78.7 200 200 230 170 183
7/6/2019 10:13:00 50.0 50.0 -72.1 -78.7 200 200 230 170 182
7/6/2019 10:14:00 50.0 50.0 -72.1 -78.7 200 200 230 170 183
7/6/2019 10:15:00 50.0 50.0 -72.1 -78.7 200 200 230 170 182
7/6/2019 10:16:00 50.0 50.0 -72.1 -78.7 200 200 230 170 183
7/6/2019 10:17:00 50.0 50.0 -72.1 -78.7 200 200 230 170 183
7/6/2019 10:18:00 50.0 50.0 -72.2 -78.8 200 200 230 170 183
7/6/2019 10:19:00 50.0 50.0 -72.2 -78.7 200 200 230 170 183
7/6/2019 10:19:14 Alarm: CLOSE - COM2 motor over temperature.
7/6/2019 10:19:47 Audit: - A_COM2MOTORHT ALARM is acknowledged by IDIN.
7/6/2019 10:19:48 Audit: - Alarm is reset manually by IDIN.
7/6/2019 10:20:00 50.0 50.0 -72.1 -78.7 200 200 230 170 182
7/6/2019 10:21:00 50.0 50.0 -72.2 -78.8 200 200 230 170 183
7/6/2019 10:22:00 50.0 50.0 -72.3 -78.8 200 200 230 170 183
7/6/2019 10:23:00 50.0 50.0 -72.4 -78.7 200 200 230 170 182
7/6/2019 10:24:00 50.0 50.0 -72.4 -78.7 200 200 230 170 183
7/6/2019 10:25:00 50.0 50.0 -72.5 -78.7 200 200 230 170 182
7/6/2019 10:26:00 50.0 50.0 -72.5 -78.7 200 200 230 170 182
7/6/2019 10:27:00 50.0 50.0 -72.5 -78.7 200 200 230 170 183
7/6/2019 10:28:00 50.0 50.0 -72.5 -78.7 200 200 230 170 182

-------------------------------------------
Approved by Date Page: 100 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/6/2019 10:29:00 50.0 50.0 -72.5 -78.8 200 200 230 170 183
7/6/2019 10:30:00 50.0 50.0 -72.4 -78.8 200 200 230 170 182
7/6/2019 10:31:00 50.0 50.0 -72.4 -78.8 200 200 230 170 183
7/6/2019 10:32:00 50.0 50.0 -72.5 -78.7 200 200 230 170 182
7/6/2019 10:33:00 50.0 50.0 -72.5 -78.7 200 200 230 170 182
7/6/2019 10:34:00 50.0 50.0 -72.5 -78.8 200 200 230 170 183
7/6/2019 10:35:00 50.0 50.0 -72.6 -78.8 200 200 230 170 182
7/6/2019 10:36:00 50.0 50.0 -72.5 -78.7 200 200 230 170 183
7/6/2019 10:37:00 50.0 50.0 -72.5 -78.7 200 200 230 170 183
7/6/2019 10:38:00 50.0 50.0 -72.5 -78.7 200 200 230 170 183
7/6/2019 10:39:00 50.0 50.0 -72.5 -78.7 200 200 230 170 182
7/6/2019 10:40:00 50.0 50.0 -72.4 -78.7 200 200 230 170 183
7/6/2019 10:41:00 50.0 50.0 -72.4 -78.7 200 200 230 170 183
7/6/2019 10:42:00 50.0 50.0 -72.4 -78.7 200 200 230 170 183
7/6/2019 10:43:00 50.0 50.0 -72.4 -78.7 200 200 230 170 182
7/6/2019 10:44:00 50.0 50.0 -72.4 -78.7 200 200 230 170 183
7/6/2019 10:45:00 50.0 50.0 -72.4 -78.7 200 200 230 170 183
7/6/2019 10:46:00 50.0 50.0 -72.4 -78.7 200 200 230 170 183
7/6/2019 10:47:00 50.0 50.0 -72.5 -78.7 202 200 230 170 183
7/6/2019 10:48:00 50.0 50.0 -72.4 -78.7 200 200 230 170 182
7/6/2019 10:49:00 50.0 50.0 -72.5 -78.7 200 200 230 170 183
7/6/2019 10:50:00 50.0 50.0 -72.4 -78.7 200 200 230 170 182
7/6/2019 10:51:00 50.0 50.0 -72.4 -78.7 200 200 230 170 183
7/6/2019 10:52:00 50.0 50.0 -72.4 -78.7 202 200 230 170 183
7/6/2019 10:53:00 50.0 50.0 -72.4 -78.7 200 200 230 170 182
7/6/2019 10:54:00 50.0 50.0 -72.4 -78.7 200 200 230 170 183
7/6/2019 10:55:00 50.0 50.0 -72.4 -78.7 200 200 230 170 182

-------------------------------------------
Approved by Date Page: 101 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/6/2019 10:56:00 50.0 50.0 -72.4 -78.7 200 200 230 170 183
7/6/2019 10:57:00 50.0 50.0 -72.5 -78.7 200 200 230 170 182
7/6/2019 10:58:00 50.0 50.0 -72.5 -78.7 200 200 230 170 183
7/6/2019 10:59:00 50.0 50.0 -72.5 -78.7 200 200 230 170 183
7/6/2019 11:00:00 50.0 50.0 -72.5 -78.7 200 200 230 170 182
7/6/2019 11:01:00 50.0 50.0 -72.5 -78.7 200 200 230 170 183
7/6/2019 11:02:00 50.0 50.0 -72.5 -78.7 200 200 230 170 182
7/6/2019 11:03:00 50.0 50.0 -72.5 -78.7 200 200 230 170 183
7/6/2019 11:04:00 50.0 50.0 -72.5 -78.7 200 200 230 170 183
7/6/2019 11:05:00 50.0 50.0 -72.5 -78.7 200 200 230 170 182
7/6/2019 11:06:00 50.0 50.0 -72.5 -78.7 200 200 230 170 183
7/6/2019 11:07:00 50.0 50.0 -72.5 -78.7 200 200 230 170 182
7/6/2019 11:08:00 50.0 50.0 -72.5 -78.7 200 200 230 170 183
7/6/2019 11:09:00 50.0 50.0 -72.5 -78.7 200 200 230 170 182
7/6/2019 11:10:00 50.0 50.0 -72.5 -78.7 200 200 230 170 183
7/6/2019 11:11:00 50.0 50.0 -72.6 -78.7 200 200 230 170 182
7/6/2019 11:12:00 50.0 50.0 -72.6 -78.7 200 200 230 170 183
7/6/2019 11:13:00 50.0 50.0 -72.6 -78.7 200 200 230 170 182
7/6/2019 11:14:00 50.0 50.0 -72.6 -78.7 200 200 230 170 183
7/6/2019 11:15:00 50.0 50.0 -72.6 -78.7 200 200 230 170 183
7/6/2019 11:16:00 50.0 50.0 -72.6 -78.8 200 200 230 170 182
7/6/2019 11:17:00 50.0 50.0 -72.6 -78.8 200 200 230 170 183
7/6/2019 11:18:00 50.0 50.0 -72.6 -78.8 200 200 230 170 182
7/6/2019 11:19:00 50.0 50.0 -72.6 -78.7 200 200 230 170 183
7/6/2019 11:20:00 50.0 50.0 -72.6 -78.8 200 200 230 170 183
7/6/2019 11:21:00 50.0 50.0 -72.6 -78.8 200 200 230 170 183
7/6/2019 11:22:00 50.0 50.0 -72.6 -78.8 200 200 230 170 183

-------------------------------------------
Approved by Date Page: 102 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/6/2019 11:23:00 50.0 50.0 -72.7 -78.8 200 200 230 170 183
7/6/2019 11:24:00 50.0 50.0 -72.7 -78.8 200 200 230 170 182
7/6/2019 11:25:00 50.0 50.0 -72.6 -78.8 200 200 230 170 182
7/6/2019 11:26:00 50.0 50.0 -72.7 -78.8 200 200 230 170 183
7/6/2019 11:27:00 50.0 50.0 -72.7 -78.8 200 200 230 170 183
7/6/2019 11:28:00 50.0 50.0 -72.7 -78.8 200 200 230 170 183
7/6/2019 11:29:00 50.1 50.0 -72.7 -78.8 200 200 230 170 182
7/6/2019 11:30:00 50.0 50.0 -72.7 -78.8 200 200 230 170 183
7/6/2019 11:31:00 50.0 50.0 -72.7 -78.9 200 200 230 170 182
7/6/2019 11:32:00 50.0 50.0 -72.7 -78.8 200 200 230 170 183
7/6/2019 11:33:00 50.0 50.0 -72.7 -78.8 200 200 230 170 182
7/6/2019 11:34:00 50.1 50.0 -72.8 -78.8 200 200 230 170 183
7/6/2019 11:35:00 50.0 50.0 -72.8 -78.8 200 200 230 170 182
7/6/2019 11:36:00 50.0 50.0 -72.7 -78.8 200 200 230 170 183
7/6/2019 11:37:00 50.1 50.0 -72.7 -78.9 200 200 230 170 182
7/6/2019 11:38:00 50.0 50.0 -72.7 -78.8 200 200 230 170 183
7/6/2019 11:39:00 50.1 50.0 -72.8 -78.8 200 200 230 170 183
7/6/2019 11:40:00 50.0 50.0 -72.7 -78.7 200 200 230 170 183
7/6/2019 11:41:00 50.0 50.0 -72.8 -78.6 200 200 230 170 182
7/6/2019 11:42:00 50.0 50.0 -72.8 -78.4 200 200 230 170 183
7/6/2019 11:43:00 50.0 50.0 -72.8 -78.3 200 200 230 170 183
7/6/2019 11:44:00 50.0 50.0 -72.8 -78.3 200 200 230 170 183
7/6/2019 11:45:00 50.0 50.0 -72.8 -78.4 200 200 230 170 183
7/6/2019 11:46:00 50.0 50.0 -72.8 -78.4 200 200 230 170 182
7/6/2019 11:47:00 50.0 50.0 -72.8 -78.5 200 200 230 170 182
7/6/2019 11:48:00 50.0 50.0 -72.8 -78.5 200 200 230 170 183
7/6/2019 11:49:00 50.0 50.0 -72.8 -78.6 200 200 230 170 183

-------------------------------------------
Approved by Date Page: 103 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/6/2019 11:50:00 50.0 50.0 -72.8 -78.6 200 200 230 170 183
7/6/2019 11:51:00 50.0 50.0 -72.8 -78.6 200 200 230 170 183
7/6/2019 11:52:00 50.0 50.0 -72.8 -78.7 200 200 230 170 183
7/6/2019 11:53:00 50.0 50.0 -72.8 -78.7 200 200 230 170 183
7/6/2019 11:54:00 50.0 50.0 -72.8 -78.7 200 200 230 170 183
7/6/2019 11:55:00 50.0 50.0 -72.8 -78.7 200 200 230 170 183
7/6/2019 11:56:00 50.0 50.0 -72.8 -78.8 200 200 230 170 183
7/6/2019 11:57:00 50.0 50.0 -72.8 -78.8 200 200 230 170 183
7/6/2019 11:58:00 50.0 50.0 -72.8 -78.8 200 200 230 170 183
7/6/2019 11:59:00 50.0 50.0 -72.8 -78.8 200 200 230 170 183
7/6/2019 12:00:00 50.0 50.0 -72.9 -78.7 200 200 230 170 183
7/6/2019 12:01:00 50.0 50.0 -72.9 -78.6 200 200 230 170 183
7/6/2019 12:02:00 50.0 50.0 -72.9 -78.6 200 200 230 170 183
7/6/2019 12:03:00 50.0 50.0 -72.8 -78.6 200 200 230 170 183
7/6/2019 12:04:00 50.0 50.0 -72.8 -78.6 200 200 230 170 183
7/6/2019 12:05:00 50.0 50.0 -72.9 -78.7 200 200 230 170 183
7/6/2019 12:06:00 50.0 50.0 -72.9 -78.7 200 200 230 170 183
7/6/2019 12:07:00 50.0 50.0 -72.9 -78.7 200 200 230 170 183
7/6/2019 12:08:00 50.0 50.0 -72.9 -78.7 200 200 230 170 183
7/6/2019 12:09:00 50.0 50.0 -72.9 -78.7 200 200 230 170 183
7/6/2019 12:10:00 50.0 50.0 -72.9 -78.6 200 200 230 170 183
7/6/2019 12:11:00 50.0 50.0 -72.9 -78.6 200 200 230 170 183
7/6/2019 12:12:00 50.0 50.0 -72.9 -78.6 200 200 230 170 183
7/6/2019 12:13:00 50.0 50.0 -72.9 -78.6 200 200 230 170 183
7/6/2019 12:14:00 50.0 50.0 -72.9 -78.6 200 200 230 170 183
7/6/2019 12:15:00 50.0 50.0 -72.9 -78.7 200 200 230 170 183
7/6/2019 12:16:00 50.0 50.0 -72.9 -78.7 200 200 230 170 183

-------------------------------------------
Approved by Date Page: 104 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/6/2019 12:17:00 50.0 50.0 -72.9 -78.7 200 200 230 170 183
7/6/2019 12:18:00 50.0 50.0 -72.9 -78.7 200 200 230 170 183
7/6/2019 12:19:00 50.0 50.0 -72.9 -78.6 200 200 230 170 183
7/6/2019 12:20:00 50.0 50.0 -72.9 -78.6 200 200 230 170 183
7/6/2019 12:21:00 50.0 50.0 -72.9 -78.6 200 200 230 170 183
7/6/2019 12:22:00 50.0 50.0 -72.9 -78.6 200 200 230 170 183
7/6/2019 12:23:00 50.0 50.0 -72.9 -78.6 200 200 230 170 183
7/6/2019 12:24:00 50.0 50.0 -72.9 -78.7 200 200 230 170 183
7/6/2019 12:25:00 50.0 50.0 -72.9 -78.7 200 200 230 170 183
7/6/2019 12:26:00 50.0 50.0 -73.0 -78.6 200 200 230 170 183
7/6/2019 12:27:00 50.0 50.0 -73.0 -78.6 200 200 230 170 183
7/6/2019 12:28:00 50.0 50.0 -72.9 -78.5 200 200 230 170 183
7/6/2019 12:29:00 50.0 50.0 -72.9 -78.6 200 200 230 170 183
7/6/2019 12:30:00 50.0 50.0 -72.9 -78.6 200 200 230 170 183
7/6/2019 12:31:00 50.0 50.0 -72.9 -78.6 200 200 230 170 183
7/6/2019 12:32:00 50.0 50.0 -72.9 -78.6 200 200 230 170 183
7/6/2019 12:33:00 50.0 50.0 -73.0 -78.7 200 200 230 170 183
7/6/2019 12:34:00 50.0 50.0 -72.9 -78.7 200 200 230 170 183
7/6/2019 12:35:00 50.0 50.0 -73.0 -78.6 200 200 230 170 183
7/6/2019 12:36:00 50.0 50.0 -73.0 -78.5 200 200 230 170 183
7/6/2019 12:37:00 50.0 50.0 -73.0 -78.5 200 200 230 170 183
7/6/2019 12:38:00 50.0 50.0 -73.0 -78.5 200 200 230 170 183
7/6/2019 12:39:00 50.0 50.0 -73.0 -78.6 200 200 230 170 183
7/6/2019 12:40:00 50.0 50.0 -73.0 -78.6 200 200 230 170 183
7/6/2019 12:41:00 50.1 50.0 -73.0 -78.6 200 200 230 170 183
7/6/2019 12:42:00 50.0 50.0 -73.0 -78.6 200 200 230 170 183
7/6/2019 12:43:00 50.0 50.0 -73.0 -78.6 200 200 230 170 183

-------------------------------------------
Approved by Date Page: 105 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/6/2019 12:44:00 50.0 50.0 -73.0 -78.5 200 200 230 170 183
7/6/2019 12:45:00 50.0 50.0 -73.0 -78.5 200 200 230 170 183
7/6/2019 12:46:00 50.0 50.0 -73.0 -78.5 200 200 230 170 183
7/6/2019 12:47:00 50.0 50.0 -73.0 -78.5 200 200 230 170 183
7/6/2019 12:48:00 50.0 50.0 -73.0 -78.6 200 200 230 170 183
7/6/2019 12:49:00 50.0 50.0 -73.0 -78.6 200 200 230 170 183
7/6/2019 12:50:00 50.1 50.0 -73.0 -78.6 200 200 230 170 183
7/6/2019 12:51:00 50.0 50.0 -73.0 -78.6 200 200 230 170 183
7/6/2019 12:52:00 50.0 50.0 -73.0 -78.5 200 200 230 170 183
7/6/2019 12:53:00 50.0 50.0 -73.0 -78.5 200 200 230 170 183
7/6/2019 12:54:00 50.0 50.0 -73.0 -78.5 200 200 230 170 183
7/6/2019 12:55:00 50.0 50.0 -73.0 -78.5 200 200 230 170 183
7/6/2019 12:56:00 50.0 50.0 -73.0 -78.5 200 200 230 170 183
7/6/2019 12:57:00 50.0 50.0 -73.0 -78.6 200 200 230 170 183
7/6/2019 12:58:00 50.0 50.0 -73.0 -78.6 200 200 230 170 183
7/6/2019 12:59:00 50.0 50.0 -73.0 -78.5 200 200 230 170 183
7/6/2019 13:00:00 50.0 50.0 -73.1 -78.5 200 200 230 170 183
7/6/2019 13:01:00 50.0 50.0 -73.0 -78.5 200 200 230 170 183
7/6/2019 13:02:00 50.0 50.0 -73.1 -78.6 200 200 230 170 182
7/6/2019 13:03:00 50.0 50.0 -73.0 -78.6 200 200 230 170 183
7/6/2019 13:04:00 50.0 50.0 -73.0 -78.6 200 200 230 170 183
7/6/2019 13:05:00 50.0 50.0 -73.0 -78.6 200 200 230 170 183
7/6/2019 13:06:00 50.0 50.0 -73.1 -78.4 200 200 230 170 183
7/6/2019 13:07:00 50.0 50.0 -73.1 -78.4 200 200 230 170 183
7/6/2019 13:08:00 50.0 50.0 -73.1 -78.4 200 200 230 170 183
7/6/2019 13:09:00 50.0 50.0 -73.1 -78.5 200 200 230 170 183
7/6/2019 13:10:00 50.0 50.0 -73.1 -78.5 200 200 230 170 183

-------------------------------------------
Approved by Date Page: 106 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/6/2019 13:11:00 50.0 50.0 -73.1 -78.6 200 200 230 170 183
7/6/2019 13:12:00 50.0 50.0 -73.0 -78.6 200 200 230 170 183
7/6/2019 13:13:00 50.0 50.0 -73.1 -78.6 200 200 230 170 183
7/6/2019 13:14:00 50.0 50.0 -73.1 -78.7 200 200 230 170 183
7/6/2019 13:15:00 50.0 50.0 -73.1 -78.7 200 200 230 170 184
7/6/2019 13:16:00 50.0 50.0 -73.1 -78.6 200 200 230 170 184
7/6/2019 13:17:00 50.0 50.0 -73.1 -78.5 200 200 230 170 184
7/6/2019 13:18:00 50.0 50.0 -73.1 -78.5 200 200 230 170 184
7/6/2019 13:19:00 50.0 50.0 -73.1 -78.6 200 200 230 170 184
7/6/2019 13:20:00 50.0 50.0 -73.1 -78.6 200 200 230 170 184
7/6/2019 13:21:00 50.0 50.0 -73.1 -78.6 200 200 230 170 184
7/6/2019 13:22:00 50.0 50.0 -73.1 -78.6 200 200 230 170 184
7/6/2019 13:23:00 50.0 50.0 -73.1 -78.7 200 200 230 170 184
7/6/2019 13:24:00 50.0 50.0 -73.1 -78.7 200 200 230 170 184
7/6/2019 13:25:00 50.0 50.0 -73.1 -78.7 200 200 230 170 184
7/6/2019 13:26:00 50.0 50.0 -73.1 -78.8 200 200 230 170 184
7/6/2019 13:27:00 50.1 50.0 -73.1 -78.8 200 200 230 170 184
7/6/2019 13:28:00 50.0 50.0 -73.1 -78.7 200 200 230 170 184
7/6/2019 13:29:00 50.0 50.0 -73.1 -78.6 200 200 230 170 184
7/6/2019 13:30:00 50.0 50.0 -73.1 -78.6 200 200 230 170 184
7/6/2019 13:31:00 50.0 50.0 -73.1 -78.6 200 200 230 170 184
7/6/2019 13:32:00 50.0 50.0 -73.1 -78.6 200 200 230 170 184
7/6/2019 13:33:00 50.0 50.0 -73.1 -78.7 200 200 230 170 185
7/6/2019 13:34:00 50.0 50.0 -73.1 -78.7 200 200 230 170 185
7/6/2019 13:35:00 50.0 50.0 -73.1 -78.7 200 200 230 170 185
7/6/2019 13:36:00 50.0 50.0 -73.1 -78.8 200 200 230 170 185
7/6/2019 13:37:00 50.0 50.0 -73.1 -78.8 200 200 230 170 184

-------------------------------------------
Approved by Date Page: 107 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/6/2019 13:38:00 50.0 50.0 -73.1 -78.8 200 200 230 170 185
7/6/2019 13:39:00 50.0 50.0 -73.1 -78.9 200 200 230 170 185
7/6/2019 13:40:00 50.0 50.0 -73.1 -78.7 200 200 230 170 185
7/6/2019 13:41:00 50.0 50.0 -73.1 -78.7 200 200 230 170 185
7/6/2019 13:42:00 50.0 50.0 -73.1 -78.7 200 200 230 170 185
7/6/2019 13:43:00 50.0 50.0 -73.1 -78.7 200 200 230 170 185
7/6/2019 13:44:00 50.0 50.0 -73.1 -78.7 200 200 230 170 185
7/6/2019 13:45:00 50.0 50.0 -73.2 -78.8 200 200 230 170 185
7/6/2019 13:46:00 50.0 50.0 -73.1 -78.8 200 200 230 170 185
7/6/2019 13:47:00 50.0 50.0 -73.2 -78.8 200 200 230 170 185
7/6/2019 13:48:00 50.0 50.0 -73.1 -78.8 200 200 230 170 185
7/6/2019 13:49:00 50.0 50.0 -73.2 -78.9 200 200 230 170 185
7/6/2019 13:50:00 50.0 50.0 -73.2 -78.9 200 200 230 170 185
7/6/2019 13:51:00 50.0 50.0 -73.2 -78.9 200 200 230 170 185
7/6/2019 13:52:00 50.0 50.0 -73.2 -78.8 200 200 230 170 185
7/6/2019 13:53:00 50.0 50.0 -73.2 -78.8 200 200 230 170 185
7/6/2019 13:54:00 50.0 50.0 -73.2 -78.8 200 200 230 170 185
7/6/2019 13:55:00 50.0 50.0 -73.2 -78.8 200 200 230 170 185
7/6/2019 13:56:00 50.0 50.0 -73.2 -78.8 200 200 230 170 186
7/6/2019 13:57:00 50.0 50.0 -73.2 -78.8 200 200 230 170 185
7/6/2019 13:58:00 50.0 50.0 -73.2 -78.8 200 200 230 170 185
7/6/2019 13:59:00 50.0 50.0 -73.2 -78.9 200 200 230 170 186
7/6/2019 14:00:00 50.0 50.0 -73.2 -78.9 200 200 230 170 185
7/6/2019 14:00:30 Event: - Step advanced to [11] Moisture Test
7/6/2019 14:00:35 Event: - The pressure rise test is started.
7/6/2019 14:01:00 50.0 50.0 -73.2 -78.8 175 200 230 170 11
7/6/2019 14:01:50 Event: - Pressure rise test passed.Pressure rise test setpoint value is [10µBar] Pressure rise test setpoint time is

-------------------------------------------
Approved by Date Page: 108 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
[60Sec.] The final chamber vacuum rise in this test is [2µBar] Pressure rise test process time is [60Sec.]
Event: - Step advanced to [12] Pre-aeration
7/6/2019 14:02:00 50.0 50.0 -73.2 -78.8 - - 230 170 6
7/6/2019 14:03:00 50.0 50.0 -73.2 -78.9 - - 230 170 5
7/6/2019 14:04:00 50.0 50.0 -73.2 -79.0 - - 230 170 5
7/6/2019 14:05:00 49.9 50.0 -73.2 -79.2 - - 230 170 4
7/6/2019 14:05:05 Event: - Step advanced to [13] Stoppering
7/6/2019 14:06:00 49.9 50.0 -73.2 -79.4 - - 230 170 4
7/6/2019 14:07:00 49.9 50.0 -73.2 -79.7 - - 230 170 4
7/6/2019 14:08:00 49.8 50.0 -73.2 -80.1 - - 230 170 4
7/6/2019 14:08:10 Event: - Step advanced to [14] Aeration
7/6/2019 14:09:00 50.0 50.0 -73.3 -80.2 - - 230 170 4
7/6/2019 14:10:00 50.1 50.0 -73.3 -80.1 - - 230 170 4
7/6/2019 14:11:00 50.2 50.0 -73.3 -79.9 - - 230 170 4
7/6/2019 14:12:00 50.1 50.0 -73.3 -79.8 - - 230 170 3
7/6/2019 14:13:00 50.1 50.0 -73.4 -79.7 - - 230 170 3
7/6/2019 14:14:00 50.0 50.0 -73.4 -79.6 - - 230 170 3
7/6/2019 14:15:00 50.0 50.0 -73.4 -79.5 - - 230 170 2
7/6/2019 14:16:00 49.9 50.0 -73.4 -79.3 - - 230 170 2
7/6/2019 14:17:00 49.9 50.0 -72.1 -78.6 - - 230 170 2
7/6/2019 14:18:00 49.9 50.0 -71.3 -76.9 - - 230 170 2
7/6/2019 14:19:00 50.0 50.0 -70.1 -74.8 - - 230 170 2
7/6/2019 14:20:00 50.0 50.0 -69.1 -72.7 - - 230 170 2
7/6/2019 14:21:00 50.1 50.0 -67.7 -70.6 - - 230 170 2
7/6/2019 14:22:00 50.1 50.0 -66.7 -69.0 - - 230 170 2
7/6/2019 14:23:00 50.1 50.0 -65.4 -67.2 - - 230 170 2
7/6/2019 14:24:00 50.0 50.0 -63.9 -65.1 - - 230 170 2

-------------------------------------------
Approved by Date Page: 109 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/6/2019 14:25:00 49.9 50.0 -62.9 -63.0 - - 230 170 2
7/6/2019 14:26:00 49.9 50.0 -61.8 -61.0 - - 230 170 2
7/6/2019 14:27:00 50.0 50.0 -60.7 -59.1 - - 230 170 2
7/6/2019 14:28:00 50.0 50.0 -59.7 -57.7 - - 230 170 34
7/6/2019 14:29:00 50.0 50.0 -58.8 -56.5 - - 230 170 37
7/6/2019 14:30:00 50.0 50.0 -57.9 -55.4 - - 230 170 40
7/6/2019 14:31:00 50.0 50.0 -57.0 -54.5 - - 230 170 43
7/6/2019 14:31:27 Audit: - Trend.grpDuration.strDuration.CurrentValue set to 30 by IDIN.
7/6/2019 14:32:00 50.0 50.0 -56.2 -53.6 - - 230 170 46
7/6/2019 14:32:10 Event: - Step advanced to [15] Storage
7/6/2019 14:33:00 47.9 20.0 -55.4 -52.9 - - 230 170 49
7/6/2019 14:34:00 46.6 20.0 -54.7 -52.1 - - 230 170 52
7/6/2019 14:35:00 45.4 20.0 -54.1 -51.4 - - 230 170 54
7/6/2019 14:36:00 44.0 20.0 -53.4 -50.7 - - 230 170 57
7/6/2019 14:37:00 42.4 20.0 -52.6 -50.0 - - 230 170 60
7/6/2019 14:38:00 41.4 20.0 -51.9 -49.3 - - 230 170 62
7/6/2019 14:39:00 40.3 20.0 -51.3 -48.7 - - 230 170 65
7/6/2019 14:40:00 38.7 20.0 -50.4 -48.1 - - 230 170 67
7/6/2019 14:41:00 37.7 20.0 -49.5 -47.5 - - 230 170 70
7/6/2019 14:42:00 36.7 20.0 -48.8 -46.9 - - 230 170 73
7/6/2019 14:43:00 35.1 20.0 -48.2 -46.3 - - 230 170 75
7/6/2019 14:44:00 34.1 20.0 -47.4 -45.8 - - 230 170 78
7/6/2019 14:45:00 33.2 20.0 -46.2 -45.2 - - 230 170 80
7/6/2019 14:46:00 31.7 20.0 -44.6 -44.8 - - 230 170 82
7/6/2019 14:47:00 30.7 20.0 -43.4 -44.3 - - 230 170 85
7/6/2019 14:48:00 29.9 20.0 -43.1 -43.8 - - 230 170 88
7/6/2019 14:49:00 28.6 20.0 -42.7 -43.3 - - 230 170 91

-------------------------------------------
Approved by Date Page: 110 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section3:Operation Parameters

Shelf Condenser Condenser Control Control


Shelf Chamber Control Pump
inlet coil1 coil2 vacuum vacuum
control vacuum vacuum vacuum
Date/Time temperature temperature temperature high low
temperature PT101 setpoint PT301
TE201 TE203 TE204 limit limit
(°C) (µBar) (µBar) (µBar)
(°C) (°C) (°C) (µBar) (µBar)
7/6/2019 14:50:00 27.5 20.0 -42.3 -43.0 - - 230 170 93
7/6/2019 14:51:00 26.7 20.0 -41.9 -42.5 - - 230 170 96
7/6/2019 14:51:40 Alarm: CLOSE - COM1 motor over temperature.
Alarm: CLOSE - Compressor 1 failure.
7/6/2019 14:52:00 26.9 20.0 -41.3 -42.1 - - 230 170 98
7/6/2019 14:53:00 26.6 20.0 -40.9 -41.7 - - 230 170 101
7/6/2019 14:54:00 26.9 20.0 -40.4 -41.4 - - 230 170 104
7/6/2019 14:55:00 26.9 20.0 -39.9 -41.0 - - 230 170 106
7/6/2019 14:56:00 26.2 20.0 -39.6 -40.6 - - 230 170 109
7/6/2019 14:57:00 26.4 20.0 -39.2 -40.3 - - 230 170 111
7/6/2019 14:58:00 26.3 20.0 -38.8 -39.9 - - 230 170 114
7/6/2019 14:59:00 25.7 20.0 -38.5 -39.6 - - 230 170 116
7/6/2019 15:00:00 25.8 20.0 -38.1 -39.3 - - 230 170 119
7/6/2019 15:01:00 25.9 20.0 -37.8 -39.0 - - 230 170 121
7/6/2019 15:02:00 25.3 20.0 -37.5 -38.7 - - 230 170 124
7/6/2019 15:03:00 25.2 20.0 -37.2 -38.4 - - 230 170 126
7/6/2019 15:04:00 25.3 20.0 -37.0 -38.1 - - 230 170 130
7/6/2019 15:05:00 24.6 20.0 -36.7 -37.8 - - 230 170 132
7/6/2019 15:06:00 24.5 20.0 -36.4 -37.6 - - 230 170 135
7/6/2019 15:07:00 24.6 20.0 -36.2 -37.2 - - 230 170 137
7/6/2019 15:07:09 Audit: - The freeze drying cycle is advanced to the next step by IDIN.
7/6/2019 15:07:10 Event: - Auto freeze drying advanced to next step.
7/6/2019 15:07:15 24.5 20.0 -36.2 -37.2 - - 230 170 138
Event: - Auto freeze drying cycle ended.

-------------------------------------------
Approved by Date Page: 111 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section4:History trend
4-1 AFD-1
Chamber vacuum Chamber vacuum PT102 Control vacuum setpoint Shelf inlet temperature
Shelf outlet temperature Shelf control temperature Condenser coil1 temperature Condenser coil2 temperature
1000 200

900

150
800

700
100

600
µBar

C
500 50

400

0
300

200
-50

100

0 -100
7/4/2019 7/4/2019 7/5/2019 7/5/2019 7/5/2019 7/5/2019 7/5/2019 7/6/2019 7/6/2019 7/6/2019
15:50 20:40 1:25 6:10 10:55 15:40 20:25 1:10 5:55 10:40
Date/Time(M/D/YYYY HH:MM:SS)

-------------------------------------------
Approved by Date Page: 112 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section4:History trend
4-2 AFD-2
Product temperature TE101 Product temperature TE102 Product temperature TE103
Product temperature TE104 Product temperature TE105
200

150

100
C

50

-50

-100
7/4/2019 7/4/2019 7/5/2019 7/5/2019 7/5/2019 7/5/2019 7/5/2019 7/6/2019 7/6/2019 7/6/2019
15:50:00 20:40:00 01:25:00 06:10:00 10:55:00 15:40:00 20:25:00 01:10:00 05:55:00 10:40:00
Date/Time(M/D/YYYY HH:MM:SS)

-------------------------------------------
Approved by Date Page: 113 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name

Section4:History trend
4-3 AFD-3
Product temperature TE106 Product temperature TE107 Product temperature TE108
Product temperature TE109 Product temperature TE110
200

150

100
C

50

-50

-100
7/4/2019 7/4/2019 7/5/2019 7/5/2019 7/5/2019 7/5/2019 7/5/2019 7/6/2019 7/6/2019 7/6/2019
15:50:00 20:40:00 01:25:00 06:10:00 10:55:00 15:40:00 20:25:00 01:10:00 05:55:00 10:40:00
Date/Time(M/D/YYYY HH:MM:SS)

-------------------------------------------
Approved by Date Page: 114 of 114

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