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PT. KALBE FARMA TBK.

AUTO FREEZE DRYING Batch Report


Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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 40mg
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 AFD20190624160819
11 Batch Series Number 1273
12 Batch Comments Pranza 40mg BN (VPRZA90058)
13 Batch Description 24-Jun-19
14 Batch Start Time 6/24/2019 16:08
15 Batch End Time 6/26/2019 8:18
16 Batch End Mode Normal
17 Report template name VIT_AFD

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Approved by Date Page: 1 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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).

-------------------------------------------
Approved by Date Page: 2 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/24/2019 16:06:00 4.5 5.0 29.4 28.8 - 30 80 0 -
6/24/2019 16:07:00 5.2 5.0 29.4 28.8 - 30 80 0 -
6/24/2019 16:08:03 Audit: - Manual shelf temperature regulation is disabled by IDIN.
6/24/2019 16:08:09 Audit: - Manual control mode is de-activated by IDIN.
6/24/2019 16:08:11 Audit: - Auto control mode is activated by IDIN.
6/24/2019 16:08:18 Audit: - The auto freeze drying is started by IDIN.
6/24/2019 16:09:30 Alarm: CLOSE - Heater failure.
6/24/2019 16:10:10 Alarm: CLOSE - Heater failure.
6/24/2019 16:10:30 Alarm: CLOSE - Heater failure.
6/24/2019 16:10:45 Event: - Step advanced to [1] Loading
6/24/2019 16:10:50 Audit: - Slave panel is enabled by IDIN.
6/24/2019 16:10:59 Audit: - A_HTRFAIL ALARM is acknowledged by IDIN.
6/24/2019 16:11:00 5.1 5.0 29.2 28.5 - - 80 0 -
6/24/2019 16:12:00 4.9 5.0 29.2 28.5 - - 80 0 -
6/24/2019 16:13:00 5.3 5.0 29.2 28.5 - - 80 0 -
6/24/2019 16:14:00 4.9 5.0 29.1 28.5 - - 80 0 -
6/24/2019 16:15:00 5.2 5.0 29.2 28.4 - - 80 0 -
6/24/2019 16:16:00 4.9 5.0 29.2 28.5 - - 80 0 -
6/24/2019 16:17:00 5.3 5.0 29.1 28.4 - - 80 0 -
6/24/2019 16:17:51 Alarm: CLOSE - Heater failure.
6/24/2019 16:18:00 4.9 5.0 29.1 28.4 - - 80 0 -
Audit: - A_HTRFAIL ALARM is acknowledged by IDIN.
6/24/2019 16:18:05 Audit: - Alarm is reset manually by IDIN.
6/24/2019 16:18:10 Audit: - Alarm is reset manually by IDIN.
6/24/2019 16:19:00 5.2 5.0 29.1 28.4 - - 80 0 -
6/24/2019 16:20:00 4.6 5.0 29.1 28.4 - - 80 0 -
6/24/2019 16:21:00 5.2 5.0 29.0 28.4 - - 80 0 -

-------------------------------------------
Approved by Date Page: 3 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/24/2019 16:22:00 4.8 5.0 29.0 28.4 - - 80 0 -
6/24/2019 16:23:00 5.2 5.0 29.1 28.4 - - 80 0 -
6/24/2019 16:24:00 4.8 5.0 29.0 28.3 - - 80 0 -
6/24/2019 16:25:00 5.1 5.0 29.0 28.3 - - 80 0 -
6/24/2019 16:26:00 4.8 5.0 29.0 28.3 - - 80 0 -
6/24/2019 16:27:00 5.1 5.0 29.0 28.3 - - 80 0 -
6/24/2019 16:28:00 4.8 5.0 29.0 28.3 - - 80 0 -
6/24/2019 16:29:00 5.1 5.0 29.0 28.3 - - 80 0 -
6/24/2019 16:30:00 4.8 5.0 29.0 28.3 - - 80 0 -
6/24/2019 16:31:00 5.2 5.0 29.0 28.3 - - 80 0 -
6/24/2019 16:32:00 4.8 5.0 28.9 28.2 - - 80 0 -
6/24/2019 16:33:00 5.1 5.0 28.9 28.2 - - 80 0 -
6/24/2019 16:34:00 4.6 5.0 28.9 28.2 - - 80 0 -
6/24/2019 16:35:00 5.2 5.0 28.9 28.2 - - 80 0 -
6/24/2019 16:36:00 4.8 5.0 28.9 28.2 - - 80 0 -
6/24/2019 16:36:08 Audit: - Alarm is reset manually by IDIN.
6/24/2019 16:36:10 Audit: - Emergency stop relay is reset manually by IDIN.
6/24/2019 16:37:00 5.2 5.0 28.9 28.2 - - 80 0 -
6/24/2019 16:38:00 4.8 5.0 28.9 28.2 - - 80 0 -
6/24/2019 16:39:00 5.1 5.0 28.9 28.1 - - 80 0 -
6/24/2019 16:39:52 Audit: - Alarm is reset manually by IDIN.
6/24/2019 16:40:00 4.8 5.0 28.8 28.1 - - 80 0 -
6/24/2019 16:40:14 Alarm: CLOSE - Compressor 2 failure.
6/24/2019 16:40:16 Alarm: CLOSE - Compressor 1 failure.
6/24/2019 16:40:36 Audit: - A_COM1FAIL ALARM is acknowledged by IDIN.
Audit: - A_COM2FAIL ALARM is acknowledged by IDIN.
6/24/2019 16:40:37 Audit: - Alarm is reset manually by IDIN.

-------------------------------------------
Approved by Date Page: 4 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/24/2019 16:41:00 5.3 5.0 28.9 28.1 - - 80 0 -
6/24/2019 16:41:05 Audit: - Alarm is reset manually by IDIN.
6/24/2019 16:41:07 Audit: - Alarm is reset manually by IDIN.
6/24/2019 16:41:11 Audit: - Alarm is reset manually by IDIN.
6/24/2019 16:41:27 Audit: - Alarm is reset manually by IDIN.
6/24/2019 16:41:31 Audit: - Alarm is reset manually by IDIN.
6/24/2019 16:41:37 Audit: - Alarm is reset manually by IDIN.
6/24/2019 16:41:42 Audit: - Alarm is reset manually by IDIN.
6/24/2019 16:41:47 Audit: - Alarm is reset manually by IDIN.
6/24/2019 16:42:00 5.4 5.0 28.8 28.1 - - 80 0 -
6/24/2019 16:42:07 Audit: - Alarm is reset manually by IDIN.
6/24/2019 16:42:30 Alarm: CLOSE - Compressor 1 failure.
6/24/2019 16:42:36 Audit: - A_COM1FAIL ALARM is acknowledged by IDIN.
6/24/2019 16:43:00 4.9 5.0 28.8 28.1 - - 80 0 -
6/24/2019 16:43:18 Alarm: CLOSE - Compressor 2 failure.
6/24/2019 16:43:28 Alarm: CLOSE - Compressor 1 failure.
6/24/2019 16:43:41 Audit: - A_COM1FAIL ALARM is acknowledged by IDIN.
Audit: - A_COM2FAIL ALARM is acknowledged by IDIN.
6/24/2019 16:43:44 Audit: - Alarm is reset manually by IDIN.
6/24/2019 16:44:00 5.4 5.0 28.8 28.1 - - 80 0 -
6/24/2019 16:44:43 Audit: - Alarm is reset manually by IDIN.
6/24/2019 16:45:00 5.1 5.0 28.8 28.1 - - 80 0 -
6/24/2019 16:45:19 Alarm: CLOSE - Compressor 1 failure.
6/24/2019 16:45:26 Audit: - A_COM1FAIL ALARM is acknowledged by IDIN.
6/24/2019 16:46:00 5.5 5.0 28.8 28.1 - - 80 0 -
6/24/2019 16:46:40 Audit: - Alarm is reset manually by IDIN.
6/24/2019 16:46:56 Alarm: CLOSE - Compressor 2 failure.

-------------------------------------------
Approved by Date Page: 5 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/24/2019 16:47:00 5.5 5.0 28.7 28.0 - - 80 0 -
6/24/2019 16:47:01 Audit: - A_COM2FAIL ALARM is acknowledged by IDIN.
6/24/2019 16:48:00 5.7 5.0 28.7 28.0 - - 80 0 -
6/24/2019 16:48:14 Alarm: CLOSE - Compressor 2 failure.
6/24/2019 16:48:29 Audit: - A_COM2FAIL ALARM is acknowledged by IDIN.
6/24/2019 16:48:32 Audit: - Alarm is reset manually by IDIN.
6/24/2019 16:49:00 5.7 5.0 28.7 28.1 - - 80 0 -
6/24/2019 16:50:00 5.6 5.0 28.7 28.1 - - 80 0 -
6/24/2019 16:50:04 Alarm: CLOSE - Compressor 1 failure.
6/24/2019 16:50:15 Audit: - A_COM1FAIL ALARM is acknowledged by IDIN.
6/24/2019 16:50:18 Audit: - Alarm is reset manually by IDIN.
6/24/2019 16:50:22 Audit: - Alarm is reset manually by IDIN.
6/24/2019 16:51:00 5.7 5.0 28.7 28.1 - - 80 0 -
6/24/2019 16:52:00 5.6 5.0 28.7 28.1 - - 80 0 -
6/24/2019 16:52:36 Audit: - Alarm is reset manually by IDIN.
6/24/2019 16:52:45 Alarm: CLOSE - Compressor 2 failure.
6/24/2019 16:52:47 Alarm: CLOSE - Compressor 1 failure.
6/24/2019 16:52:52 Audit: - A_COM1FAIL ALARM is acknowledged by IDIN.
Audit: - A_COM2FAIL ALARM is acknowledged by IDIN.
6/24/2019 16:52:55 Audit: - Alarm is reset manually by IDIN.
6/24/2019 16:53:00 5.6 5.0 28.7 28.1 - - 80 0 -
6/24/2019 16:53:06 Audit: - Alarm is reset manually by IDIN.
6/24/2019 16:53:29 Audit: - Alarm is reset manually by IDIN.
6/24/2019 16:53:56 Audit: - Alarm is reset manually by IDIN.
6/24/2019 16:53:59 Audit: - Alarm is reset manually by IDIN.
6/24/2019 16:54:00 5.8 5.0 28.7 28.1 - - 80 0 -
6/24/2019 16:54:01 Audit: - Emergency stop relay is reset manually by IDIN.

-------------------------------------------
Approved by Date Page: 6 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/24/2019 16:55:00 5.9 5.0 28.7 28.1 - - 80 0 -
6/24/2019 16:55:17 Alarm: CLOSE - Compressor 1 failure.
6/24/2019 16:55:31 Audit: - A_COM1FAIL ALARM is acknowledged by IDIN.
6/24/2019 16:55:33 Audit: - Alarm is reset manually by IDIN.
6/24/2019 16:55:43 Audit: - Alarm is reset manually by IDIN.
6/24/2019 16:55:47 Audit: - Alarm is reset manually by IDIN.
6/24/2019 16:56:00 6.0 5.0 28.7 28.1 - - 80 0 -
6/24/2019 16:56:19 Audit: - Alarm is reset manually by IDIN.
6/24/2019 16:56:24 Audit: - Alarm is reset manually by IDIN.
6/24/2019 16:57:00 6.0 5.0 28.6 28.0 - - 80 0 -
6/24/2019 16:58:00 6.1 5.0 28.6 28.0 - - 80 0 -
6/24/2019 16:59:00 5.7 5.0 28.6 28.0 - - 80 0 -
6/24/2019 17:00:00 5.3 5.0 28.6 28.0 - - 80 0 -
6/24/2019 17:00:47 Alarm: CLOSE - Compressor 1 failure.
6/24/2019 17:00:55 Alarm: CLOSE - Compressor 1 failure.
6/24/2019 17:01:00 5.3 5.0 28.6 28.0 - - 80 0 -
6/24/2019 17:02:00 5.0 5.0 28.6 27.9 - - 80 0 -
6/24/2019 17:03:00 4.8 5.0 28.6 27.9 - - 80 0 -
6/24/2019 17:04:00 4.9 5.0 28.5 27.9 - - 80 0 -
6/24/2019 17:05:00 4.9 5.0 28.5 27.9 - - 80 0 -
6/24/2019 17:06:00 4.8 5.0 28.5 27.9 - - 80 0 -
6/24/2019 17:07:00 4.9 5.0 28.4 27.9 - - 80 0 292
6/24/2019 17:08:00 5.0 5.0 28.5 27.8 - - 80 0 18
6/24/2019 17:09:00 5.0 5.0 28.4 27.8 - - 80 0 12
6/24/2019 17:10:00 5.1 5.0 28.4 27.7 - - 80 0 9
6/24/2019 17:11:00 5.1 5.0 28.4 27.8 - - 80 0 8
6/24/2019 17:12:00 5.2 5.0 28.4 27.7 - - 80 0 7

-------------------------------------------
Approved by Date Page: 7 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/24/2019 17:13:00 5.3 5.0 28.4 27.7 - - 80 0 6
6/24/2019 17:14:00 5.2 5.0 28.3 27.7 - - 80 0 6
6/24/2019 17:15:00 5.3 5.0 28.3 27.7 - - 80 0 5
6/24/2019 17:16:00 5.2 5.0 28.3 27.7 - - 80 0 5
6/24/2019 17:17:00 5.2 5.0 28.3 27.7 - - 80 0 5
6/24/2019 17:18:00 5.1 5.0 28.3 27.6 - - 80 0 5
6/24/2019 17:19:00 5.2 5.0 28.3 27.6 - - 80 0 4
6/24/2019 17:20:00 5.1 5.0 28.2 27.6 - - 80 0 4
6/24/2019 17:21:00 5.2 5.0 28.2 27.6 - - 80 0 4
6/24/2019 17:22:00 5.1 5.0 28.2 27.6 - - 80 0 4
6/24/2019 17:23:00 5.2 5.0 28.2 27.6 - - 80 0 4
6/24/2019 17:24:00 5.1 5.0 28.2 27.5 - - 80 0 4
6/24/2019 17:25:00 5.2 5.0 28.2 27.6 - - 80 0 4
6/24/2019 17:26:00 5.1 5.0 28.2 27.5 - - 80 0 4
6/24/2019 17:27:00 5.2 5.0 28.2 27.5 - - 80 0 3
6/24/2019 17:28:00 5.1 5.0 28.1 27.5 - - 80 0 3
6/24/2019 17:28:53 Audit: - A_COM1FAIL ALARM is acknowledged by IDIN.
6/24/2019 17:29:00 5.2 5.0 28.1 27.5 - - 80 0 3
6/24/2019 17:30:00 5.2 5.0 28.1 27.5 - - 80 0 3
6/24/2019 17:31:00 5.2 5.0 28.1 27.5 - - 80 0 3
6/24/2019 17:32:00 5.1 5.0 28.1 27.4 - - 80 0 3
6/24/2019 17:33:00 5.0 5.0 28.1 27.4 - - 80 0 3
6/24/2019 17:34:00 5.1 5.0 28.1 27.4 - - 80 0 3
6/24/2019 17:35:00 5.1 5.0 28.0 27.4 - - 80 0 3
6/24/2019 17:36:00 5.1 5.0 28.0 27.4 - - 80 0 3
6/24/2019 17:37:00 5.1 5.0 28.0 27.4 - - 80 0 3
6/24/2019 17:38:00 5.1 5.0 28.0 27.4 - - 80 0 3

-------------------------------------------
Approved by Date Page: 8 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/24/2019 17:39:00 5.1 5.0 28.0 27.4 - - 80 0 3
6/24/2019 17:40:00 5.2 5.0 28.0 27.3 - - 80 0 3
6/24/2019 17:41:00 5.1 5.0 28.0 27.4 - - 80 0 3
6/24/2019 17:42:00 5.1 5.0 27.9 27.3 - - 80 0 3
6/24/2019 17:43:00 5.0 5.0 27.9 27.3 - - 80 0 3
6/24/2019 17:44:00 5.1 5.0 27.9 27.3 - - 80 0 3
6/24/2019 17:45:00 5.1 5.0 27.9 27.3 - - 80 0 3
6/24/2019 17:46:00 5.2 5.0 27.9 27.3 - - 80 0 3
6/24/2019 17:47:00 4.9 5.0 27.9 27.3 - - 80 0 3
6/24/2019 17:48:00 5.2 5.0 27.9 27.3 - - 80 0 3
6/24/2019 17:49:00 4.8 5.0 27.9 27.2 - - 80 0 3
6/24/2019 17:50:00 5.1 5.0 27.9 27.2 - - 80 0 3
6/24/2019 17:51:00 5.0 5.0 27.9 27.2 - - 80 0 3
6/24/2019 17:52:00 5.2 5.0 27.8 27.2 - - 80 0 3
6/24/2019 17:53:00 4.9 5.0 27.8 27.2 - - 80 0 3
6/24/2019 17:54:00 5.2 5.0 27.8 27.2 - - 80 0 3
6/24/2019 17:55:00 4.9 5.0 27.8 27.1 - - 80 0 3
6/24/2019 17:56:00 5.2 5.0 27.8 27.1 - - 80 0 3
6/24/2019 17:57:00 5.0 5.0 27.8 27.1 - - 80 0 3
6/24/2019 17:58:00 5.2 5.0 27.7 27.1 - - 80 0 3
6/24/2019 17:59:00 4.8 5.0 27.7 27.1 - - 80 0 3
6/24/2019 18:00:00 5.2 5.0 27.7 27.1 - - 80 0 3
6/24/2019 18:01:00 4.9 5.0 27.7 27.1 - - 80 0 3
6/24/2019 18:02:00 5.2 5.0 27.7 27.1 - - 80 0 3
6/24/2019 18:03:00 4.9 5.0 27.7 27.1 - - 80 0 2
6/24/2019 18:04:00 5.2 5.0 27.7 27.0 - - 80 0 2
6/24/2019 18:05:00 5.1 5.0 27.6 27.0 - - 80 0 2

-------------------------------------------
Approved by Date Page: 9 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/24/2019 18:06:00 5.2 5.0 27.6 27.0 - - 80 0 2
6/24/2019 18:07:00 5.0 5.0 27.6 27.0 - - 80 0 2
6/24/2019 18:08:00 5.2 5.0 27.6 27.0 - - 80 0 2
6/24/2019 18:09:00 5.1 5.0 27.6 27.0 - - 80 0 2
6/24/2019 18:10:00 5.2 5.0 27.6 26.9 - - 80 0 2
6/24/2019 18:11:00 5.1 5.0 27.6 27.0 - - 80 0 2
6/24/2019 18:12:00 5.2 5.0 27.6 26.9 - - 80 0 2
6/24/2019 18:13:00 5.1 5.0 27.5 26.9 - - 80 0 2
6/24/2019 18:14:00 5.2 5.0 27.6 26.9 - - 80 0 2
6/24/2019 18:15:00 5.0 5.0 27.5 26.9 - - 80 0 2
6/24/2019 18:16:00 5.2 5.0 27.5 26.9 - - 80 0 2
6/24/2019 18:17:00 5.0 5.0 27.5 26.9 - - 80 0 2
6/24/2019 18:18:00 5.2 5.0 27.5 26.9 - - 80 0 2
6/24/2019 18:19:00 5.1 5.0 27.5 26.8 - - 80 0 2
6/24/2019 18:20:00 5.2 5.0 27.5 26.8 - - 80 0 2
6/24/2019 18:21:00 5.1 5.0 27.5 26.8 - - 80 0 2
6/24/2019 18:22:00 5.2 5.0 27.4 26.8 - - 80 0 2
6/24/2019 18:23:00 5.0 5.0 27.5 26.8 - - 80 0 2
6/24/2019 18:24:00 5.1 5.0 27.4 26.8 - - 80 0 2
6/24/2019 18:25:00 5.0 5.0 27.4 26.7 - - 80 0 2
6/24/2019 18:26:00 5.2 5.0 27.4 26.7 - - 80 0 2
6/24/2019 18:27:00 5.1 5.0 27.4 26.8 - - 80 0 2
6/24/2019 18:28:00 5.2 5.0 27.4 26.7 - - 80 0 2
6/24/2019 18:29:00 5.1 5.0 27.4 26.7 - - 80 0 2
6/24/2019 18:30:00 5.2 5.0 27.4 26.7 - - 80 0 2
6/24/2019 18:31:00 5.1 5.0 27.3 26.7 - - 80 0 2
6/24/2019 18:32:00 5.2 5.0 27.3 26.7 - - 80 0 2

-------------------------------------------
Approved by Date Page: 10 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/24/2019 18:33:00 5.1 5.0 27.3 26.7 - - 80 0 2
6/24/2019 18:34:00 5.2 5.0 27.3 26.6 - - 80 0 2
6/24/2019 18:35:00 5.1 5.0 27.3 26.6 - - 80 0 2
6/24/2019 18:36:00 5.1 5.0 27.3 26.6 - - 80 0 2
6/24/2019 18:37:00 5.1 5.0 27.3 26.6 - - 80 0 2
6/24/2019 18:38:00 5.0 5.0 27.3 26.6 - - 80 0 2
6/24/2019 18:39:00 5.1 5.0 27.3 26.6 - - 80 0 2
6/24/2019 18:40:00 5.1 5.0 27.2 26.6 - - 80 0 2
6/24/2019 18:41:00 5.1 5.0 27.3 26.6 - - 80 0 2
6/24/2019 18:42:00 5.1 5.0 27.2 26.5 - - 80 0 2
6/24/2019 18:43:00 5.1 5.0 27.2 26.6 - - 80 0 2
6/24/2019 18:44:00 5.1 5.0 27.2 26.6 - - 80 0 2
6/24/2019 18:45:00 5.1 5.0 27.2 26.5 - - 80 0 2
6/24/2019 18:46:00 4.9 5.0 27.1 26.5 - - 80 0 2
6/24/2019 18:47:00 5.1 5.0 27.1 26.5 - - 80 0 2
6/24/2019 18:48:00 5.1 5.0 27.1 26.5 - - 80 0 2
6/24/2019 18:49:00 5.1 5.0 27.1 26.5 - - 80 0 2
6/24/2019 18:50:00 5.1 5.0 27.1 26.5 - - 80 0 2
6/24/2019 18:51:00 5.1 5.0 27.1 26.4 - - 80 0 2
6/24/2019 18:52:00 5.1 5.0 27.1 26.4 - - 80 0 2
6/24/2019 18:53:00 5.1 5.0 27.1 26.4 - - 80 0 2
6/24/2019 18:54:00 5.1 5.0 27.1 26.4 - - 80 0 2
6/24/2019 18:55:00 5.1 5.0 27.1 26.4 - - 80 0 2
6/24/2019 18:56:00 5.0 5.0 27.1 26.4 - - 80 0 2
6/24/2019 18:57:00 5.1 5.0 27.1 26.4 - - 80 0 2
6/24/2019 18:58:00 5.0 5.0 27.1 26.4 - - 80 0 2
6/24/2019 18:59:00 5.1 5.0 27.0 26.3 - - 80 0 2

-------------------------------------------
Approved by Date Page: 11 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/24/2019 19:00:00 4.9 5.0 27.0 26.3 - - 80 0 2
6/24/2019 19:01:00 5.2 5.0 27.0 26.3 - - 80 0 2
6/24/2019 19:02:00 5.0 5.0 27.0 26.3 - - 80 0 2
6/24/2019 19:03:00 5.1 5.0 26.9 26.3 - - 80 0 2
6/24/2019 19:04:00 5.0 5.0 26.9 26.3 - - 80 0 2
6/24/2019 19:05:00 5.1 5.0 27.0 26.3 - - 80 0 2
6/24/2019 19:06:00 5.0 5.0 26.9 26.3 - - 80 0 2
6/24/2019 19:07:00 5.1 5.0 26.9 26.3 - - 80 0 2
6/24/2019 19:08:00 5.0 5.0 26.9 26.3 - - 80 0 2
6/24/2019 19:09:00 5.1 5.0 26.9 26.2 - - 80 0 2
6/24/2019 19:10:00 4.9 5.0 26.9 26.2 - - 80 0 2
6/24/2019 19:11:00 5.1 5.0 26.9 26.2 - - 80 0 2
6/24/2019 19:12:00 5.0 5.0 26.9 26.2 - - 80 0 2
6/24/2019 19:13:00 5.2 5.0 26.8 26.1 - - 80 0 2
6/24/2019 19:14:00 5.0 5.0 26.8 26.1 - - 80 0 2
6/24/2019 19:15:00 5.2 5.0 26.8 26.1 - - 80 0 2
6/24/2019 19:16:00 5.0 5.0 26.8 26.1 - - 80 0 2
6/24/2019 19:17:00 5.1 5.0 26.8 26.1 - - 80 0 2
6/24/2019 19:18:00 5.2 5.0 26.8 26.1 - - 80 0 2
6/24/2019 19:19:00 5.2 5.0 26.8 26.1 - - 80 0 2
6/24/2019 19:20:00 5.2 5.0 26.8 26.1 - - 80 0 2
6/24/2019 19:21:00 5.2 5.0 26.8 26.1 - - 80 0 2
6/24/2019 19:22:00 5.1 5.0 26.7 26.0 - - 80 0 2
6/24/2019 19:23:00 5.1 5.0 26.8 26.1 - - 80 0 2
6/24/2019 19:24:00 5.0 5.0 26.7 26.0 - - 80 0 2
6/24/2019 19:25:00 5.1 5.0 26.7 26.0 - - 80 0 2
6/24/2019 19:26:00 5.0 5.0 26.7 26.0 - - 80 0 2

-------------------------------------------
Approved by Date Page: 12 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/24/2019 19:27:00 5.1 5.0 26.7 26.0 - - 80 0 2
6/24/2019 19:28:00 5.1 5.0 26.7 26.0 - - 80 0 2
6/24/2019 19:29:00 5.1 5.0 26.7 26.0 - - 80 0 2
6/24/2019 19:30:00 5.2 5.0 26.7 26.0 - - 80 0 2
6/24/2019 19:31:00 5.2 5.0 26.7 26.0 - - 80 0 2
6/24/2019 19:32:00 5.1 5.0 26.6 25.9 - - 80 0 2
6/24/2019 19:33:00 5.2 5.0 26.7 26.0 - - 80 0 2
6/24/2019 19:34:00 5.1 5.0 26.6 25.9 - - 80 0 2
6/24/2019 19:35:00 5.2 5.0 26.6 25.9 - - 80 0 2
6/24/2019 19:36:00 5.1 5.0 26.6 25.9 - - 80 0 2
6/24/2019 19:37:00 5.2 5.0 26.6 25.9 - - 80 0 2
6/24/2019 19:38:00 5.1 5.0 26.6 25.9 - - 80 0 2
6/24/2019 19:39:00 5.2 5.0 26.6 25.8 - - 80 0 2
6/24/2019 19:40:00 5.1 5.0 26.6 25.8 - - 80 0 2
6/24/2019 19:41:00 5.2 5.0 26.5 25.8 - - 80 0 2
6/24/2019 19:42:00 5.1 5.0 26.5 25.8 - - 80 0 2
6/24/2019 19:43:00 5.2 5.0 26.5 25.8 - - 80 0 2
6/24/2019 19:44:00 5.1 5.0 26.6 25.8 - - 80 0 2
6/24/2019 19:45:00 5.2 5.0 26.5 25.8 - - 80 0 2
6/24/2019 19:46:00 5.1 5.0 26.5 25.8 - - 80 0 2
6/24/2019 19:47:00 5.2 5.0 26.5 25.7 - - 80 0 2
6/24/2019 19:48:00 5.2 5.0 26.5 25.7 - - 80 0 2
6/24/2019 19:49:00 5.2 5.0 26.5 25.7 - - 80 0 2
6/24/2019 19:50:00 5.1 5.0 26.4 25.7 - - 80 0 2
6/24/2019 19:51:00 5.1 5.0 26.5 25.7 - - 80 0 2
6/24/2019 19:52:00 5.1 5.0 26.4 25.7 - - 80 0 2
6/24/2019 19:53:00 5.1 5.0 26.4 25.7 - - 80 0 2

-------------------------------------------
Approved by Date Page: 13 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/24/2019 19:54:00 5.1 5.0 26.4 25.7 - - 80 0 2
6/24/2019 19:55:00 5.1 5.0 26.4 25.7 - - 80 0 2
6/24/2019 19:56:00 5.1 5.0 26.4 25.7 - - 80 0 2
6/24/2019 19:57:00 5.1 5.0 26.4 25.7 - - 80 0 2
6/24/2019 19:58:00 5.2 5.0 26.3 25.7 - - 80 0 2
6/24/2019 19:59:00 5.1 5.0 26.3 25.7 - - 80 0 2
6/24/2019 20:00:00 5.1 5.0 26.3 25.6 - - 80 0 2
6/24/2019 20:01:00 5.1 5.0 26.3 25.6 - - 80 0 2
6/24/2019 20:02:00 5.1 5.0 26.3 25.6 - - 80 0 2
6/24/2019 20:03:00 5.1 5.0 26.3 25.6 - - 80 0 2
6/24/2019 20:04:00 5.1 5.0 26.3 25.6 - - 80 0 2
6/24/2019 20:05:00 5.0 5.0 26.3 25.5 - - 80 0 2
6/24/2019 20:06:00 5.2 5.0 26.3 25.5 - - 80 0 2
6/24/2019 20:07:00 5.1 5.0 26.3 25.5 - - 80 0 2
6/24/2019 20:08:00 5.2 5.0 26.3 25.5 - - 80 0 2
6/24/2019 20:09:00 4.9 5.0 26.2 25.5 - - 80 0 2
6/24/2019 20:10:00 5.2 5.0 26.2 25.5 - - 80 0 2
6/24/2019 20:11:00 5.1 5.0 26.2 25.5 - - 80 0 2
6/24/2019 20:12:00 5.2 5.0 26.2 25.5 - - 80 0 2
6/24/2019 20:13:00 4.8 5.0 26.2 25.5 - - 80 0 2
6/24/2019 20:14:00 5.1 5.0 26.2 25.5 - - 80 0 2
6/24/2019 20:15:00 5.0 5.0 26.1 25.4 - - 80 0 2
6/24/2019 20:16:00 5.2 5.0 26.2 25.5 - - 80 0 2
6/24/2019 20:17:00 5.1 5.0 26.1 25.5 - - 80 0 2
6/24/2019 20:18:00 5.3 5.0 26.1 25.4 - - 80 0 2
6/24/2019 20:19:00 4.8 5.0 26.1 25.4 - - 80 0 2
6/24/2019 20:20:00 5.2 5.0 26.1 25.4 - - 80 0 2

-------------------------------------------
Approved by Date Page: 14 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/24/2019 20:21:00 4.8 5.0 26.1 25.4 - - 80 0 2
6/24/2019 20:22:00 5.2 5.0 26.1 25.4 - - 80 0 2
6/24/2019 20:23:00 4.7 5.0 26.1 25.4 - - 80 0 2
6/24/2019 20:24:00 5.1 5.0 26.1 25.3 - - 80 0 2
6/24/2019 20:25:00 4.8 5.0 26.0 25.4 - - 80 0 2
6/24/2019 20:26:00 5.1 5.0 26.0 25.3 - - 80 0 2
6/24/2019 20:27:00 5.0 5.0 26.0 25.3 - - 80 0 2
6/24/2019 20:28:00 5.2 5.0 26.0 25.3 - - 80 0 2
6/24/2019 20:29:00 5.1 5.0 26.0 25.3 - - 80 0 2
6/24/2019 20:30:00 5.2 5.0 26.0 25.3 - - 80 0 2
6/24/2019 20:31:00 4.9 5.0 26.0 25.3 - - 80 0 2
6/24/2019 20:32:00 5.2 5.0 26.0 25.3 - - 80 0 2
6/24/2019 20:33:00 5.0 5.0 26.0 25.2 - - 80 0 2
6/24/2019 20:34:00 5.2 5.0 26.0 25.2 - - 80 0 2
6/24/2019 20:35:00 5.1 5.0 26.0 25.2 - - 80 0 2
6/24/2019 20:36:00 5.2 5.0 25.9 25.2 - - 80 0 2
6/24/2019 20:37:00 5.0 5.0 25.9 25.2 - - 80 0 2
6/24/2019 20:38:00 5.1 5.0 25.9 25.2 - - 80 0 2
6/24/2019 20:39:00 5.1 5.0 25.9 25.2 - - 80 0 2
6/24/2019 20:40:00 5.1 5.0 25.9 25.2 - - 80 0 2
6/24/2019 20:41:00 5.1 5.0 25.9 25.2 - - 80 0 2
6/24/2019 20:42:00 5.2 5.0 25.9 25.2 - - 80 0 2
6/24/2019 20:43:00 5.1 5.0 25.9 25.1 - - 80 0 2
6/24/2019 20:44:00 5.2 5.0 25.8 25.1 - - 80 0 2
6/24/2019 20:45:00 5.1 5.0 25.8 25.1 - - 80 0 2
6/24/2019 20:46:00 5.2 5.0 25.8 25.1 - - 80 0 2
6/24/2019 20:47:00 5.1 5.0 25.8 25.1 - - 80 0 1

-------------------------------------------
Approved by Date Page: 15 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/24/2019 20:48:00 5.2 5.0 25.7 25.1 - - 80 0 1
6/24/2019 20:49:00 5.1 5.0 25.8 25.1 - - 80 0 1
6/24/2019 20:50:00 5.2 5.0 25.8 25.1 - - 80 0 1
6/24/2019 20:51:00 5.1 5.0 25.7 25.1 - - 80 0 1
6/24/2019 20:52:00 5.2 5.0 25.7 25.0 - - 80 0 1
6/24/2019 20:53:00 5.1 5.0 25.7 25.0 - - 80 0 1
6/24/2019 20:54:00 5.2 5.0 25.7 25.0 - - 80 0 1
6/24/2019 20:55:00 5.1 5.0 25.7 25.0 - - 80 0 1
6/24/2019 20:56:00 5.2 5.0 25.7 25.0 - - 80 0 1
6/24/2019 20:57:00 5.2 5.0 25.7 25.0 - - 80 0 1
6/24/2019 20:58:00 5.3 5.0 25.7 25.0 - - 80 0 1
6/24/2019 20:59:00 5.2 5.0 25.7 25.0 - - 80 0 1
6/24/2019 21:00:00 5.3 5.0 25.7 25.0 - - 80 0 1
6/24/2019 21:01:00 5.2 5.0 25.7 24.9 - - 80 0 1
6/24/2019 21:02:00 4.8 5.0 25.7 24.9 - - 80 0 1
6/24/2019 21:03:00 5.1 5.0 25.6 24.9 - - 80 0 1
6/24/2019 21:04:00 5.2 5.0 25.6 24.9 - - 80 0 1
6/24/2019 21:05:00 5.1 5.0 25.6 24.9 - - 80 0 1
6/24/2019 21:06:00 5.2 5.0 25.6 24.9 - - 80 0 1
6/24/2019 21:07:00 5.1 5.0 25.6 24.9 - - 80 0 1
6/24/2019 21:08:00 5.2 5.0 25.6 24.9 - - 80 0 1
6/24/2019 21:09:00 5.2 5.0 25.6 24.9 - - 80 0 1
6/24/2019 21:10:00 5.0 5.0 25.6 24.9 - - 80 0 1
6/24/2019 21:11:00 5.1 5.0 25.5 24.9 - - 80 0 1
6/24/2019 21:12:00 5.1 5.0 25.5 24.8 - - 80 0 1
6/24/2019 21:13:00 5.1 5.0 25.5 24.8 - - 80 0 1
6/24/2019 21:14:00 5.1 5.0 25.5 24.8 - - 80 0 1

-------------------------------------------
Approved by Date Page: 16 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/24/2019 21:15:00 5.1 5.0 25.5 24.8 - - 80 0 1
6/24/2019 21:16:00 5.1 5.0 25.5 24.8 - - 80 0 1
6/24/2019 21:17:00 5.2 5.0 25.5 24.8 - - 80 0 1
6/24/2019 21:18:00 5.0 5.0 25.5 24.8 - - 80 0 1
6/24/2019 21:19:00 5.1 5.0 25.5 24.7 - - 80 0 1
6/24/2019 21:20:00 5.1 5.0 25.5 24.8 - - 80 0 1
6/24/2019 21:21:00 5.2 5.0 25.5 24.7 - - 80 0 1
6/24/2019 21:22:00 5.1 5.0 25.5 24.7 - - 80 0 1
6/24/2019 21:23:00 5.2 5.0 25.5 24.7 - - 80 0 1
6/24/2019 21:24:00 5.1 5.0 25.4 24.7 - - 80 0 1
6/24/2019 21:25:00 5.2 5.0 25.4 24.7 - - 80 0 1
6/24/2019 21:26:00 5.1 5.0 25.4 24.7 - - 80 0 1
6/24/2019 21:27:00 5.3 5.0 25.4 24.7 - - 80 0 1
6/24/2019 21:28:00 4.9 5.0 25.4 24.7 - - 80 0 1
6/24/2019 21:29:00 5.2 5.0 25.3 24.7 - - 80 0 1
6/24/2019 21:30:00 4.8 5.0 25.4 24.7 - - 80 0 1
6/24/2019 21:31:00 5.2 5.0 25.3 24.7 - - 80 0 1
6/24/2019 21:32:00 4.9 5.0 25.3 24.6 - - 80 0 1
6/24/2019 21:33:00 5.2 5.0 25.3 24.6 - - 80 0 1
6/24/2019 21:34:00 4.8 5.0 25.3 24.7 - - 80 0 1
6/24/2019 21:35:00 5.2 5.0 25.3 24.6 - - 80 0 1
6/24/2019 21:36:00 4.9 5.0 25.3 24.6 - - 80 0 1
6/24/2019 21:37:00 5.2 5.0 25.3 24.6 - - 80 0 1
6/24/2019 21:38:00 5.0 5.0 25.3 24.6 - - 80 0 1
6/24/2019 21:39:00 5.2 5.0 25.2 24.6 - - 80 0 1
6/24/2019 21:40:00 4.7 5.0 25.2 24.5 - - 80 0 1
6/24/2019 21:41:00 5.2 5.0 25.2 24.5 - - 80 0 1

-------------------------------------------
Approved by Date Page: 17 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/24/2019 21:42:00 4.8 5.0 25.2 24.5 - - 80 0 1
6/24/2019 21:43:00 5.2 5.0 25.2 24.5 - - 80 0 1
6/24/2019 21:44:00 4.8 5.0 25.2 24.5 - - 80 0 1
6/24/2019 21:45:00 5.2 5.0 25.2 24.5 - - 80 0 1
6/24/2019 21:46:00 4.9 5.0 25.2 24.5 - - 80 0 1
6/24/2019 21:47:00 5.2 5.0 25.2 24.5 - - 80 0 1
6/24/2019 21:48:00 5.1 5.0 25.2 24.5 - - 80 0 1
6/24/2019 21:49:00 5.2 5.0 25.1 24.5 - - 80 0 1
6/24/2019 21:50:00 5.0 5.0 25.1 24.4 - - 80 0 1
6/24/2019 21:51:00 5.2 5.0 25.1 24.4 - - 80 0 1
6/24/2019 21:52:00 5.1 5.0 25.1 24.4 - - 80 0 1
6/24/2019 21:53:00 5.2 5.0 25.1 24.4 - - 80 0 1
6/24/2019 21:54:00 5.1 5.0 25.1 24.4 - - 80 0 1
6/24/2019 21:55:00 5.2 5.0 25.1 24.4 - - 80 0 1
6/24/2019 21:56:00 5.1 5.0 25.1 24.4 - - 80 0 1
6/24/2019 21:57:00 5.2 5.0 25.1 24.4 - - 80 0 1
6/24/2019 21:58:00 5.1 5.0 25.0 24.4 - - 80 0 1
6/24/2019 21:59:00 5.3 5.0 25.0 24.4 - - 80 0 1
6/24/2019 22:00:00 5.1 5.0 25.0 24.3 - - 80 0 1
6/24/2019 22:01:00 5.2 5.0 25.0 24.3 - - 80 0 1
6/24/2019 22:02:00 5.1 5.0 25.0 24.3 - - 80 0 1
6/24/2019 22:03:00 5.2 5.0 25.0 24.3 - - 80 0 1
6/24/2019 22:04:00 5.1 5.0 25.0 24.3 - - 80 0 1
6/24/2019 22:05:00 5.2 5.0 24.9 24.3 - - 80 0 1
6/24/2019 22:06:00 5.1 5.0 24.9 24.3 - - 80 0 1
6/24/2019 22:07:00 5.2 5.0 24.9 24.3 - - 80 0 1
6/24/2019 22:08:00 5.2 5.0 24.9 24.3 - - 80 0 1

-------------------------------------------
Approved by Date Page: 18 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/24/2019 22:09:00 5.2 5.0 24.9 24.2 - - 80 0 1
6/24/2019 22:10:00 5.1 5.0 24.9 24.3 - - 80 0 1
6/24/2019 22:11:00 5.2 5.0 24.9 24.2 - - 80 0 1
6/24/2019 22:12:00 5.1 5.0 24.9 24.2 - - 80 0 1
6/24/2019 22:13:00 5.2 5.0 24.9 24.2 - - 80 0 1
6/24/2019 22:14:00 5.1 5.0 24.9 24.2 - - 80 0 1
6/24/2019 22:15:00 5.2 5.0 24.9 24.2 - - 80 0 1
6/24/2019 22:16:00 5.1 5.0 24.9 24.2 - - 80 0 1
6/24/2019 22:17:00 5.2 5.0 24.9 24.2 - - 80 0 1
6/24/2019 22:18:00 5.1 5.0 24.8 24.1 - - 80 0 1
6/24/2019 22:19:00 5.2 5.0 24.8 24.1 - - 80 0 1
6/24/2019 22:20:00 5.1 5.0 24.8 24.2 - - 80 0 1
6/24/2019 22:21:00 5.2 5.0 24.8 24.1 - - 80 0 1
6/24/2019 22:22:00 5.2 5.0 24.8 24.1 - - 80 0 1
6/24/2019 22:23:00 5.1 5.0 24.8 24.1 - - 80 0 1
6/24/2019 22:24:00 5.1 5.0 24.8 24.1 - - 80 0 1
6/24/2019 22:25:00 5.2 5.0 24.7 24.1 - - 80 0 1
6/24/2019 22:26:00 5.1 5.0 24.7 24.1 - - 80 0 1
6/24/2019 22:27:00 5.2 5.0 24.7 24.1 - - 80 0 1
6/24/2019 22:28:00 5.1 5.0 24.7 24.1 - - 80 0 1
6/24/2019 22:29:00 5.1 5.0 24.7 24.1 - - 80 0 1
6/24/2019 22:30:00 5.1 5.0 24.7 24.1 - - 80 0 1
6/24/2019 22:31:00 5.1 5.0 24.7 24.1 - - 80 0 1
6/24/2019 22:32:00 5.1 5.0 24.7 24.1 - - 80 0 1
6/24/2019 22:33:00 5.1 5.0 24.7 24.0 - - 80 0 1
6/24/2019 22:34:00 5.1 5.0 24.7 24.0 - - 80 0 1
6/24/2019 22:35:00 5.1 5.0 24.7 24.0 - - 80 0 1

-------------------------------------------
Approved by Date Page: 19 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/24/2019 22:36:00 5.1 5.0 24.7 24.0 - - 80 0 1
6/24/2019 22:37:00 5.0 5.0 24.7 24.0 - - 80 0 1
6/24/2019 22:38:00 5.1 5.0 24.6 24.0 - - 80 0 1
6/24/2019 22:39:00 5.1 5.0 24.6 24.0 - - 80 0 1
6/24/2019 22:40:00 5.1 5.0 24.6 23.9 - - 80 0 1
6/24/2019 22:41:00 5.1 5.0 24.6 23.9 - - 80 0 1
6/24/2019 22:42:00 5.1 5.0 24.6 23.9 - - 80 0 1
6/24/2019 22:43:00 5.1 5.0 24.6 23.9 - - 80 0 1
6/24/2019 22:44:00 5.1 5.0 24.6 23.9 - - 80 0 1
6/24/2019 22:45:00 4.9 5.0 24.6 23.9 - - 80 0 1
6/24/2019 22:46:00 5.1 5.0 24.5 23.9 - - 80 0 1
6/24/2019 22:47:00 5.1 5.0 24.6 23.9 - - 80 0 1
6/24/2019 22:48:00 5.2 5.0 24.6 23.9 - - 80 0 1
6/24/2019 22:49:00 5.1 5.0 24.5 23.8 - - 80 0 1
6/24/2019 22:50:00 5.2 5.0 24.5 23.8 - - 80 0 1
6/24/2019 22:51:00 5.1 5.0 24.5 23.8 - - 80 0 1
6/24/2019 22:52:00 5.2 5.0 24.5 23.8 - - 80 0 1
6/24/2019 22:53:00 5.0 5.0 24.5 23.8 - - 80 0 1
6/24/2019 22:54:00 5.2 5.0 24.5 23.8 - - 80 0 1
6/24/2019 22:55:00 5.0 5.0 24.5 23.8 - - 80 0 1
6/24/2019 22:56:00 5.1 5.0 24.5 23.8 - - 80 0 1
6/24/2019 22:57:00 5.0 5.0 24.4 23.8 - - 80 0 1
6/24/2019 22:58:00 5.2 5.0 24.4 23.8 - - 80 0 1
6/24/2019 22:59:00 4.8 5.0 24.4 23.7 - - 80 0 1
6/24/2019 23:00:00 5.1 5.0 24.4 23.7 - - 80 0 1
6/24/2019 23:01:00 4.8 5.0 24.4 23.8 - - 80 0 1
6/24/2019 23:02:00 5.1 5.0 24.4 23.8 - - 80 0 1

-------------------------------------------
Approved by Date Page: 20 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/24/2019 23:03:00 4.9 5.0 24.4 23.7 - - 80 0 1
6/24/2019 23:04:00 5.1 5.0 24.4 23.7 - - 80 0 1
6/24/2019 23:05:00 4.9 5.0 24.4 23.7 - - 80 0 1
6/24/2019 23:06:00 5.2 5.0 24.3 23.7 - - 80 0 1
6/24/2019 23:07:00 4.8 5.0 24.3 23.7 - - 80 0 1
6/24/2019 23:08:00 5.2 5.0 24.3 23.7 - - 80 0 1
6/24/2019 23:09:00 5.0 5.0 24.3 23.7 - - 80 0 1
6/24/2019 23:10:00 5.2 5.0 24.3 23.7 - - 80 0 1
6/24/2019 23:11:00 5.0 5.0 24.3 23.7 - - 80 0 1
6/24/2019 23:12:00 5.2 5.0 24.3 23.7 - - 80 0 1
6/24/2019 23:13:00 5.2 5.0 24.3 23.6 - - 80 0 1
6/24/2019 23:14:00 5.2 5.0 24.3 23.6 - - 80 0 1
6/24/2019 23:15:00 5.3 5.0 24.3 23.6 - - 80 0 1
6/24/2019 23:16:00 5.2 5.0 24.2 23.6 - - 80 0 1
6/24/2019 23:17:00 5.1 5.0 24.3 23.6 - - 80 0 1
6/24/2019 23:18:00 5.2 5.0 24.2 23.6 - - 80 0 1
6/24/2019 23:19:00 5.1 5.0 24.2 23.6 - - 80 0 1
6/24/2019 23:20:00 5.1 5.0 24.2 23.6 - - 80 0 1
6/24/2019 23:21:00 5.1 5.0 24.2 23.5 - - 80 0 1
6/24/2019 23:22:00 5.1 5.0 24.2 23.6 - - 80 0 1
6/24/2019 23:23:00 5.2 5.0 24.1 23.5 - - 80 0 1
6/24/2019 23:24:00 5.1 5.0 24.1 23.5 - - 80 0 1
6/24/2019 23:25:00 5.1 5.0 24.2 23.5 - - 80 0 1
6/24/2019 23:26:00 5.1 5.0 24.1 23.5 - - 80 0 1
6/24/2019 23:27:00 5.1 5.0 24.1 23.5 - - 80 0 1
6/24/2019 23:28:00 5.1 5.0 24.1 23.5 - - 80 0 1
6/24/2019 23:29:00 5.2 5.0 24.1 23.5 - - 80 0 1

-------------------------------------------
Approved by Date Page: 21 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/24/2019 23:30:00 5.2 5.0 24.1 23.5 - - 80 0 1
6/24/2019 23:31:00 5.1 5.0 24.1 23.5 - - 80 0 1
6/24/2019 23:32:00 5.2 5.0 24.1 23.5 - - 80 0 1
6/24/2019 23:33:00 5.2 5.0 24.1 23.5 - - 80 0 1
6/24/2019 23:34:00 5.2 5.0 24.1 23.5 - - 80 0 1
6/24/2019 23:35:00 5.1 5.0 24.1 23.4 - - 80 0 1
6/24/2019 23:36:00 5.1 5.0 24.1 23.4 - - 80 0 1
6/24/2019 23:37:00 5.1 5.0 24.0 23.4 - - 80 0 1
6/24/2019 23:38:00 5.2 5.0 24.0 23.4 - - 80 0 1
6/24/2019 23:39:00 5.1 5.0 24.0 23.4 - - 80 0 1
6/24/2019 23:40:00 5.1 5.0 24.0 23.4 - - 80 0 1
6/24/2019 23:41:00 5.1 5.0 24.0 23.4 - - 80 0 1
6/24/2019 23:42:00 5.1 5.0 24.0 23.4 - - 80 0 1
6/24/2019 23:43:00 5.1 5.0 24.0 23.4 - - 80 0 1
6/24/2019 23:44:00 5.1 5.0 24.0 23.4 - - 80 0 1
6/24/2019 23:45:00 5.1 5.0 24.0 23.4 - - 80 0 1
6/24/2019 23:46:00 5.1 5.0 23.9 23.3 - - 80 0 1
6/24/2019 23:47:00 5.1 5.0 23.9 23.4 - - 80 0 1
6/24/2019 23:48:00 5.1 5.0 23.9 23.3 - - 80 0 1
6/24/2019 23:49:00 5.1 5.0 23.9 23.3 - - 80 0 1
6/24/2019 23:50:00 5.0 5.0 23.9 23.3 - - 80 0 1
6/24/2019 23:51:00 5.1 5.0 23.9 23.3 - - 80 0 1
6/24/2019 23:52:00 5.1 5.0 23.9 23.3 - - 80 0 1
6/24/2019 23:53:00 5.1 5.0 23.8 23.3 - - 80 0 1
6/24/2019 23:54:00 5.0 5.0 23.9 23.3 - - 80 0 1
6/24/2019 23:55:00 5.1 5.0 23.8 23.3 - - 80 0 1
6/24/2019 23:56:00 5.0 5.0 23.9 23.3 - - 80 0 1

-------------------------------------------
Approved by Date Page: 22 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/24/2019 23:57:00 5.1 5.0 23.8 23.3 - - 80 0 1
6/24/2019 23:58:00 5.0 5.0 23.8 23.3 - - 80 0 1
6/24/2019 23:59:00 5.1 5.0 23.8 23.2 - - 80 0 1
6/25/2019 00:00:00 5.0 5.0 23.8 23.2 - - 80 0 1
6/25/2019 00:01:00 5.1 5.0 23.8 23.2 - - 80 0 1
6/25/2019 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.
6/25/2019 00:02:00 5.0 5.0 23.8 23.2 - - 80 0 1
6/25/2019 00:03:00 5.1 5.0 23.8 23.2 - - 80 0 1
6/25/2019 00:04:00 5.0 5.0 23.8 23.2 - - 80 0 1
6/25/2019 00:05:00 5.3 5.0 23.7 23.2 - - 80 0 1
6/25/2019 00:06:00 5.1 5.0 23.7 23.2 - - 80 0 1
6/25/2019 00:07:00 5.2 5.0 23.7 23.2 - - 80 0 1
6/25/2019 00:08:00 4.8 5.0 23.7 23.2 - - 80 0 1
6/25/2019 00:09:00 5.2 5.0 23.7 23.2 - - 80 0 1
6/25/2019 00:10:00 4.8 5.0 23.7 23.1 - - 80 0 1
6/25/2019 00:11:00 5.1 5.0 23.7 23.1 - - 80 0 1
6/25/2019 00:12:00 4.8 5.0 23.7 23.1 - - 80 0 1
6/25/2019 00:13:00 5.1 5.0 23.7 23.1 - - 80 0 1
6/25/2019 00:14:00 5.0 5.0 23.6 23.1 - - 80 0 1
6/25/2019 00:15:00 5.2 5.0 23.6 23.0 - - 80 0 1
6/25/2019 00:16:00 5.0 5.0 23.7 23.1 - - 80 0 1
6/25/2019 00:17:00 5.2 5.0 23.6 23.1 - - 80 0 1
6/25/2019 00:18:00 4.9 5.0 23.6 23.0 - - 80 0 1
6/25/2019 00:19:00 5.2 5.0 23.7 23.1 - - 80 0 1
6/25/2019 00:20:00 4.9 5.0 23.6 23.0 - - 80 0 1
6/25/2019 00:21:00 5.2 5.0 23.6 23.0 - - 80 0 1

-------------------------------------------
Approved by Date Page: 23 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 00:22:00 4.9 5.0 23.6 23.0 - - 80 0 1
6/25/2019 00:23:00 5.2 5.0 23.6 23.0 - - 80 0 1
6/25/2019 00:24:00 4.9 5.0 23.6 23.0 - - 80 0 1
6/25/2019 00:25:00 5.2 5.0 23.5 23.0 - - 80 0 1
6/25/2019 00:26:00 4.9 5.0 23.6 23.0 - - 80 0 1
6/25/2019 00:27:00 5.2 5.0 23.5 23.0 - - 80 0 1
6/25/2019 00:28:00 4.9 5.0 23.6 23.0 - - 80 0 1
6/25/2019 00:29:00 5.2 5.0 23.6 23.0 - - 80 0 1
6/25/2019 00:30:00 5.1 5.0 23.5 23.0 - - 80 0 1
6/25/2019 00:31:00 5.2 5.0 23.5 23.0 - - 80 0 1
6/25/2019 00:32:00 5.1 5.0 23.5 22.9 - - 80 0 1
6/25/2019 00:33:00 5.3 5.0 23.5 22.9 - - 80 0 1
6/25/2019 00:34:00 5.2 5.0 23.5 22.9 - - 80 0 1
6/25/2019 00:35:00 5.3 5.0 23.5 23.0 - - 80 0 1
6/25/2019 00:36:00 5.1 5.0 23.4 22.9 - - 80 0 1
6/25/2019 00:37:00 5.2 5.0 23.4 22.9 - - 80 0 1
6/25/2019 00:38:00 5.1 5.0 23.4 22.9 - - 80 0 1
6/25/2019 00:39:00 5.2 5.0 23.4 22.9 - - 80 0 1
6/25/2019 00:40:00 5.1 5.0 23.4 22.9 - - 80 0 1
6/25/2019 00:41:00 5.2 5.0 23.4 22.9 - - 80 0 1
6/25/2019 00:42:00 5.0 5.0 23.4 22.8 - - 80 0 1
6/25/2019 00:43:00 5.2 5.0 23.4 22.8 - - 80 0 1
6/25/2019 00:44:00 5.1 5.0 23.4 22.8 - - 80 0 1
6/25/2019 00:45:00 5.2 5.0 23.4 22.8 - - 80 0 1
6/25/2019 00:46:00 5.1 5.0 23.4 22.8 - - 80 0 1
6/25/2019 00:47:00 5.2 5.0 23.4 22.8 - - 80 0 1
6/25/2019 00:48:00 5.1 5.0 23.4 22.8 - - 80 0 1

-------------------------------------------
Approved by Date Page: 24 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 00:49:00 5.2 5.0 23.3 22.8 - - 80 0 1
6/25/2019 00:50:00 5.1 5.0 23.3 22.8 - - 80 0 1
6/25/2019 00:51:00 5.2 5.0 23.3 22.8 - - 80 0 1
6/25/2019 00:52:00 5.1 5.0 23.3 22.8 - - 80 0 1
6/25/2019 00:53:00 5.2 5.0 23.3 22.7 - - 80 0 1
6/25/2019 00:54:00 5.1 5.0 23.3 22.8 - - 80 0 1
6/25/2019 00:55:00 5.2 5.0 23.3 22.7 - - 80 0 1
6/25/2019 00:56:00 5.1 5.0 23.3 22.7 - - 80 0 1
6/25/2019 00:57:00 5.2 5.0 23.2 22.7 - - 80 0 1
6/25/2019 00:58:00 5.1 5.0 23.3 22.7 - - 80 0 1
6/25/2019 00:59:00 5.2 5.0 23.3 22.7 - - 80 0 1
6/25/2019 01:00:00 5.1 5.0 23.3 22.7 - - 80 0 1
6/25/2019 01:01:00 5.2 5.0 23.2 22.7 - - 80 0 1
6/25/2019 01:02:00 5.2 5.0 23.2 22.7 - - 80 0 1
6/25/2019 01:03:00 5.2 5.0 23.2 22.6 - - 80 0 1
6/25/2019 01:04:00 5.2 5.0 23.2 22.6 - - 80 0 1
6/25/2019 01:05:00 5.2 5.0 23.2 22.6 - - 80 0 1
6/25/2019 01:06:00 5.2 5.0 23.2 22.6 - - 80 0 1
6/25/2019 01:06:59 Audit: - The freeze drying cycle is advanced to the next step by IDIN.
Event: - Auto freeze drying advanced to next step.
6/25/2019 01:07:00 5.2 5.0 23.2 22.6 - - 80 0 1
Event: - Step advanced to [2] Freezing
6/25/2019 01:08:00 5.1 5.0 23.2 22.6 - - 80 0 1
6/25/2019 01:09:00 5.2 5.0 23.2 22.6 - - 80 0 1
6/25/2019 01:10:00 5.1 5.0 23.1 22.6 - - 80 0 1
6/25/2019 01:11:00 5.1 5.0 23.1 22.6 - - 80 0 1
6/25/2019 01:12:00 5.1 5.0 23.1 22.6 - - 80 0 1

-------------------------------------------
Approved by Date Page: 25 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 01:13:00 5.1 5.0 23.1 22.6 - - 80 0 1
6/25/2019 01:14:00 5.1 5.0 23.1 22.5 - - 80 0 1
6/25/2019 01:15:00 5.1 5.0 23.1 22.5 - - 80 0 1
6/25/2019 01:16:00 5.1 5.0 23.0 22.5 - - 80 0 1
6/25/2019 01:17:00 5.0 5.0 23.1 22.5 - - 80 0 1
6/25/2019 01:18:00 5.1 5.0 23.0 22.5 - - 80 0 1
6/25/2019 01:19:00 5.1 5.0 23.0 22.5 - - 80 0 1
6/25/2019 01:20:00 5.1 5.0 23.0 22.5 - - 80 0 1
6/25/2019 01:21:00 5.1 5.0 23.0 22.5 - - 80 0 1
6/25/2019 01:22:00 5.1 5.0 23.0 22.5 - - 80 0 1
6/25/2019 01:23:00 5.0 5.0 23.0 22.5 - - 80 0 1
6/25/2019 01:24:00 5.1 5.0 23.0 22.5 - - 80 0 1
6/25/2019 01:25:00 5.0 5.0 23.0 22.5 - - 80 0 1
6/25/2019 01:26:00 5.1 5.0 23.0 22.5 - - 80 0 1
6/25/2019 01:27:00 5.1 5.0 23.0 22.5 - - 80 0 1
6/25/2019 01:28:00 5.2 5.0 23.0 22.4 - - 80 0 1
6/25/2019 01:29:00 5.0 5.0 23.0 22.4 - - 80 0 1
6/25/2019 01:30:00 5.1 5.0 23.0 22.4 - - 80 0 1
6/25/2019 01:31:00 4.9 5.0 23.0 22.4 - - 80 0 1
6/25/2019 01:32:00 5.1 5.0 23.0 22.4 - - 80 0 1
6/25/2019 01:33:00 4.9 5.0 22.9 22.4 - - 80 0 1
6/25/2019 01:34:00 5.1 5.0 22.9 22.4 - - 80 0 1
6/25/2019 01:35:00 5.0 5.0 23.0 22.4 - - 80 0 1
6/25/2019 01:36:00 5.1 5.0 22.9 22.4 - - 80 0 1
6/25/2019 01:36:55 Event: - Step advanced to [3] Freezing
6/25/2019 01:37:00 4.9 5.0 22.9 22.4 - - 80 0 1
6/25/2019 01:38:00 5.1 4.5 22.9 22.3 - - 80 0 1

-------------------------------------------
Approved by Date Page: 26 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 01:39:00 4.5 4.0 22.8 22.3 - - 80 0 1
6/25/2019 01:39:30 Alarm: CLOSE - COM1 discharge high pressure.
6/25/2019 01:39:35 Event: - Auto freeze cycle hold mode activated.
6/25/2019 01:39:59 Audit: - A_COM1DISCHP ALARM is acknowledged by IDIN.
6/25/2019 01:40:00 4.3 3.7 22.9 22.3 - - 80 0 1
6/25/2019 01:41:00 4.1 3.7 22.9 22.3 - - 80 0 1
6/25/2019 01:42:00 4.0 3.7 22.8 22.3 - - 80 0 1
6/25/2019 01:43:00 3.8 3.7 22.8 22.3 - - 80 0 1
6/25/2019 01:44:00 3.7 3.7 22.8 22.3 - - 80 0 1
6/25/2019 01:45:00 3.5 3.7 22.8 22.2 - - 80 0 1
6/25/2019 01:46:00 3.5 3.7 22.8 22.2 - - 80 0 1
6/25/2019 01:46:03 Audit: - Alarm is reset manually by IDIN.
6/25/2019 01:46:08 Audit: - Alarm is reset manually by IDIN.
6/25/2019 01:47:00 3.3 3.7 22.8 22.2 - - 80 0 1
6/25/2019 01:48:00 3.2 3.7 22.8 22.2 - - 80 0 1
6/25/2019 01:49:00 3.2 3.7 22.8 22.2 - - 80 0 1
6/25/2019 01:50:00 3.5 3.7 22.8 22.2 - - 80 0 1
6/25/2019 01:51:00 3.7 3.7 22.8 22.2 - - 80 0 1
6/25/2019 01:52:00 3.7 3.7 22.8 22.2 - - 80 0 1
6/25/2019 01:53:00 3.9 3.7 22.8 22.2 - - 80 0 1
6/25/2019 01:53:50 Event: - Auto freeze cycle hold mode exited.
6/25/2019 01:54:00 3.9 3.6 22.7 22.2 - - 80 0 1
6/25/2019 01:55:00 3.8 3.1 22.8 22.2 - - 80 0 1
6/25/2019 01:56:00 3.4 2.6 22.8 22.2 - - 80 0 1
6/25/2019 01:57:00 3.0 2.1 22.7 22.2 - - 80 0 1
6/25/2019 01:58:00 3.1 1.6 22.7 22.2 - - 80 0 1
6/25/2019 01:59:00 2.7 1.1 22.7 22.2 - - 80 0 1

-------------------------------------------
Approved by Date Page: 27 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 01:59:15 Alarm: CLOSE - COM1 discharge high pressure.
6/25/2019 01:59:20 Event: - Auto freeze cycle hold mode activated.
6/25/2019 02:00:00 2.8 1.0 22.7 22.1 - - 80 0 1
6/25/2019 02:01:00 2.2 1.0 22.7 22.1 - - 80 0 1
6/25/2019 02:01:04 Audit: - A_COM1DISCHP ALARM is acknowledged by IDIN.
6/25/2019 02:01:06 Audit: - Alarm is reset manually by IDIN.
6/25/2019 02:02:00 2.4 1.0 22.6 22.1 - - 80 0 1
6/25/2019 02:02:44 Alarm: CLOSE - Heater failure.
6/25/2019 02:03:00 2.2 1.0 22.6 22.1 - - 80 0 1
6/25/2019 02:04:00 2.2 1.0 22.6 22.1 - - 80 0 1
6/25/2019 02:05:00 2.6 1.0 22.6 22.1 - - 80 0 1
6/25/2019 02:06:00 2.1 1.0 22.6 22.1 - - 80 0 1
6/25/2019 02:07:00 1.7 1.0 22.6 22.1 - - 80 0 1
6/25/2019 02:07:35 Event: - Auto freeze cycle hold mode exited.
6/25/2019 02:08:00 1.8 0.8 22.6 22.0 - - 80 0 1
6/25/2019 02:09:00 1.4 0.2 22.6 22.0 - - 80 0 1
6/25/2019 02:10:00 1.2 -0.2 22.6 22.0 - - 80 0 1
6/25/2019 02:11:00 1.0 -0.8 22.6 22.0 - - 80 0 1
6/25/2019 02:12:00 0.6 -1.2 22.5 22.0 - - 80 0 1
6/25/2019 02:13:00 0.2 -1.8 22.5 22.0 - - 80 0 1
6/25/2019 02:14:00 0.3 -2.2 22.5 22.0 - - 80 0 1
6/25/2019 02:15:00 0.0 -2.8 22.5 22.0 - - 80 0 1
6/25/2019 02:15:01 Alarm: CLOSE - COM1 discharge high pressure.
6/25/2019 02:15:05 Event: - Auto freeze cycle hold mode activated.
6/25/2019 02:15:21 Audit: - A_COM1DISCHP ALARM is acknowledged by IDIN.
Audit: - A_HTRFAIL ALARM is acknowledged by IDIN.
6/25/2019 02:16:00 -0.3 -2.8 22.5 21.9 - - 80 0 1

-------------------------------------------
Approved by Date Page: 28 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 02:17:00 0.2 -2.8 22.5 22.0 - - 80 0 1
6/25/2019 02:17:35 Event: - Auto freeze cycle hold mode exited.
6/25/2019 02:18:00 -0.2 -3.0 22.5 21.9 - - 80 0 1
6/25/2019 02:19:00 -0.4 -3.5 22.5 21.9 - - 80 0 1
6/25/2019 02:20:00 -2.3 -4.0 22.4 21.9 - - 80 0 1
6/25/2019 02:21:00 -1.5 -4.5 22.4 21.9 - - 80 0 1
6/25/2019 02:22:00 -1.8 -5.0 22.4 21.9 - - 80 0 1
6/25/2019 02:23:00 -4.0 -5.5 22.4 21.9 - - 80 0 1
6/25/2019 02:24:00 -4.0 -6.0 22.4 21.9 - - 80 0 1
6/25/2019 02:24:42 Alarm: CLOSE - Heater failure.
6/25/2019 02:25:00 -6.5 -6.5 22.4 21.8 - - 80 0 1
6/25/2019 02:25:06 Alarm: CLOSE - Heater failure.
6/25/2019 02:25:27 Alarm: CLOSE - Heater failure.
6/25/2019 02:26:00 -7.9 -7.0 22.4 21.8 - - 80 0 1
6/25/2019 02:27:00 -7.4 -7.5 22.4 21.8 - - 80 0 1
6/25/2019 02:28:00 -7.8 -8.0 22.3 21.8 - - 80 0 1
6/25/2019 02:28:29 Audit: - Alarm is reset manually by IDIN.
6/25/2019 02:28:30 Audit: - A_HTRFAIL ALARM is acknowledged by IDIN.
6/25/2019 02:29:00 -8.5 -8.5 22.3 21.8 - - 80 0 1
6/25/2019 02:30:00 -8.5 -9.0 22.3 21.8 - - 80 0 1
6/25/2019 02:31:00 -9.0 -9.5 22.3 21.8 - - 80 0 1
6/25/2019 02:32:00 -9.6 -10.0 22.2 21.7 - - 80 0 1
6/25/2019 02:33:00 -10.0 -10.5 22.3 21.8 - - 80 0 1
6/25/2019 02:34:00 -10.6 -11.0 22.3 21.7 - - 80 0 1
6/25/2019 02:35:00 -11.1 -11.5 22.2 21.7 - - 80 0 1
6/25/2019 02:36:00 -11.7 -12.0 22.2 21.7 - - 80 0 1
6/25/2019 02:37:00 -12.0 -12.5 22.2 21.7 - - 80 0 1

-------------------------------------------
Approved by Date Page: 29 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 02:38:00 -12.6 -13.0 22.2 21.7 - - 80 0 1
6/25/2019 02:39:00 -13.0 -13.5 22.2 21.7 - - 80 0 1
6/25/2019 02:40:00 -13.5 -14.0 22.2 21.7 - - 80 0 1
6/25/2019 02:41:00 -13.9 -14.5 22.2 21.6 - - 80 0 1
6/25/2019 02:42:00 -14.5 -15.0 22.1 21.6 - - 80 0 1
6/25/2019 02:43:00 -15.0 -15.5 22.1 21.6 - - 80 0 1
6/25/2019 02:44:00 -15.6 -16.0 22.1 21.6 - - 80 0 1
6/25/2019 02:45:00 -16.0 -16.5 22.1 21.6 - - 80 0 1
6/25/2019 02:46:00 -16.5 -17.0 22.1 21.6 - - 80 0 1
6/25/2019 02:47:00 -17.0 -17.5 22.0 21.6 - - 80 0 1
6/25/2019 02:48:00 -17.5 -18.0 22.0 21.5 - - 80 0 1
6/25/2019 02:49:00 -18.1 -18.5 22.0 21.6 - - 80 0 1
6/25/2019 02:50:00 -18.5 -19.0 22.0 21.5 - - 80 0 1
6/25/2019 02:51:00 -19.1 -19.5 22.0 21.5 - - 80 0 1
6/25/2019 02:52:00 -19.6 -20.0 22.0 21.5 - - 80 0 1
6/25/2019 02:53:00 -20.0 -20.5 22.0 21.5 - - 80 0 1
6/25/2019 02:54:00 -20.7 -21.0 21.9 21.4 - - 80 0 1
6/25/2019 02:55:00 -21.1 -21.5 21.9 21.4 - - 80 0 1
6/25/2019 02:56:00 -21.7 -22.0 21.9 21.4 - - 80 0 1
6/25/2019 02:57:00 -22.2 -22.5 21.9 21.4 - - 80 0 1
6/25/2019 02:58:00 -22.7 -23.0 21.9 21.4 - - 80 0 1
6/25/2019 02:59:00 -23.2 -23.5 21.9 21.4 - - 80 0 1
6/25/2019 03:00:00 -23.8 -24.0 21.9 21.4 - - 80 0 1
6/25/2019 03:01:00 -24.3 -24.5 21.9 21.4 - - 80 0 1
6/25/2019 03:02:00 -24.8 -25.0 21.9 21.4 - - 80 0 1
6/25/2019 03:03:00 -25.2 -25.5 21.8 21.4 - - 80 0 1
6/25/2019 03:04:00 -25.7 -26.0 21.8 21.4 - - 80 0 1

-------------------------------------------
Approved by Date Page: 30 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 03:05:00 -25.3 -26.5 21.8 21.4 - - 80 0 1
6/25/2019 03:06:00 -25.9 -27.0 21.8 21.4 - - 80 0 1
6/25/2019 03:07:00 -26.4 -27.5 21.8 21.3 - - 80 0 1
6/25/2019 03:08:00 -26.7 -28.0 21.8 21.3 - - 80 0 1
6/25/2019 03:09:00 -27.1 -28.5 21.8 21.3 - - 80 0 1
6/25/2019 03:10:00 -27.4 -29.0 21.7 21.3 - - 80 0 1
6/25/2019 03:11:00 -27.7 -29.5 21.8 21.3 - - 80 0 1
6/25/2019 03:12:00 -28.0 -30.0 21.7 21.3 - - 80 0 1
6/25/2019 03:13:00 -28.2 -30.5 21.7 21.3 - - 80 0 1
6/25/2019 03:14:00 -28.3 -31.0 21.7 21.2 - - 80 0 1
6/25/2019 03:15:00 -28.6 -31.5 21.7 21.2 - - 80 0 1
6/25/2019 03:16:00 -28.8 -32.0 21.7 21.2 - - 80 0 1
6/25/2019 03:17:00 -29.0 -32.5 21.7 21.2 - - 80 0 1
6/25/2019 03:18:00 -29.2 -33.0 21.7 21.2 - - 80 0 1
6/25/2019 03:18:40 Event: - Auto freeze cycle hold mode activated.
6/25/2019 03:19:00 -29.3 -33.4 21.6 21.1 - - 80 0 1
6/25/2019 03:20:00 -29.5 -33.4 21.6 21.1 - - 80 0 1
6/25/2019 03:21:00 -29.4 -33.4 21.6 21.1 - - 80 0 1
6/25/2019 03:22:00 -29.6 -33.4 21.6 21.1 - - 80 0 1
6/25/2019 03:23:00 -29.7 -33.4 21.6 21.1 - - 80 0 1
6/25/2019 03:24:00 -29.8 -33.4 21.6 21.1 - - 80 0 1
6/25/2019 03:25:00 -29.9 -33.4 21.6 21.1 - - 80 0 1
6/25/2019 03:26:00 -30.0 -33.4 21.6 21.1 - - 80 0 1
6/25/2019 03:27:00 -30.0 -33.4 21.6 21.1 - - 80 0 1
6/25/2019 03:28:00 -30.1 -33.4 21.5 21.0 - - 80 0 1
6/25/2019 03:29:00 -30.2 -33.4 21.5 21.0 - - 80 0 1
6/25/2019 03:30:00 -30.3 -33.4 21.5 21.0 - - 80 0 1

-------------------------------------------
Approved by Date Page: 31 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 03:31:00 -30.4 -33.4 21.5 21.0 - - 80 0 1
6/25/2019 03:32:00 -30.6 -33.4 21.5 21.0 - - 80 0 1
6/25/2019 03:33:00 -30.7 -33.4 21.5 21.0 - - 80 0 1
6/25/2019 03:34:00 -30.9 -33.4 21.4 21.0 - - 80 0 1
6/25/2019 03:35:00 -31.1 -33.4 21.4 21.0 - - 80 0 1
6/25/2019 03:36:00 -31.2 -33.4 21.4 21.0 - - 80 0 1
6/25/2019 03:37:00 -31.4 -33.4 21.4 21.0 - - 80 0 1
6/25/2019 03:38:00 -31.5 -33.4 21.4 20.9 - - 80 0 1
6/25/2019 03:39:00 -31.7 -33.4 21.4 20.9 - - 80 0 1
6/25/2019 03:40:00 -31.9 -33.4 21.4 20.9 - - 80 0 1
6/25/2019 03:41:00 -32.1 -33.4 21.4 20.9 - - 80 0 1
6/25/2019 03:42:00 -32.3 -33.4 21.4 20.9 - - 80 0 1
6/25/2019 03:42:40 Event: - Auto freeze cycle hold mode exited.
6/25/2019 03:43:00 -32.5 -33.5 21.4 20.9 - - 80 0 1
6/25/2019 03:44:00 -32.8 -34.0 21.3 20.8 - - 80 0 1
6/25/2019 03:45:00 -33.0 -34.5 21.3 20.9 - - 80 0 1
6/25/2019 03:46:00 -33.1 -35.0 21.3 20.8 - - 80 0 1
6/25/2019 03:47:00 -33.3 -35.5 21.3 20.8 - - 80 0 1
6/25/2019 03:48:00 -33.6 -36.0 21.3 20.8 - - 80 0 1
6/25/2019 03:49:00 -33.8 -36.5 21.2 20.8 - - 80 0 1
6/25/2019 03:50:00 -34.1 -37.0 21.3 20.8 - - 80 0 1
6/25/2019 03:51:00 -34.3 -37.5 21.2 20.8 - - 80 0 1
6/25/2019 03:52:00 -34.5 -38.0 21.2 20.8 - - 80 0 1
6/25/2019 03:53:00 -34.7 -38.5 21.2 20.8 - - 80 0 1
6/25/2019 03:53:50 Event: - Auto freeze cycle hold mode activated.
6/25/2019 03:54:00 -35.0 -39.0 21.2 20.8 - - 80 0 1
6/25/2019 03:55:00 -35.2 -39.0 21.2 20.7 - - 80 0 1

-------------------------------------------
Approved by Date Page: 32 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 03:56:00 -35.4 -39.0 21.2 20.7 - - 80 0 1
6/25/2019 03:57:00 -35.6 -39.0 21.2 20.7 - - 80 0 1
6/25/2019 03:57:46 Alarm: CLOSE - Heater failure.
6/25/2019 03:58:00 -35.8 -39.0 21.2 20.7 - - 80 0 1
6/25/2019 03:59:00 -36.0 -39.0 21.1 20.7 - - 80 0 1
6/25/2019 04:00:00 -36.4 -39.0 21.1 20.6 - - 80 0 1
6/25/2019 04:01:00 -36.7 -39.0 21.1 20.6 - - 80 0 1
6/25/2019 04:02:00 -36.9 -39.0 21.1 20.6 - - 80 0 1
6/25/2019 04:03:00 -37.1 -39.0 21.1 20.6 - - 80 0 1
6/25/2019 04:04:00 -37.3 -39.0 21.1 20.6 - - 80 0 1
6/25/2019 04:05:00 -37.5 -39.0 21.1 20.6 - - 80 0 1
6/25/2019 04:06:00 -37.8 -39.0 21.0 20.6 - - 80 0 1
6/25/2019 04:07:00 -38.0 -39.0 21.0 20.6 - - 80 0 1
6/25/2019 04:07:15 Event: - Auto freeze cycle hold mode exited.
6/25/2019 04:08:00 -38.2 -39.4 21.1 20.6 - - 80 0 1
6/25/2019 04:09:00 -38.3 -39.8 21.0 20.6 - - 80 0 1
6/25/2019 04:10:00 -38.5 -40.4 21.0 20.6 - - 80 0 1
6/25/2019 04:11:00 -38.7 -40.8 21.0 20.6 - - 80 0 1
6/25/2019 04:12:00 -38.8 -41.4 21.0 20.6 - - 80 0 1
6/25/2019 04:13:00 -39.0 -41.8 20.9 20.5 - - 80 0 1
6/25/2019 04:14:00 -39.2 -42.4 20.9 20.5 - - 80 0 1
6/25/2019 04:15:00 -39.3 -42.8 20.9 20.5 - - 80 0 1
6/25/2019 04:16:00 -39.5 -43.4 20.9 20.5 - - 80 0 1
6/25/2019 04:16:20 Event: - Auto freeze cycle hold mode activated.
6/25/2019 04:17:00 -39.6 -43.6 20.9 20.4 - - 80 0 1
6/25/2019 04:18:00 -39.7 -43.6 20.9 20.4 - - 80 0 1
6/25/2019 04:19:00 -39.8 -43.6 20.9 20.4 - - 80 0 1

-------------------------------------------
Approved by Date Page: 33 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 04:20:00 -39.9 -43.6 20.9 20.4 - - 80 0 1
6/25/2019 04:21:00 -40.1 -43.6 20.9 20.4 - - 80 0 1
6/25/2019 04:22:00 -40.2 -43.6 20.8 20.4 - - 80 0 1
6/25/2019 04:23:00 -40.3 -43.6 20.8 20.4 - - 80 0 1
6/25/2019 04:24:00 -40.4 -43.6 20.8 20.4 - - 80 0 1
6/25/2019 04:25:00 -40.5 -43.6 20.8 20.3 - - 80 0 1
6/25/2019 04:26:00 -40.6 -43.6 20.8 20.3 - - 80 0 1
6/25/2019 04:27:00 -40.7 -43.6 20.8 20.4 - - 80 0 1
6/25/2019 04:28:00 -40.9 -43.6 20.8 20.3 - - 80 0 1
6/25/2019 04:29:00 -41.0 -43.6 20.7 20.3 - - 80 0 1
6/25/2019 04:30:00 -41.0 -43.6 20.7 20.3 - - 80 0 1
6/25/2019 04:31:00 -41.1 -43.6 20.7 20.3 - - 80 0 1
6/25/2019 04:32:00 -41.2 -43.6 20.7 20.3 - - 80 0 1
6/25/2019 04:33:00 -41.3 -43.6 20.6 20.3 - - 80 0 1
6/25/2019 04:34:00 -41.4 -43.6 20.7 20.3 - - 80 0 1
6/25/2019 04:35:00 -41.5 -43.6 20.6 20.2 - - 80 0 1
6/25/2019 04:36:00 -41.5 -43.6 20.6 20.2 - - 80 0 1
6/25/2019 04:37:00 -41.6 -43.6 20.6 20.2 - - 80 0 1
6/25/2019 04:38:00 -41.7 -43.6 20.6 20.2 - - 80 0 1
6/25/2019 04:39:00 -41.8 -43.6 20.6 20.2 - - 80 0 1
6/25/2019 04:40:00 -41.9 -43.6 20.6 20.2 - - 80 0 1
6/25/2019 04:41:00 -41.9 -43.6 20.6 20.2 - - 80 0 1
6/25/2019 04:42:00 -42.0 -43.6 20.6 20.1 - - 80 0 1
6/25/2019 04:43:00 -42.1 -43.6 20.6 20.1 - - 80 0 1
6/25/2019 04:44:00 -42.2 -43.6 20.6 20.1 - - 80 0 1
6/25/2019 04:45:00 -42.3 -43.6 20.6 20.1 - - 80 0 1
6/25/2019 04:46:00 -42.3 -43.6 20.5 20.1 - - 80 0 1

-------------------------------------------
Approved by Date Page: 34 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 04:47:00 -42.4 -43.6 20.5 20.1 - - 80 0 1
6/25/2019 04:48:00 -42.5 -43.6 20.5 20.1 - - 80 0 1
6/25/2019 04:49:00 -42.5 -43.6 20.5 20.1 - - 80 0 1
6/25/2019 04:50:00 -42.6 -43.6 20.5 20.1 - - 80 0 1
6/25/2019 04:50:20 Event: - Auto freeze cycle hold mode exited.
6/25/2019 04:51:00 -42.7 -43.9 20.4 20.0 - - 80 0 1
6/25/2019 04:52:00 -42.7 -44.4 20.4 20.0 - - 80 0 1
6/25/2019 04:53:00 -42.8 -44.9 20.4 20.0 - - 80 0 1
6/25/2019 04:53:10 Event: - Auto freeze cycle hold mode activated.
6/25/2019 04:54:00 -42.8 -45.0 20.4 20.0 - - 80 0 1
6/25/2019 04:55:00 -42.9 -45.0 20.4 20.0 - - 80 0 1
6/25/2019 04:56:00 -42.9 -45.0 20.4 20.0 - - 80 0 1
6/25/2019 04:57:00 -43.0 -45.0 20.4 20.0 - - 80 0 1
6/25/2019 04:58:00 -43.0 -45.0 20.3 19.9 - - 80 0 1
6/25/2019 04:59:00 -43.1 -45.0 20.3 19.9 - - 80 0 1
6/25/2019 05:00:00 -43.1 -45.0 20.3 19.9 - - 80 0 1
6/25/2019 05:01:00 -43.2 -45.0 20.3 19.9 - - 80 0 1
6/25/2019 05:02:00 -43.2 -45.0 20.3 19.9 - - 80 0 1
6/25/2019 05:03:00 -43.2 -45.0 20.3 19.9 - - 80 0 1
6/25/2019 05:04:00 -43.3 -45.0 20.3 19.9 - - 80 0 1
6/25/2019 05:05:00 -43.3 -45.0 20.3 19.9 - - 80 0 1
6/25/2019 05:06:00 -43.4 -45.0 20.2 19.9 - - 80 0 1
6/25/2019 05:07:00 -43.4 -45.0 20.2 19.8 - - 80 0 1
6/25/2019 05:08:00 -43.5 -45.0 20.2 19.8 - - 80 0 1
6/25/2019 05:09:00 -43.5 -45.0 20.2 19.8 - - 80 0 1
6/25/2019 05:10:00 -43.5 -45.0 20.2 19.8 - - 80 0 1
6/25/2019 05:11:00 -43.6 -45.0 20.2 19.8 - - 80 0 1

-------------------------------------------
Approved by Date Page: 35 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 05:12:00 -43.6 -45.0 20.2 19.8 - - 80 0 1
6/25/2019 05:13:00 -43.6 -45.0 20.2 19.8 - - 80 0 1
6/25/2019 05:14:00 -43.7 -45.0 20.1 19.8 - - 80 0 1
6/25/2019 05:15:00 -43.7 -45.0 20.2 19.8 - - 80 0 1
6/25/2019 05:16:00 -43.8 -45.0 20.1 19.7 - - 80 0 1
6/25/2019 05:17:00 -43.8 -45.0 20.1 19.8 - - 80 0 1
6/25/2019 05:18:00 -43.8 -45.0 20.1 19.7 - - 80 0 1
6/25/2019 05:19:00 -43.9 -45.0 20.1 19.7 - - 80 0 1
6/25/2019 05:20:00 -44.0 -45.0 20.0 19.7 - - 80 0 1
6/25/2019 05:21:00 -44.0 -45.0 20.1 19.7 - - 80 0 1
6/25/2019 05:21:36 Alarm: CLOSE - Heater failure.
6/25/2019 05:22:00 -44.0 -45.0 20.0 19.7 - - 80 0 1
6/25/2019 05:22:10 Event: - Step advanced to [4] Freezing
6/25/2019 05:22:15 Event: - Auto freeze cycle hold mode exited.
6/25/2019 05:23:00 -44.0 -45.0 20.0 19.7 - - 80 0 1
6/25/2019 05:24:00 -44.1 -45.0 20.0 19.6 - - 80 0 1
6/25/2019 05:25:00 -44.1 -45.0 20.0 19.6 - - 80 0 1
6/25/2019 05:25:24 Alarm: CLOSE - Heater failure.
6/25/2019 05:26:00 -44.2 -45.0 20.0 19.6 - - 80 0 1
6/25/2019 05:27:00 -44.2 -45.0 20.0 19.6 - - 80 0 1
6/25/2019 05:28:00 -44.2 -45.0 19.9 19.6 - - 80 0 1
6/25/2019 05:29:00 -44.2 -45.0 19.9 19.5 - - 80 0 1
6/25/2019 05:30:00 -44.3 -45.0 19.9 19.5 - - 80 0 1
6/25/2019 05:31:00 -44.3 -45.0 19.9 19.5 - - 80 0 1
6/25/2019 05:32:00 -44.3 -45.0 19.9 19.5 - - 80 0 1
6/25/2019 05:33:00 -44.4 -45.0 19.9 19.5 - - 80 0 1
6/25/2019 05:34:00 -44.4 -45.0 19.8 19.5 - - 80 0 1

-------------------------------------------
Approved by Date Page: 36 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 05:35:00 -44.4 -45.0 19.9 19.5 - - 80 0 1
6/25/2019 05:36:00 -44.4 -45.0 19.8 19.5 - - 80 0 1
6/25/2019 05:37:00 -44.5 -45.0 19.8 19.5 - - 80 0 1
6/25/2019 05:38:00 -44.5 -45.0 19.8 19.5 - - 80 0 1
6/25/2019 05:39:00 -44.5 -45.0 19.8 19.4 - - 80 0 1
6/25/2019 05:40:00 -44.5 -45.0 19.8 19.4 - - 80 0 1
6/25/2019 05:41:00 -44.5 -45.0 19.8 19.4 - - 80 0 1
6/25/2019 05:42:00 -44.5 -45.0 19.8 19.4 - - 80 0 1
6/25/2019 05:43:00 -44.4 -45.0 19.8 19.4 - - 80 0 1
6/25/2019 05:44:00 -44.4 -45.0 19.7 19.3 - - 80 0 1
6/25/2019 05:45:00 -44.5 -45.0 19.7 19.4 - - 80 0 1
6/25/2019 05:46:00 -44.4 -45.0 19.7 19.3 - - 80 0 1
6/25/2019 05:47:00 -44.5 -45.0 19.7 19.3 - - 80 0 1
6/25/2019 05:48:00 -44.5 -45.0 19.7 19.3 - - 80 0 1
6/25/2019 05:49:00 -44.5 -45.0 19.6 19.3 - - 80 0 1
6/25/2019 05:50:00 -44.5 -45.0 19.6 19.3 - - 80 0 1
6/25/2019 05:51:00 -44.5 -45.0 19.6 19.3 - - 80 0 1
6/25/2019 05:52:00 -44.6 -45.0 19.6 19.3 - - 80 0 1
6/25/2019 05:53:00 -44.6 -45.0 19.6 19.3 - - 80 0 1
6/25/2019 05:54:00 -44.6 -45.0 19.6 19.2 - - 80 0 1
6/25/2019 05:55:00 -44.6 -45.0 19.5 19.2 - - 80 0 1
6/25/2019 05:56:00 -44.6 -45.0 19.5 19.2 - - 80 0 1
6/25/2019 05:57:00 -44.7 -45.0 19.5 19.2 - - 80 0 1
6/25/2019 05:58:00 -44.7 -45.0 19.5 19.2 - - 80 0 1
6/25/2019 05:59:00 -44.7 -45.0 19.5 19.2 - - 80 0 1
6/25/2019 06:00:00 -44.7 -45.0 19.5 19.2 - - 80 0 1
6/25/2019 06:01:00 -44.7 -45.0 19.5 19.1 - - 80 0 1

-------------------------------------------
Approved by Date Page: 37 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 06:02:00 -44.7 -45.0 19.5 19.2 - - 80 0 1
6/25/2019 06:03:00 -44.7 -45.0 19.5 19.1 - - 80 0 1
6/25/2019 06:04:00 -44.7 -45.0 19.5 19.1 - - 80 0 1
6/25/2019 06:05:00 -44.8 -45.0 19.5 19.1 - - 80 0 1
6/25/2019 06:06:00 -44.8 -45.0 19.5 19.1 - - 80 0 1
6/25/2019 06:07:00 -44.8 -45.0 19.4 19.1 - - 80 0 1
6/25/2019 06:08:00 -44.8 -45.0 19.4 19.1 - - 80 0 1
6/25/2019 06:09:00 -44.8 -45.0 19.4 19.0 - - 80 0 1
6/25/2019 06:10:00 -44.8 -45.0 19.4 19.1 - - 80 0 1
6/25/2019 06:11:00 -44.8 -45.0 19.3 19.0 - - 80 0 1
6/25/2019 06:12:00 -44.9 -45.0 19.3 19.0 - - 80 0 1
6/25/2019 06:13:00 -44.9 -45.0 19.3 19.0 - - 80 0 1
6/25/2019 06:14:00 -44.9 -45.0 19.3 19.0 - - 80 0 1
6/25/2019 06:15:00 -44.9 -45.0 19.3 19.0 - - 80 0 1
6/25/2019 06:16:00 -44.9 -45.0 19.3 19.0 - - 80 0 1
6/25/2019 06:17:00 -44.9 -45.0 19.3 19.0 - - 80 0 1
6/25/2019 06:18:00 -44.9 -45.0 19.3 19.0 - - 80 0 1
6/25/2019 06:19:00 -45.0 -45.0 19.2 18.9 - - 80 0 1
6/25/2019 06:20:00 -45.0 -45.0 19.2 18.9 - - 80 0 1
6/25/2019 06:21:00 -45.0 -45.0 19.2 18.9 - - 80 0 1
6/25/2019 06:22:00 -45.0 -45.0 19.2 18.9 - - 80 0 1
6/25/2019 06:23:00 -45.0 -45.0 19.2 18.9 - - 80 0 1
6/25/2019 06:24:00 -45.0 -45.0 19.2 18.9 - - 80 0 1
6/25/2019 06:25:00 -45.0 -45.0 19.2 18.9 - - 80 0 1
6/25/2019 06:26:00 -45.0 -45.0 19.1 18.8 - - 80 0 1
6/25/2019 06:27:00 -45.0 -45.0 19.2 18.8 - - 80 0 1
6/25/2019 06:28:00 -45.0 -45.0 19.1 18.8 - - 80 0 1

-------------------------------------------
Approved by Date Page: 38 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 06:29:00 -45.0 -45.0 19.1 18.8 - - 80 0 1
6/25/2019 06:30:00 -45.0 -45.0 19.1 18.8 - - 80 0 1
6/25/2019 06:31:00 -45.1 -45.0 19.0 18.7 - - 80 0 1
6/25/2019 06:32:00 -45.0 -45.0 19.0 18.7 - - 80 0 1
6/25/2019 06:33:00 -45.0 -45.0 19.1 18.7 - - 80 0 1
6/25/2019 06:34:00 -45.0 -45.0 19.0 18.7 - - 80 0 1
6/25/2019 06:35:00 -45.0 -45.0 19.0 18.7 - - 80 0 1
6/25/2019 06:36:00 -45.0 -45.0 19.0 18.7 - - 80 0 1
6/25/2019 06:37:00 -45.0 -45.0 19.0 18.7 - - 80 0 1
6/25/2019 06:38:00 -45.0 -45.0 19.0 18.7 - - 80 0 1
6/25/2019 06:39:00 -45.0 -45.0 19.0 18.7 - - 80 0 1
6/25/2019 06:40:00 -45.0 -45.0 18.9 18.6 - - 80 0 1
6/25/2019 06:41:00 -45.0 -45.0 18.9 18.7 - - 80 0 1
6/25/2019 06:42:00 -45.0 -45.0 18.9 18.6 - - 80 0 1
6/25/2019 06:43:00 -45.0 -45.0 18.9 18.6 - - 80 0 1
6/25/2019 06:44:00 -45.0 -45.0 18.9 18.6 - - 80 0 1
6/25/2019 06:45:00 -45.0 -45.0 18.9 18.6 - - 80 0 1
6/25/2019 06:46:00 -45.0 -45.0 18.9 18.6 - - 80 0 1
6/25/2019 06:47:00 -45.0 -45.0 18.8 18.5 - - 80 0 1
6/25/2019 06:48:00 -45.0 -45.0 18.8 18.5 - - 80 0 1
6/25/2019 06:49:00 -45.0 -45.0 18.8 18.5 - - 80 0 1
6/25/2019 06:50:00 -45.0 -45.0 18.8 18.5 - - 80 0 1
6/25/2019 06:51:00 -45.0 -45.0 18.8 18.5 - - 80 0 1
6/25/2019 06:52:00 -45.0 -45.0 18.8 18.5 - - 80 0 1
6/25/2019 06:52:10 Event: - Step advanced to [5] Evacuation
6/25/2019 06:53:00 -44.8 -45.0 18.7 18.2 - 200 230 170 1
6/25/2019 06:54:00 -44.7 -45.0 18.1 13.4 - 200 230 170 1

-------------------------------------------
Approved by Date Page: 39 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 06:55:00 -44.6 -45.0 16.7 -12.4 - 200 230 170 1
6/25/2019 06:56:00 -44.5 -45.0 14.8 -34.0 - 200 230 170 1
6/25/2019 06:56:35 Event: - The condenser is cooled to -40°C.
6/25/2019 06:57:00 -44.4 -45.0 13.0 -42.8 - 200 230 170 1
6/25/2019 06:58:00 -44.3 -45.0 11.4 -46.8 - 200 230 170 1
6/25/2019 06:59:00 -44.2 -45.0 10.0 -49.0 - 200 230 170 1
6/25/2019 07:00:00 -44.2 -45.0 8.6 -50.2 - 200 230 170 1
6/25/2019 07:01:00 -44.1 -45.0 7.2 -51.2 - 200 230 170 1
6/25/2019 07:02:00 -44.1 -45.0 5.8 -52.1 - 200 230 170 1
6/25/2019 07:03:00 -44.0 -45.0 4.5 -53.0 - 200 230 170 1
6/25/2019 07:04:00 -44.0 -45.0 3.2 -53.6 - 200 230 170 1
6/25/2019 07:05:00 -43.9 -45.0 1.9 -54.0 - 200 230 170 1
6/25/2019 07:06:00 -43.8 -45.0 0.7 -54.4 - 200 230 170 1
6/25/2019 07:07:00 -43.8 -45.0 -0.4 -54.8 - 200 230 170 1
6/25/2019 07:07:50 Event: - The evacuation is started.
6/25/2019 07:08:00 -43.7 -45.0 -1.4 -54.6 - 200 230 170 -
6/25/2019 07:09:00 -43.7 -45.0 -3.0 -55.0 - 200 230 170 -
6/25/2019 07:10:00 -43.7 -45.0 -4.4 -55.9 - 200 230 170 -
6/25/2019 07:11:00 -43.7 -45.0 -5.7 -56.8 - 200 230 170 -
6/25/2019 07:12:00 -43.7 -45.0 -6.8 -57.7 - 200 230 170 -
6/25/2019 07:13:00 -43.7 -45.0 -7.9 -58.7 - 200 230 170 -
6/25/2019 07:14:00 -43.7 -45.0 -8.8 -59.9 - 200 230 170 -
6/25/2019 07:15:00 -43.7 -45.0 -9.7 -61.0 - 200 230 170 -
6/25/2019 07:16:00 -43.8 -45.0 -10.4 -62.1 - 200 230 170 -
6/25/2019 07:17:00 -43.8 -45.0 -11.0 -63.3 - 200 230 170 -
6/25/2019 07:18:00 -43.8 -45.0 -11.5 -64.5 - 200 230 170 -
6/25/2019 07:19:00 -43.8 -45.0 -11.9 -65.7 - 200 230 170 -

-------------------------------------------
Approved by Date Page: 40 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 07:20:00 -43.9 -45.0 -12.3 -66.8 - 200 230 170 -
6/25/2019 07:21:00 -43.9 -45.0 -12.7 -67.8 - 200 230 170 -
6/25/2019 07:22:00 -44.0 -45.0 -13.1 -68.6 - 200 230 170 -
6/25/2019 07:23:00 -44.1 -45.0 -13.5 -69.2 995 200 230 170 -
6/25/2019 07:24:00 -44.1 -45.0 -13.9 -69.6 504 200 230 170 584
6/25/2019 07:25:00 -44.2 -45.0 -14.2 -69.8 265 200 230 170 286
6/25/2019 07:25:35 Event: - Step advanced to [6] Drying
6/25/2019 07:26:00 -44.2 -44.0 -14.6 -70.0 205 200 230 170 209
6/25/2019 07:27:00 -42.7 -43.5 -15.1 -70.3 200 200 230 170 203
6/25/2019 07:28:00 -41.7 -43.0 -15.4 -70.7 198 200 230 170 202
6/25/2019 07:29:00 -41.2 -42.5 -15.9 -71.2 200 200 230 170 202
6/25/2019 07:30:00 -40.8 -42.0 -16.2 -71.5 200 200 230 170 200
6/25/2019 07:31:00 -40.5 -41.5 -16.6 -71.9 200 200 230 170 200
6/25/2019 07:32:00 -40.3 -41.0 -17.1 -72.3 200 200 230 170 200
6/25/2019 07:33:00 -40.0 -40.5 -17.5 -72.6 200 200 230 170 200
6/25/2019 07:34:00 -39.8 -40.1 -17.9 -72.8 200 200 230 170 200
6/25/2019 07:35:00 -39.6 -39.6 -18.3 -73.0 200 200 230 170 200
6/25/2019 07:36:00 -39.3 -39.1 -18.7 -73.2 200 200 230 170 200
6/25/2019 07:37:00 -39.2 -38.6 -19.0 -73.4 200 200 230 170 200
6/25/2019 07:38:00 -39.0 -38.0 -19.4 -73.7 200 200 230 170 201
6/25/2019 07:39:00 -38.8 -37.6 -19.8 -74.0 200 200 230 170 200
6/25/2019 07:40:00 -39.2 -37.1 -20.2 -74.2 200 200 230 170 201
6/25/2019 07:41:00 -38.9 -36.6 -20.7 -74.4 200 200 230 170 201
6/25/2019 07:42:00 -37.8 -36.1 -21.1 -74.7 200 200 230 170 200
6/25/2019 07:43:00 -36.8 -35.6 -21.5 -74.9 200 200 230 170 200
6/25/2019 07:44:00 -35.8 -35.1 -22.0 -75.1 200 200 230 170 201
6/25/2019 07:45:00 -35.0 -34.6 -22.4 -75.2 200 200 230 170 201

-------------------------------------------
Approved by Date Page: 41 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 07:46:00 -34.1 -34.1 -22.9 -75.3 199 200 230 170 201
6/25/2019 07:47:00 -33.4 -33.6 -23.7 -75.5 200 200 230 170 201
6/25/2019 07:48:00 -32.8 -33.2 -25.3 -75.6 200 200 230 170 202
6/25/2019 07:49:00 -32.4 -32.7 -34.7 -75.6 200 200 230 170 202
6/25/2019 07:50:00 -32.1 -32.2 -44.1 -75.6 200 200 230 170 202
6/25/2019 07:51:00 -31.7 -31.7 -49.1 -75.6 200 200 230 170 203
6/25/2019 07:52:00 -31.3 -31.2 -52.2 -75.6 200 200 230 170 203
6/25/2019 07:53:00 -30.8 -30.7 -54.3 -75.6 200 200 230 170 202
6/25/2019 07:54:00 -30.3 -30.2 -55.5 -75.6 200 200 230 170 201
6/25/2019 07:55:00 -29.7 -29.7 -56.1 -75.5 199 200 230 170 200
6/25/2019 07:56:00 -29.2 -29.2 -56.4 -75.3 199 200 230 170 200
6/25/2019 07:57:00 -28.7 -28.8 -56.3 -75.1 201 200 230 170 204
6/25/2019 07:58:00 -28.2 -28.3 -56.3 -74.9 200 200 230 170 202
6/25/2019 07:59:00 -27.7 -27.8 -56.3 -74.7 204 200 230 170 205
6/25/2019 08:00:00 -27.2 -27.2 -56.4 -74.4 205 200 230 170 208
6/25/2019 08:01:00 -26.7 -26.7 -56.5 -74.1 208 200 230 170 210
6/25/2019 08:02:00 -26.3 -26.2 -56.6 -73.8 202 200 230 170 203
6/25/2019 08:03:00 -25.8 -25.8 -56.9 -73.6 195 200 230 170 197
6/25/2019 08:04:00 -25.3 -25.3 -57.1 -73.3 197 200 230 170 197
6/25/2019 08:05:00 -24.8 -24.8 -57.0 -73.2 202 200 230 170 204
6/25/2019 08:06:00 -24.4 -24.3 -56.8 -73.0 205 200 230 170 206
6/25/2019 08:07:00 -23.9 -23.8 -56.6 -72.8 197 200 230 170 199
6/25/2019 08:08:00 -23.3 -23.3 -56.3 -72.6 195 200 230 170 197
6/25/2019 08:09:00 -22.8 -22.8 -56.1 -72.2 200 200 230 170 201
6/25/2019 08:10:00 -22.3 -22.4 -55.8 -71.9 205 200 230 170 206
6/25/2019 08:11:00 -21.8 -21.9 -55.7 -71.8 200 200 230 170 202
6/25/2019 08:12:00 -21.3 -21.4 -55.5 -71.6 194 200 230 170 198

-------------------------------------------
Approved by Date Page: 42 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 08:13:00 -20.9 -20.9 -55.5 -71.4 195 200 230 170 196
6/25/2019 08:14:00 -20.4 -20.3 -55.8 -71.1 204 200 230 170 202
6/25/2019 08:15:00 -20.0 -19.8 -55.8 -70.7 205 200 230 170 205
6/25/2019 08:16:00 -19.4 -19.4 -55.9 -70.3 202 200 230 170 202
6/25/2019 08:17:00 -19.0 -18.9 -56.0 -70.1 195 200 230 170 199
6/25/2019 08:18:00 -18.4 -18.4 -56.1 -69.8 194 200 230 170 197
6/25/2019 08:19:00 -17.9 -17.9 -56.2 -69.5 198 200 230 170 198
6/25/2019 08:20:00 -17.4 -17.4 -56.4 -69.2 200 200 230 170 200
6/25/2019 08:21:00 -16.9 -16.9 -56.4 -68.9 204 200 230 170 204
6/25/2019 08:22:00 -16.4 -16.4 -56.5 -68.4 202 200 230 170 202
6/25/2019 08:23:00 -15.9 -15.9 -56.5 -68.0 199 200 230 170 201
6/25/2019 08:24:00 -15.5 -15.5 -56.5 -67.6 199 200 230 170 202
6/25/2019 08:25:00 -15.0 -15.0 -56.5 -67.1 200 200 230 170 204
6/25/2019 08:26:00 -14.4 -14.5 -56.5 -66.7 200 200 230 170 204
6/25/2019 08:27:00 -14.0 -14.0 -56.5 -66.2 200 200 230 170 205
6/25/2019 08:28:00 -13.5 -13.5 -56.6 -65.7 200 200 230 170 206
6/25/2019 08:29:00 -13.0 -13.0 -56.6 -65.1 200 200 230 170 207
6/25/2019 08:30:00 -12.6 -12.5 -56.7 -64.6 200 200 230 170 209
6/25/2019 08:31:00 -12.1 -12.0 -56.5 -64.1 200 200 230 170 211
6/25/2019 08:32:00 -11.5 -11.5 -56.1 -63.7 200 200 230 170 212
6/25/2019 08:33:00 -11.0 -11.0 -55.8 -63.2 200 200 230 170 216
6/25/2019 08:34:00 -10.5 -10.5 -55.4 -62.7 200 200 230 170 217
6/25/2019 08:35:00 -10.0 -10.1 -54.8 -62.1 200 200 230 170 220
6/25/2019 08:36:00 -9.5 -9.5 -54.0 -61.5 200 200 230 170 221
6/25/2019 08:37:00 -9.1 -9.0 -53.2 -60.7 200 200 230 170 222
6/25/2019 08:38:00 -8.6 -8.5 -52.3 -60.1 200 200 230 170 223
6/25/2019 08:39:00 -8.1 -8.1 -51.4 -59.6 200 200 230 170 225

-------------------------------------------
Approved by Date Page: 43 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 08:40:00 -7.6 -7.6 -50.6 -59.2 200 200 230 170 226
6/25/2019 08:41:00 -7.0 -7.1 -49.9 -58.6 200 200 230 170 229
6/25/2019 08:42:00 -6.5 -6.6 -49.2 -57.9 200 200 230 170 230
6/25/2019 08:43:00 -6.1 -6.1 -48.6 -57.3 200 200 230 170 233
6/25/2019 08:44:00 -5.6 -5.6 -47.7 -56.5 200 200 230 170 233
6/25/2019 08:45:00 -5.2 -5.1 -46.9 -55.9 200 200 230 170 234
6/25/2019 08:46:00 -4.7 -4.6 -46.2 -55.6 200 200 230 170 234
6/25/2019 08:47:00 -4.2 -4.2 -46.0 -55.8 200 200 230 170 233
6/25/2019 08:48:00 -3.7 -3.7 -46.1 -56.1 200 200 230 170 234
6/25/2019 08:49:00 -3.2 -3.2 -46.1 -56.3 199 200 230 170 233
6/25/2019 08:50:00 -2.7 -2.6 -46.0 -56.1 200 200 230 170 234
6/25/2019 08:51:00 -2.2 -2.1 -45.9 -55.9 200 200 230 170 233
6/25/2019 08:52:00 -1.6 -1.6 -46.0 -55.7 200 200 230 170 233
6/25/2019 08:53:00 -1.1 -1.2 -47.0 -55.8 200 200 230 170 233
6/25/2019 08:54:00 -0.7 -0.7 -47.9 -56.1 200 200 230 170 231
6/25/2019 08:55:00 -0.2 -0.2 -48.3 -56.4 200 200 230 170 232
6/25/2019 08:56:00 0.3 0.3 -48.5 -56.4 200 200 230 170 230
6/25/2019 08:57:00 0.7 0.8 -49.0 -56.2 200 200 230 170 231
6/25/2019 08:58:00 1.2 1.3 -49.2 -56.0 200 200 230 170 230
6/25/2019 08:59:00 1.7 1.8 -49.3 -55.8 200 200 230 170 230
6/25/2019 09:00:00 2.1 2.3 -49.5 -55.8 200 200 230 170 228
6/25/2019 09:01:00 2.6 2.7 -49.4 -56.0 199 200 230 170 226
6/25/2019 09:02:00 3.1 3.2 -49.3 -56.4 200 200 230 170 226
6/25/2019 09:03:00 3.6 3.7 -49.4 -56.4 200 200 230 170 227
6/25/2019 09:04:00 4.1 4.2 -49.3 -56.2 200 200 230 170 227
6/25/2019 09:05:00 4.6 4.8 -49.2 -56.0 200 200 230 170 226
6/25/2019 09:05:30 Event: - Step advanced to [7] Drying

-------------------------------------------
Approved by Date Page: 44 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 09:06:00 5.1 5.0 -49.0 -55.8 199 200 230 170 224
6/25/2019 09:07:00 5.5 5.0 -49.0 -55.8 200 200 230 170 225
6/25/2019 09:08:00 5.7 5.0 -48.9 -55.6 200 200 230 170 224
6/25/2019 09:09:00 5.6 5.0 -48.7 -55.6 202 200 230 170 225
6/25/2019 09:10:00 5.3 5.0 -48.5 -55.4 200 200 230 170 224
6/25/2019 09:11:00 5.0 5.0 -48.4 -55.3 199 200 230 170 222
6/25/2019 09:12:00 4.9 5.0 -48.2 -55.1 200 200 230 170 223
6/25/2019 09:13:00 4.8 5.0 -48.0 -55.0 200 200 230 170 223
6/25/2019 09:14:00 4.8 5.0 -48.0 -55.0 200 200 230 170 225
6/25/2019 09:15:00 4.8 5.0 -48.0 -55.0 200 200 230 170 225
6/25/2019 09:16:00 4.9 5.0 -48.0 -55.0 200 200 230 170 225
6/25/2019 09:17:00 5.0 5.0 -48.2 -55.2 200 200 230 170 222
6/25/2019 09:18:00 5.1 5.0 -48.2 -55.3 199 200 230 170 222
6/25/2019 09:19:00 5.2 5.0 -48.2 -55.3 200 200 230 170 223
6/25/2019 09:20:00 5.1 5.0 -48.2 -55.3 200 200 230 170 225
6/25/2019 09:21:00 5.1 5.0 -48.2 -55.3 200 200 230 170 225
6/25/2019 09:22:00 5.0 5.0 -48.2 -55.3 200 200 230 170 225
6/25/2019 09:23:00 4.9 5.0 -48.2 -55.3 200 200 230 170 223
6/25/2019 09:24:00 4.9 5.0 -48.2 -55.3 200 200 230 170 225
6/25/2019 09:25:00 4.9 5.0 -48.3 -55.4 200 200 230 170 225
6/25/2019 09:26:00 5.0 5.0 -48.3 -55.4 200 200 230 170 225
6/25/2019 09:27:00 5.0 5.0 -48.3 -55.4 200 200 230 170 225
6/25/2019 09:28:00 5.0 5.0 -48.3 -55.4 200 200 230 170 225
6/25/2019 09:29:00 5.1 5.0 -48.3 -55.5 200 200 230 170 225
6/25/2019 09:30:00 5.1 5.0 -48.3 -55.5 200 200 230 170 223
6/25/2019 09:31:00 5.0 5.0 -48.3 -55.5 200 200 230 170 223
6/25/2019 09:32:00 5.0 5.0 -48.3 -55.5 200 200 230 170 224

-------------------------------------------
Approved by Date Page: 45 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 09:33:00 4.9 5.0 -48.2 -55.4 200 200 230 170 225
6/25/2019 09:34:00 4.9 5.0 -48.2 -55.4 200 200 230 170 225
6/25/2019 09:35:00 5.0 5.0 -48.2 -55.4 200 200 230 170 225
6/25/2019 09:36:00 5.0 5.0 -48.2 -55.4 200 200 230 170 224
6/25/2019 09:37:00 5.0 5.0 -48.1 -55.4 200 200 230 170 225
6/25/2019 09:38:00 5.0 5.0 -48.1 -55.5 200 200 230 170 225
6/25/2019 09:39:00 5.0 5.0 -48.1 -55.5 200 200 230 170 225
6/25/2019 09:40:00 5.0 5.0 -48.0 -55.4 200 200 230 170 226
6/25/2019 09:41:00 5.0 5.0 -48.0 -55.3 200 200 230 170 224
6/25/2019 09:42:00 5.1 5.0 -48.0 -55.3 200 200 230 170 224
6/25/2019 09:43:00 5.0 5.0 -47.9 -55.3 199 200 230 170 223
6/25/2019 09:44:00 5.0 5.0 -47.9 -55.3 200 200 230 170 225
6/25/2019 09:45:00 5.0 5.0 -47.9 -55.3 200 200 230 170 225
6/25/2019 09:46:00 5.0 5.0 -47.9 -55.3 199 200 230 170 224
6/25/2019 09:47:00 4.9 5.0 -47.8 -55.2 202 200 230 170 226
6/25/2019 09:48:00 5.0 5.0 -47.8 -55.2 200 200 230 170 225
6/25/2019 09:49:00 5.0 5.0 -47.7 -55.2 199 200 230 170 222
6/25/2019 09:50:00 5.0 5.0 -47.7 -55.2 200 200 230 170 226
6/25/2019 09:51:00 5.0 5.0 -47.7 -55.2 200 200 230 170 224
6/25/2019 09:52:00 5.0 5.0 -47.7 -55.1 200 200 230 170 225
6/25/2019 09:53:00 5.1 5.0 -47.7 -55.2 200 200 230 170 225
6/25/2019 09:54:00 5.1 5.0 -47.7 -55.2 201 200 230 170 226
6/25/2019 09:55:00 5.0 5.0 -47.7 -55.2 200 200 230 170 224
6/25/2019 09:56:00 5.0 5.0 -47.6 -55.1 200 200 230 170 225
6/25/2019 09:57:00 5.0 5.0 -47.6 -55.1 200 200 230 170 226
6/25/2019 09:58:00 4.9 5.0 -47.6 -55.1 200 200 230 170 225
6/25/2019 09:59:00 5.0 5.0 -47.5 -55.1 200 200 230 170 226

-------------------------------------------
Approved by Date Page: 46 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 10:00:00 5.0 5.0 -47.5 -55.2 200 200 230 170 224
6/25/2019 10:01:00 5.0 5.0 -47.6 -55.3 200 200 230 170 224
6/25/2019 10:02:00 5.0 5.0 -47.5 -55.3 200 200 230 170 226
6/25/2019 10:03:00 5.0 5.0 -47.5 -55.3 200 200 230 170 225
6/25/2019 10:04:00 5.0 5.0 -47.5 -55.2 200 200 230 170 225
6/25/2019 10:05:00 5.0 5.0 -47.5 -55.2 200 200 230 170 226
6/25/2019 10:06:00 5.1 5.0 -47.5 -55.1 200 200 230 170 225
6/25/2019 10:07:00 5.0 5.0 -47.4 -55.0 200 200 230 170 226
6/25/2019 10:08:00 5.0 5.0 -47.3 -54.9 200 200 230 170 228
6/25/2019 10:09:00 5.0 5.0 -47.3 -54.9 200 200 230 170 226
6/25/2019 10:10:00 5.0 5.0 -47.3 -55.0 200 200 230 170 226
6/25/2019 10:11:00 4.9 5.0 -47.3 -54.9 202 200 230 170 228
6/25/2019 10:12:00 5.0 5.0 -47.3 -54.8 200 200 230 170 226
6/25/2019 10:13:00 5.0 5.0 -47.3 -54.8 200 200 230 170 228
6/25/2019 10:14:00 5.0 5.0 -47.3 -54.8 200 200 230 170 228
6/25/2019 10:15:00 5.0 5.0 -47.4 -54.8 200 200 230 170 226
6/25/2019 10:16:00 5.0 5.0 -47.3 -54.8 200 200 230 170 226
6/25/2019 10:17:00 5.1 5.0 -47.3 -54.8 200 200 230 170 228
6/25/2019 10:18:00 5.1 5.0 -47.3 -54.8 200 200 230 170 228
6/25/2019 10:19:00 5.0 5.0 -47.3 -54.8 199 200 230 170 226
6/25/2019 10:20:00 5.0 5.0 -47.4 -54.8 200 200 230 170 226
6/25/2019 10:21:00 5.0 5.0 -47.4 -54.8 200 200 230 170 228
6/25/2019 10:22:00 5.0 5.0 -47.4 -54.9 200 200 230 170 228
6/25/2019 10:23:00 4.9 5.0 -47.4 -54.9 200 200 230 170 226
6/25/2019 10:24:00 5.0 5.0 -47.4 -55.0 200 200 230 170 227
6/25/2019 10:25:00 5.0 5.0 -47.4 -55.0 200 200 230 170 229
6/25/2019 10:26:00 5.0 5.0 -47.4 -55.0 200 200 230 170 228

-------------------------------------------
Approved by Date Page: 47 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 10:27:00 5.0 5.0 -47.4 -55.0 200 200 230 170 226
6/25/2019 10:28:00 5.1 5.0 -47.4 -55.0 200 200 230 170 228
6/25/2019 10:29:00 5.0 5.0 -47.4 -55.0 200 200 230 170 228
6/25/2019 10:30:00 5.0 5.0 -47.4 -55.0 200 200 230 170 228
6/25/2019 10:31:00 5.0 5.0 -47.4 -54.9 200 200 230 170 229
6/25/2019 10:32:00 5.0 5.0 -47.3 -54.9 200 200 230 170 229
6/25/2019 10:33:00 5.0 5.0 -47.3 -54.8 200 200 230 170 228
6/25/2019 10:34:00 5.0 5.0 -47.3 -54.9 202 200 230 170 229
6/25/2019 10:35:00 4.9 5.0 -47.3 -54.9 200 200 230 170 228
6/25/2019 10:36:00 5.0 5.0 -47.3 -54.9 200 200 230 170 228
6/25/2019 10:37:00 5.0 5.0 -47.3 -54.9 200 200 230 170 229
6/25/2019 10:38:00 5.0 5.0 -47.3 -54.9 200 200 230 170 229
6/25/2019 10:39:00 5.0 5.0 -47.3 -54.9 200 200 230 170 228
6/25/2019 10:40:00 5.1 5.0 -47.3 -54.9 200 200 230 170 229
6/25/2019 10:41:00 5.0 5.0 -47.3 -54.9 200 200 230 170 228
6/25/2019 10:42:00 5.0 5.0 -47.3 -54.9 200 200 230 170 228
6/25/2019 10:43:00 5.0 5.0 -47.2 -54.9 200 200 230 170 229
6/25/2019 10:44:00 5.0 5.0 -47.2 -54.8 200 200 230 170 229
6/25/2019 10:45:00 5.0 5.0 -47.2 -54.9 200 200 230 170 229
6/25/2019 10:46:00 5.0 5.0 -47.2 -54.8 200 200 230 170 230
6/25/2019 10:47:00 4.9 5.0 -47.2 -54.8 199 200 230 170 228
6/25/2019 10:48:00 4.9 5.0 -47.2 -54.8 200 200 230 170 229
6/25/2019 10:49:00 5.0 5.0 -47.2 -54.8 200 200 230 170 230
6/25/2019 10:50:00 5.0 5.0 -47.2 -54.8 200 200 230 170 229
6/25/2019 10:51:00 5.0 5.0 -47.2 -54.8 200 200 230 170 228
6/25/2019 10:52:00 5.1 5.0 -47.2 -54.8 200 200 230 170 230
6/25/2019 10:53:00 5.1 5.0 -47.1 -54.8 200 200 230 170 230

-------------------------------------------
Approved by Date Page: 48 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 10:54:00 5.0 5.0 -47.2 -54.8 200 200 230 170 229
6/25/2019 10:55:00 5.0 5.0 -47.1 -54.8 200 200 230 170 230
6/25/2019 10:56:00 5.0 5.0 -47.1 -54.8 200 200 230 170 229
6/25/2019 10:57:00 5.0 5.0 -47.1 -54.8 200 200 230 170 230
6/25/2019 10:58:00 5.0 5.0 -47.1 -54.8 200 200 230 170 230
6/25/2019 10:59:00 5.0 5.0 -47.2 -54.8 200 200 230 170 229
6/25/2019 11:00:00 5.0 5.0 -47.1 -54.7 200 200 230 170 230
6/25/2019 11:01:00 4.9 5.0 -47.2 -54.8 200 200 230 170 230
6/25/2019 11:02:00 5.0 5.0 -47.2 -54.7 200 200 230 170 229
6/25/2019 11:03:00 5.0 5.0 -47.2 -54.7 200 200 230 170 230
6/25/2019 11:04:00 5.0 5.0 -47.2 -54.7 199 200 230 170 229
6/25/2019 11:05:00 5.1 5.0 -47.2 -54.7 200 200 230 170 229
6/25/2019 11:06:00 5.1 5.0 -47.2 -54.8 200 200 230 170 230
6/25/2019 11:07:00 5.0 5.0 -47.2 -54.8 200 200 230 170 229
6/25/2019 11:08:00 5.0 5.0 -47.1 -54.8 202 200 230 170 232
6/25/2019 11:09:00 5.0 5.0 -47.1 -54.8 200 200 230 170 229
6/25/2019 11:10:00 5.0 5.0 -47.1 -54.7 200 200 230 170 230
6/25/2019 11:11:00 5.0 5.0 -47.1 -54.8 200 200 230 170 229
6/25/2019 11:12:00 5.0 5.0 -47.2 -54.8 200 200 230 170 230
6/25/2019 11:13:00 5.0 5.0 -47.2 -54.7 200 200 230 170 232
6/25/2019 11:14:00 5.0 5.0 -47.3 -54.7 202 200 230 170 232
6/25/2019 11:15:00 5.0 5.0 -47.4 -54.7 199 200 230 170 229
6/25/2019 11:16:00 5.0 5.0 -47.4 -54.7 200 200 230 170 232
6/25/2019 11:17:00 5.0 5.0 -47.4 -54.7 200 200 230 170 230
6/25/2019 11:18:00 5.0 5.0 -47.3 -54.7 200 200 230 170 232
6/25/2019 11:19:00 5.0 5.0 -47.3 -54.8 200 200 230 170 230
6/25/2019 11:20:00 5.0 5.0 -47.3 -54.7 200 200 230 170 232

-------------------------------------------
Approved by Date Page: 49 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 11:21:00 5.0 5.0 -47.4 -54.7 199 200 230 170 230
6/25/2019 11:22:00 5.0 5.0 -47.4 -54.7 200 200 230 170 232
6/25/2019 11:23:00 5.0 5.0 -47.4 -54.7 200 200 230 170 230
6/25/2019 11:24:00 5.0 5.0 -47.4 -54.7 200 200 230 170 230
6/25/2019 11:25:00 5.1 5.0 -47.5 -54.7 200 200 230 170 232
6/25/2019 11:26:00 5.0 5.0 -47.4 -54.7 199 200 230 170 230
6/25/2019 11:27:00 5.0 5.0 -47.5 -54.7 200 200 230 170 232
6/25/2019 11:28:00 5.0 5.0 -47.4 -54.7 200 200 230 170 232
6/25/2019 11:29:00 5.0 5.0 -47.4 -54.7 200 200 230 170 230
6/25/2019 11:30:00 5.0 5.0 -47.4 -54.7 200 200 230 170 232
6/25/2019 11:31:00 5.0 5.0 -47.4 -54.7 200 200 230 170 230
6/25/2019 11:32:00 5.0 5.0 -47.4 -54.6 200 200 230 170 232
6/25/2019 11:33:00 5.0 5.0 -47.5 -54.7 200 200 230 170 230
6/25/2019 11:34:00 5.0 5.0 -47.4 -54.6 200 200 230 170 232
6/25/2019 11:35:00 5.0 5.0 -47.4 -54.6 200 200 230 170 230
6/25/2019 11:36:00 5.0 5.0 -47.5 -54.7 200 200 230 170 232
6/25/2019 11:37:00 5.0 5.0 -47.5 -54.6 200 200 230 170 232
6/25/2019 11:38:00 5.0 5.0 -47.4 -54.5 199 200 230 170 230
6/25/2019 11:39:00 5.0 5.0 -47.4 -54.5 200 200 230 170 232
6/25/2019 11:40:00 5.0 5.0 -47.4 -54.5 200 200 230 170 232
6/25/2019 11:41:00 5.0 5.0 -47.4 -54.5 200 200 230 170 232
6/25/2019 11:42:00 5.0 5.0 -47.3 -54.5 200 200 230 170 232
6/25/2019 11:43:00 5.0 5.0 -47.4 -54.5 200 200 230 170 232
6/25/2019 11:44:00 5.0 5.0 -47.4 -54.6 200 200 230 170 232
6/25/2019 11:45:00 5.0 5.0 -47.4 -54.5 200 200 230 170 232
6/25/2019 11:46:00 5.0 5.0 -47.4 -54.6 200 200 230 170 233
6/25/2019 11:47:00 5.0 5.0 -47.4 -54.6 200 200 230 170 233

-------------------------------------------
Approved by Date Page: 50 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 11:48:00 5.0 5.0 -47.3 -54.5 200 200 230 170 232
6/25/2019 11:49:00 5.0 5.0 -47.3 -54.5 200 200 230 170 232
6/25/2019 11:50:00 5.0 5.0 -47.3 -54.5 200 200 230 170 233
6/25/2019 11:51:00 5.0 5.0 -47.3 -54.6 200 200 230 170 233
6/25/2019 11:52:00 5.0 5.0 -47.3 -54.6 200 200 230 170 232
6/25/2019 11:53:00 5.0 5.0 -47.3 -54.6 200 200 230 170 233
6/25/2019 11:54:00 5.0 5.0 -47.3 -54.5 200 200 230 170 233
6/25/2019 11:55:00 5.0 5.0 -47.3 -54.5 200 200 230 170 229
6/25/2019 11:56:00 5.1 5.0 -47.3 -54.6 200 200 230 170 233
6/25/2019 11:57:00 5.1 5.0 -47.3 -54.6 200 200 230 170 232
6/25/2019 11:58:00 5.0 5.0 -47.3 -54.6 200 200 230 170 233
6/25/2019 11:59:00 5.0 5.0 -47.3 -54.6 200 200 230 170 233
6/25/2019 12:00:00 5.1 5.0 -47.3 -54.6 200 200 230 170 233
6/25/2019 12:01:00 5.0 5.0 -47.3 -54.6 199 200 230 170 232
6/25/2019 12:02:00 5.0 5.0 -47.4 -54.7 200 200 230 170 233
6/25/2019 12:03:00 5.0 5.0 -47.3 -54.7 200 200 230 170 233
6/25/2019 12:04:00 4.9 5.0 -47.4 -54.7 200 200 230 170 233
6/25/2019 12:05:00 4.9 5.0 -47.4 -54.7 200 200 230 170 232
6/25/2019 12:06:00 5.0 5.0 -47.4 -54.7 200 200 230 170 232
6/25/2019 12:07:00 5.0 5.0 -47.4 -54.7 200 200 230 170 233
6/25/2019 12:08:00 5.0 5.0 -47.4 -54.7 200 200 230 170 234
6/25/2019 12:09:00 5.0 5.0 -47.4 -54.7 200 200 230 170 232
6/25/2019 12:10:00 5.0 5.0 -47.4 -54.7 200 200 230 170 233
6/25/2019 12:11:00 5.0 5.0 -47.4 -54.7 200 200 230 170 233
6/25/2019 12:12:00 5.1 5.0 -47.4 -54.7 200 200 230 170 233
6/25/2019 12:13:00 5.1 5.0 -47.4 -54.7 200 200 230 170 233
6/25/2019 12:14:00 5.1 5.0 -47.4 -54.7 200 200 230 170 233

-------------------------------------------
Approved by Date Page: 51 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 12:15:00 5.0 5.0 -47.4 -54.7 200 200 230 170 234
6/25/2019 12:16:00 5.0 5.0 -47.4 -54.7 200 200 230 170 233
6/25/2019 12:17:00 5.0 5.0 -47.4 -54.6 200 200 230 170 233
6/25/2019 12:18:00 5.0 5.0 -47.4 -54.6 202 200 230 170 233
6/25/2019 12:19:00 4.9 5.0 -47.3 -54.6 199 200 230 170 233
6/25/2019 12:20:00 4.9 5.0 -47.4 -54.7 200 200 230 170 234
6/25/2019 12:21:00 5.0 5.0 -47.4 -54.6 200 200 230 170 234
6/25/2019 12:22:00 5.0 5.0 -47.4 -54.6 200 200 230 170 233
6/25/2019 12:23:00 5.0 5.0 -47.4 -54.6 200 200 230 170 234
6/25/2019 12:24:00 5.0 5.0 -47.4 -54.7 200 200 230 170 233
6/25/2019 12:25:00 5.1 5.0 -47.4 -54.7 200 200 230 170 234
6/25/2019 12:26:00 5.0 5.0 -47.4 -54.6 199 200 230 170 233
6/25/2019 12:27:00 5.0 5.0 -47.4 -54.7 200 200 230 170 234
6/25/2019 12:28:00 5.0 5.0 -47.4 -54.6 200 200 230 170 234
6/25/2019 12:29:00 5.0 5.0 -47.4 -54.6 200 200 230 170 234
6/25/2019 12:30:00 5.0 5.0 -47.4 -54.7 200 200 230 170 234
6/25/2019 12:31:00 4.9 5.0 -47.4 -54.7 199 200 230 170 233
6/25/2019 12:32:00 4.9 5.0 -47.4 -54.7 200 200 230 170 233
6/25/2019 12:33:00 4.9 5.0 -47.4 -54.6 200 200 230 170 232
6/25/2019 12:34:00 5.0 5.0 -47.4 -54.6 200 200 230 170 234
6/25/2019 12:35:00 5.0 5.0 -47.4 -54.6 200 200 230 170 234
6/25/2019 12:36:00 5.0 5.0 -47.4 -54.7 200 200 230 170 234
6/25/2019 12:37:00 5.0 5.0 -47.4 -54.7 202 200 230 170 234
6/25/2019 12:38:00 5.0 5.0 -47.4 -54.7 199 200 230 170 233
6/25/2019 12:39:00 5.0 5.0 -47.4 -54.7 200 200 230 170 234
6/25/2019 12:40:00 5.0 5.0 -47.4 -54.7 200 200 230 170 234
6/25/2019 12:41:00 5.1 5.0 -47.4 -54.7 200 200 230 170 233

-------------------------------------------
Approved by Date Page: 52 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 12:42:00 5.0 5.0 -47.4 -54.7 200 200 230 170 233
6/25/2019 12:43:00 5.0 5.0 -47.4 -54.7 199 200 230 170 234
6/25/2019 12:44:00 5.0 5.0 -47.4 -54.7 199 200 230 170 233
6/25/2019 12:45:00 5.0 5.0 -47.4 -54.7 199 200 230 170 233
6/25/2019 12:46:00 4.9 5.0 -47.4 -54.7 200 200 230 170 234
6/25/2019 12:47:00 4.9 5.0 -47.4 -54.7 200 200 230 170 234
6/25/2019 12:48:00 5.0 5.0 -47.4 -54.7 200 200 230 170 236
6/25/2019 12:49:00 5.0 5.0 -47.4 -54.7 200 200 230 170 234
6/25/2019 12:50:00 5.0 5.0 -47.4 -54.8 199 200 230 170 233
6/25/2019 12:51:00 5.1 5.0 -47.5 -54.8 200 200 230 170 234
6/25/2019 12:52:00 5.1 5.0 -47.5 -54.8 200 200 230 170 234
6/25/2019 12:53:00 5.0 5.0 -47.5 -54.8 202 200 230 170 236
6/25/2019 12:54:00 5.0 5.0 -47.5 -54.8 200 200 230 170 234
6/25/2019 12:55:00 5.0 5.0 -47.5 -54.8 200 200 230 170 234
6/25/2019 12:56:00 5.0 5.0 -47.5 -54.8 200 200 230 170 234
6/25/2019 12:57:00 4.9 5.0 -47.5 -54.9 200 200 230 170 236
6/25/2019 12:58:00 4.9 5.0 -47.4 -54.8 200 200 230 170 234
6/25/2019 12:59:00 5.0 5.0 -47.5 -54.8 200 200 230 170 235
6/25/2019 13:00:00 5.0 5.0 -47.5 -54.8 200 200 230 170 236
6/25/2019 13:01:00 5.0 5.0 -47.5 -54.8 202 200 230 170 236
6/25/2019 13:02:00 5.0 5.0 -47.5 -54.8 200 200 230 170 236
6/25/2019 13:03:00 5.0 5.0 -47.5 -54.8 200 200 230 170 236
6/25/2019 13:04:00 5.0 5.0 -47.5 -54.8 200 200 230 170 234
6/25/2019 13:05:00 5.0 5.0 -47.5 -54.8 200 200 230 170 235
6/25/2019 13:06:00 5.1 5.0 -47.4 -54.8 199 200 230 170 233
6/25/2019 13:07:00 5.0 5.0 -47.4 -54.9 199 200 230 170 234
6/25/2019 13:08:00 5.0 5.0 -47.5 -54.9 200 200 230 170 234

-------------------------------------------
Approved by Date Page: 53 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 13:09:00 5.0 5.0 -47.5 -54.9 200 200 230 170 236
6/25/2019 13:10:00 5.0 5.0 -47.5 -54.9 200 200 230 170 236
6/25/2019 13:11:00 5.0 5.0 -47.4 -54.8 200 200 230 170 236
6/25/2019 13:12:00 4.9 5.0 -47.4 -54.8 200 200 230 170 237
6/25/2019 13:13:00 4.9 5.0 -47.4 -54.9 200 200 230 170 234
6/25/2019 13:14:00 5.0 5.0 -47.4 -54.9 200 200 230 170 237
6/25/2019 13:15:00 5.0 5.0 -47.4 -54.9 200 200 230 170 236
6/25/2019 13:16:00 5.0 5.0 -47.4 -54.9 199 200 230 170 234
6/25/2019 13:17:00 5.0 5.0 -47.4 -54.9 200 200 230 170 234
6/25/2019 13:18:00 5.0 5.0 -47.4 -54.8 200 200 230 170 234
6/25/2019 13:19:00 5.1 5.0 -47.3 -54.9 199 200 230 170 234
6/25/2019 13:20:00 5.0 5.0 -47.3 -54.9 200 200 230 170 236
6/25/2019 13:21:00 5.0 5.0 -47.3 -54.9 202 200 230 170 237
6/25/2019 13:22:00 5.0 5.0 -47.3 -55.0 201 200 230 170 237
6/25/2019 13:23:00 5.0 5.0 -47.3 -54.9 200 200 230 170 234
6/25/2019 13:24:00 5.0 5.0 -47.2 -55.0 200 200 230 170 236
6/25/2019 13:25:00 5.0 5.0 -47.2 -54.9 199 200 230 170 236
6/25/2019 13:26:00 5.0 5.0 -47.2 -55.0 200 200 230 170 236
6/25/2019 13:27:00 5.0 5.0 -47.2 -55.0 200 200 230 170 236
6/25/2019 13:28:00 5.0 5.0 -47.2 -55.0 200 200 230 170 236
6/25/2019 13:29:00 5.0 5.0 -47.2 -55.0 199 200 230 170 236
6/25/2019 13:30:00 5.0 5.0 -47.2 -55.0 200 200 230 170 237
6/25/2019 13:31:00 5.0 5.0 -47.2 -55.0 200 200 230 170 236
6/25/2019 13:32:00 5.0 5.0 -47.2 -55.0 202 200 230 170 237
6/25/2019 13:33:00 5.0 5.0 -47.2 -55.0 199 200 230 170 236
6/25/2019 13:34:00 5.0 5.0 -47.2 -55.0 200 200 230 170 237
6/25/2019 13:35:00 5.0 5.0 -47.2 -55.0 200 200 230 170 237

-------------------------------------------
Approved by Date Page: 54 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 13:36:00 5.0 5.0 -47.2 -55.0 200 200 230 170 237
6/25/2019 13:37:00 5.0 5.0 -47.2 -55.1 200 200 230 170 236
6/25/2019 13:38:00 5.0 5.0 -47.2 -55.1 200 200 230 170 237
6/25/2019 13:39:00 5.0 5.0 -47.2 -55.1 200 200 230 170 237
6/25/2019 13:40:00 5.0 5.0 -47.2 -55.1 200 200 230 170 237
6/25/2019 13:41:00 5.0 5.0 -47.2 -55.1 200 200 230 170 236
6/25/2019 13:42:00 5.0 5.0 -47.2 -55.0 200 200 230 170 237
6/25/2019 13:43:00 5.0 5.0 -47.2 -55.1 200 200 230 170 236
6/25/2019 13:44:00 5.0 5.0 -47.2 -55.1 200 200 230 170 235
6/25/2019 13:45:00 5.0 5.0 -47.2 -55.1 202 200 230 170 237
6/25/2019 13:46:00 5.0 5.0 -47.2 -55.1 200 200 230 170 237
6/25/2019 13:47:00 5.0 5.0 -47.2 -55.1 199 200 230 170 235
6/25/2019 13:48:00 5.0 5.0 -47.2 -55.1 200 200 230 170 237
6/25/2019 13:49:00 5.0 5.0 -47.2 -55.1 199 200 230 170 236
6/25/2019 13:50:00 5.0 5.0 -47.3 -55.2 200 200 230 170 237
6/25/2019 13:51:00 5.0 5.0 -47.3 -55.1 200 200 230 170 237
6/25/2019 13:52:00 5.0 5.0 -47.3 -55.2 199 200 230 170 236
6/25/2019 13:53:00 5.0 5.0 -47.3 -55.2 200 200 230 170 237
6/25/2019 13:54:00 5.0 5.0 -47.3 -55.2 200 200 230 170 237
6/25/2019 13:55:00 5.0 5.0 -47.3 -55.2 200 200 230 170 235
6/25/2019 13:56:00 5.0 5.0 -47.3 -55.2 200 200 230 170 237
6/25/2019 13:57:00 5.0 5.0 -47.3 -55.2 200 200 230 170 237
6/25/2019 13:58:00 5.0 5.0 -47.3 -55.2 200 200 230 170 238
6/25/2019 13:59:00 5.0 5.0 -47.3 -55.3 200 200 230 170 236
6/25/2019 14:00:00 4.9 5.0 -47.3 -55.3 200 200 230 170 237
6/25/2019 14:01:00 5.0 5.0 -47.3 -55.3 200 200 230 170 237
6/25/2019 14:02:00 5.0 5.0 -47.3 -55.3 200 200 230 170 237

-------------------------------------------
Approved by Date Page: 55 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 14:03:00 5.0 5.0 -47.3 -55.3 200 200 230 170 237
6/25/2019 14:04:00 5.0 5.0 -47.3 -55.3 200 200 230 170 237
6/25/2019 14:05:00 5.0 5.0 -47.3 -55.3 199 200 230 170 237
6/25/2019 14:06:00 5.1 5.0 -47.3 -55.3 200 200 230 170 237
6/25/2019 14:07:00 5.0 5.0 -47.3 -55.3 199 200 230 170 236
6/25/2019 14:08:00 5.1 5.0 -47.3 -55.3 199 200 230 170 237
6/25/2019 14:09:00 5.0 5.0 -47.3 -55.4 200 200 230 170 238
6/25/2019 14:10:00 5.0 5.0 -47.3 -55.4 200 200 230 170 238
6/25/2019 14:11:00 4.9 5.0 -47.3 -55.4 200 200 230 170 238
6/25/2019 14:12:00 4.9 5.0 -47.3 -55.4 199 200 230 170 237
6/25/2019 14:13:00 5.0 5.0 -47.3 -55.3 200 200 230 170 238
6/25/2019 14:14:00 5.0 5.0 -47.3 -55.4 199 200 230 170 237
6/25/2019 14:15:00 5.0 5.0 -47.3 -55.4 200 200 230 170 238
6/25/2019 14:16:00 5.0 5.0 -47.3 -55.4 200 200 230 170 237
6/25/2019 14:17:00 5.0 5.0 -47.3 -55.5 200 200 230 170 238
6/25/2019 14:18:00 5.0 5.0 -47.3 -55.5 200 200 230 170 238
6/25/2019 14:19:00 5.1 5.0 -47.3 -55.5 200 200 230 170 237
6/25/2019 14:20:00 5.1 5.0 -47.2 -55.5 200 200 230 170 237
6/25/2019 14:21:00 5.0 5.0 -47.3 -55.5 200 200 230 170 238
6/25/2019 14:22:00 5.0 5.0 -47.3 -55.5 200 200 230 170 237
6/25/2019 14:23:00 5.0 5.0 -47.3 -55.5 199 200 230 170 237
6/25/2019 14:24:00 5.0 5.0 -47.2 -55.6 202 200 230 170 238
6/25/2019 14:25:00 4.9 5.0 -47.3 -55.6 200 200 230 170 238
6/25/2019 14:26:00 5.0 5.0 -47.3 -55.6 200 200 230 170 238
6/25/2019 14:27:00 4.9 5.0 -47.3 -55.6 200 200 230 170 240
6/25/2019 14:28:00 5.0 5.0 -47.3 -55.6 202 200 230 170 240
6/25/2019 14:29:00 5.0 5.0 -47.3 -55.6 200 200 230 170 240

-------------------------------------------
Approved by Date Page: 56 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 14:30:00 5.0 5.0 -47.3 -55.7 200 200 230 170 238
6/25/2019 14:31:00 5.0 5.0 -47.3 -55.7 200 200 230 170 240
6/25/2019 14:32:00 5.0 5.0 -47.3 -55.7 200 200 230 170 238
6/25/2019 14:33:00 5.0 5.0 -47.3 -55.7 200 200 230 170 240
6/25/2019 14:34:00 5.0 5.0 -47.3 -55.8 200 200 230 170 240
6/25/2019 14:35:00 5.0 5.0 -47.3 -55.7 200 200 230 170 238
6/25/2019 14:36:00 5.0 5.0 -47.3 -55.7 200 200 230 170 238
6/25/2019 14:37:00 5.0 5.0 -47.3 -55.8 200 200 230 170 238
6/25/2019 14:38:00 5.0 5.0 -47.3 -55.8 200 200 230 170 238
6/25/2019 14:39:00 5.0 5.0 -47.3 -55.8 200 200 230 170 238
6/25/2019 14:40:00 5.0 5.0 -47.3 -55.9 200 200 230 170 238
6/25/2019 14:41:00 5.0 5.0 -47.3 -55.9 200 200 230 170 237
6/25/2019 14:42:00 5.0 5.0 -47.3 -55.9 200 200 230 170 238
6/25/2019 14:43:00 5.0 5.0 -47.4 -55.9 200 200 230 170 239
6/25/2019 14:44:00 5.0 5.0 -47.4 -55.9 200 200 230 170 240
6/25/2019 14:45:00 5.0 5.0 -47.4 -55.9 199 200 230 170 238
6/25/2019 14:46:00 5.0 5.0 -47.3 -55.9 200 200 230 170 240
6/25/2019 14:47:00 5.0 5.0 -47.3 -55.9 199 200 230 170 238
6/25/2019 14:48:00 5.0 5.0 -47.4 -56.0 199 200 230 170 238
6/25/2019 14:49:00 5.0 5.0 -47.4 -56.0 200 200 230 170 238
6/25/2019 14:50:00 5.1 5.0 -47.4 -56.0 200 200 230 170 237
6/25/2019 14:51:00 5.0 5.0 -47.4 -56.0 200 200 230 170 238
6/25/2019 14:52:00 5.0 5.0 -47.4 -56.0 200 200 230 170 237
6/25/2019 14:53:00 5.0 5.0 -47.4 -56.0 199 200 230 170 238
6/25/2019 14:54:00 5.0 5.0 -47.4 -56.1 199 200 230 170 238
6/25/2019 14:55:00 5.0 5.0 -47.4 -56.1 200 200 230 170 238
6/25/2019 14:56:00 5.0 5.0 -47.4 -56.2 200 200 230 170 237

-------------------------------------------
Approved by Date Page: 57 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 14:57:00 5.0 5.0 -47.4 -56.2 200 200 230 170 238
6/25/2019 14:58:00 5.0 5.0 -47.4 -56.2 200 200 230 170 237
6/25/2019 14:59:00 5.0 5.0 -47.4 -56.2 200 200 230 170 237
6/25/2019 15:00:00 5.0 5.0 -47.4 -56.3 200 200 230 170 237
6/25/2019 15:01:00 5.0 5.0 -47.4 -56.3 200 200 230 170 237
6/25/2019 15:02:00 5.0 5.0 -47.4 -56.4 200 200 230 170 236
6/25/2019 15:03:00 5.0 5.0 -47.4 -56.4 202 200 230 170 237
6/25/2019 15:04:00 5.0 5.0 -47.4 -56.5 200 200 230 170 237
6/25/2019 15:05:00 5.0 5.0 -47.4 -56.5 200 200 230 170 235
6/25/2019 15:06:00 5.0 5.0 -47.5 -56.6 200 200 230 170 235
6/25/2019 15:07:00 5.0 5.0 -47.5 -56.6 200 200 230 170 237
6/25/2019 15:08:00 5.0 5.0 -47.5 -56.6 201 200 230 170 237
6/25/2019 15:09:00 5.0 5.0 -47.5 -56.5 200 200 230 170 237
6/25/2019 15:10:00 5.0 5.0 -47.5 -56.4 200 200 230 170 237
6/25/2019 15:11:00 5.0 5.0 -47.5 -56.3 200 200 230 170 237
6/25/2019 15:12:00 5.0 5.0 -47.5 -55.9 200 200 230 170 237
6/25/2019 15:13:00 5.0 5.0 -47.5 -55.7 200 200 230 170 237
6/25/2019 15:14:00 5.0 5.0 -47.5 -55.5 200 200 230 170 237
6/25/2019 15:15:00 5.0 5.0 -47.5 -55.5 202 200 230 170 237
6/25/2019 15:16:00 5.0 5.0 -47.5 -55.5 200 200 230 170 238
6/25/2019 15:17:00 5.0 5.0 -47.5 -55.5 200 200 230 170 238
6/25/2019 15:18:00 5.0 5.0 -47.5 -55.5 200 200 230 170 237
6/25/2019 15:19:00 5.0 5.0 -47.5 -55.6 200 200 230 170 237
6/25/2019 15:20:00 5.0 5.0 -47.6 -55.7 200 200 230 170 237
6/25/2019 15:21:00 5.0 5.0 -47.6 -55.9 200 200 230 170 237
6/25/2019 15:22:00 5.0 5.0 -47.6 -56.1 202 200 230 170 237
6/25/2019 15:23:00 5.0 5.0 -47.6 -56.3 200 200 230 170 237

-------------------------------------------
Approved by Date Page: 58 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 15:24:00 5.1 5.0 -47.6 -56.6 200 200 230 170 237
6/25/2019 15:25:00 5.0 5.0 -47.6 -56.9 200 200 230 170 237
6/25/2019 15:26:00 5.0 5.0 -47.6 -57.1 200 200 230 170 236
6/25/2019 15:27:00 5.0 5.0 -47.7 -57.2 200 200 230 170 237
6/25/2019 15:28:00 5.0 5.0 -47.7 -57.2 200 200 230 170 237
6/25/2019 15:29:00 5.0 5.0 -47.7 -57.3 200 200 230 170 237
6/25/2019 15:30:00 5.0 5.0 -47.7 -57.3 200 200 230 170 237
6/25/2019 15:31:00 5.0 5.0 -47.7 -57.4 200 200 230 170 236
6/25/2019 15:32:00 5.0 5.0 -47.7 -57.4 200 200 230 170 237
6/25/2019 15:33:00 5.0 5.0 -47.7 -57.5 200 200 230 170 237
6/25/2019 15:34:00 5.0 5.0 -47.8 -57.5 200 200 230 170 237
6/25/2019 15:35:00 5.1 5.0 -47.8 -57.6 200 200 230 170 237
6/25/2019 15:36:00 5.0 5.0 -47.8 -57.6 200 200 230 170 238
6/25/2019 15:37:00 5.0 5.0 -47.8 -57.6 200 200 230 170 237
6/25/2019 15:38:00 5.0 5.0 -47.8 -57.6 200 200 230 170 237
6/25/2019 15:38:48 Audit: - A_HTRFAIL ALARM is acknowledged by IDIN.
6/25/2019 15:39:00 5.0 5.0 -47.8 -57.6 200 200 230 170 237
6/25/2019 15:40:00 5.0 5.0 -47.9 -57.7 200 200 230 170 238
6/25/2019 15:41:00 5.0 5.0 -47.9 -57.7 200 200 230 170 238
6/25/2019 15:42:00 5.0 5.0 -47.9 -57.7 200 200 230 170 238
6/25/2019 15:43:00 5.0 5.0 -47.9 -57.8 199 200 230 170 236
6/25/2019 15:44:00 4.9 5.0 -48.0 -57.9 199 200 230 170 237
6/25/2019 15:45:00 5.0 5.0 -48.0 -57.9 200 200 230 170 237
6/25/2019 15:46:00 5.0 5.0 -48.0 -57.9 200 200 230 170 237
6/25/2019 15:47:00 5.0 5.0 -48.0 -58.0 200 200 230 170 237
6/25/2019 15:48:00 5.0 5.0 -48.0 -58.0 200 200 230 170 237
6/25/2019 15:49:00 5.0 5.0 -48.0 -58.0 200 200 230 170 237

-------------------------------------------
Approved by Date Page: 59 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 15:50:00 5.0 5.0 -48.0 -58.1 200 200 230 170 237
6/25/2019 15:51:00 5.0 5.0 -48.0 -58.1 200 200 230 170 237
6/25/2019 15:52:00 5.0 5.0 -48.1 -58.2 200 200 230 170 237
6/25/2019 15:53:00 5.0 5.0 -48.1 -58.2 200 200 230 170 237
6/25/2019 15:54:00 5.0 5.0 -48.1 -58.3 200 200 230 170 237
6/25/2019 15:55:00 5.0 5.0 -48.1 -58.3 200 200 230 170 237
6/25/2019 15:56:00 5.0 5.0 -48.1 -58.4 200 200 230 170 237
6/25/2019 15:57:00 5.0 5.0 -48.1 -58.4 200 200 230 170 237
6/25/2019 15:58:00 5.1 5.0 -48.2 -58.4 200 200 230 170 237
6/25/2019 15:59:00 5.1 5.0 -48.2 -58.5 200 200 230 170 238
6/25/2019 16:00:00 5.0 5.0 -48.2 -58.5 200 200 230 170 240
6/25/2019 16:01:00 5.0 5.0 -48.2 -58.6 200 200 230 170 237
6/25/2019 16:02:00 5.0 5.0 -48.2 -58.6 200 200 230 170 237
6/25/2019 16:03:00 4.9 5.0 -48.2 -58.7 200 200 230 170 235
6/25/2019 16:04:00 5.0 5.0 -48.3 -58.7 200 200 230 170 234
6/25/2019 16:05:00 4.9 5.0 -48.3 -58.8 200 200 230 170 236
6/25/2019 16:06:00 5.0 5.0 -48.4 -58.8 200 200 230 170 234
6/25/2019 16:07:00 5.0 5.0 -48.5 -58.9 201 200 230 170 236
6/25/2019 16:08:00 5.0 5.0 -48.6 -59.0 202 200 230 170 237
6/25/2019 16:09:00 5.0 5.0 -48.8 -58.9 199 200 230 170 234
6/25/2019 16:10:00 5.0 5.0 -49.2 -59.0 200 200 230 170 234
6/25/2019 16:11:00 5.0 5.0 -52.7 -59.1 200 200 230 170 234
6/25/2019 16:12:00 5.0 5.0 -55.4 -59.1 200 200 230 170 235
6/25/2019 16:13:00 5.0 5.0 -56.3 -59.1 200 200 230 170 234
6/25/2019 16:14:00 5.0 5.0 -56.6 -59.2 200 200 230 170 234
6/25/2019 16:15:00 5.0 5.0 -56.6 -59.2 200 200 230 170 234
6/25/2019 16:16:00 5.0 5.0 -56.6 -59.2 200 200 230 170 233

-------------------------------------------
Approved by Date Page: 60 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 16:17:00 5.1 5.0 -56.7 -59.2 200 200 230 170 233
6/25/2019 16:18:00 5.0 5.0 -56.7 -59.3 200 200 230 170 233
6/25/2019 16:19:00 5.0 5.0 -56.7 -59.3 200 200 230 170 233
6/25/2019 16:20:00 5.0 5.0 -56.7 -59.3 200 200 230 170 232
6/25/2019 16:21:00 5.0 5.0 -56.8 -59.4 200 200 230 170 232
6/25/2019 16:22:00 5.0 5.0 -56.8 -59.5 200 200 230 170 231
6/25/2019 16:23:00 5.0 5.0 -56.8 -59.5 200 200 230 170 232
6/25/2019 16:24:00 5.0 5.0 -56.9 -59.6 200 200 230 170 232
6/25/2019 16:25:00 5.0 5.0 -56.9 -59.6 200 200 230 170 232
6/25/2019 16:26:00 5.0 5.0 -56.8 -59.7 200 200 230 170 230
6/25/2019 16:27:00 5.0 5.0 -56.9 -59.7 200 200 230 170 230
6/25/2019 16:28:00 5.0 5.0 -56.9 -59.8 200 200 230 170 230
6/25/2019 16:29:00 5.0 5.0 -56.9 -59.8 199 200 230 170 230
6/25/2019 16:30:00 5.0 5.0 -56.9 -59.9 200 200 230 170 233
6/25/2019 16:31:00 5.0 5.0 -56.9 -60.0 200 200 230 170 233
6/25/2019 16:32:00 5.0 5.0 -56.9 -60.0 200 200 230 170 233
6/25/2019 16:33:00 5.0 5.0 -56.9 -60.0 200 200 230 170 234
6/25/2019 16:34:00 5.0 5.0 -57.0 -60.1 199 200 230 170 234
6/25/2019 16:35:00 5.0 5.0 -56.9 -60.2 200 200 230 170 234
6/25/2019 16:36:00 5.0 5.0 -57.0 -60.3 200 200 230 170 234
6/25/2019 16:37:00 5.0 5.0 -57.0 -60.4 200 200 230 170 234
6/25/2019 16:38:00 5.0 5.0 -57.1 -60.4 200 200 230 170 234
6/25/2019 16:39:00 5.0 5.0 -57.1 -60.5 200 200 230 170 234
6/25/2019 16:40:00 5.0 5.0 -57.1 -60.5 200 200 230 170 233
6/25/2019 16:41:00 5.0 5.0 -57.1 -60.5 200 200 230 170 234
6/25/2019 16:42:00 5.0 5.0 -57.1 -60.6 200 200 230 170 233
6/25/2019 16:43:00 5.0 5.0 -57.1 -60.7 200 200 230 170 233

-------------------------------------------
Approved by Date Page: 61 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 16:44:00 5.0 5.0 -57.0 -60.8 200 200 230 170 233
6/25/2019 16:45:00 5.0 5.0 -57.0 -60.8 200 200 230 170 232
6/25/2019 16:46:00 5.0 5.0 -56.8 -60.9 200 200 230 170 232
6/25/2019 16:47:00 5.0 5.0 -56.8 -61.0 200 200 230 170 229
6/25/2019 16:48:00 5.0 5.0 -56.8 -61.1 200 200 230 170 229
6/25/2019 16:49:00 5.0 5.0 -56.9 -61.2 200 200 230 170 229
6/25/2019 16:50:00 5.1 5.0 -56.9 -61.3 200 200 230 170 228
6/25/2019 16:51:00 5.1 5.0 -56.9 -61.5 200 200 230 170 228
6/25/2019 16:52:00 5.0 5.0 -56.8 -61.5 200 200 230 170 228
6/25/2019 16:53:00 5.0 5.0 -56.9 -61.6 200 200 230 170 226
6/25/2019 16:54:00 5.0 5.0 -56.9 -61.6 200 200 230 170 226
6/25/2019 16:55:00 5.0 5.0 -56.9 -61.7 200 200 230 170 226
6/25/2019 16:56:00 4.9 5.0 -56.9 -61.9 202 200 230 170 225
6/25/2019 16:57:00 5.0 5.0 -57.0 -62.0 200 200 230 170 224
6/25/2019 16:58:00 5.0 5.0 -57.0 -62.1 202 200 230 170 224
6/25/2019 16:59:00 5.0 5.0 -57.0 -62.2 200 200 230 170 222
6/25/2019 17:00:00 5.0 5.0 -57.0 -62.3 200 200 230 170 222
6/25/2019 17:01:00 5.0 5.0 -57.1 -62.3 200 200 230 170 222
6/25/2019 17:02:00 5.0 5.0 -57.1 -62.5 200 200 230 170 221
6/25/2019 17:03:00 5.0 5.0 -57.1 -62.6 200 200 230 170 221
6/25/2019 17:04:00 5.0 5.0 -57.1 -62.6 200 200 230 170 220
6/25/2019 17:05:00 5.0 5.0 -57.1 -62.7 200 200 230 170 220
6/25/2019 17:06:00 5.1 5.0 -57.0 -62.8 200 200 230 170 220
6/25/2019 17:07:00 5.1 5.0 -57.1 -62.9 200 200 230 170 219
6/25/2019 17:08:00 5.0 5.0 -57.0 -63.0 200 200 230 170 217
6/25/2019 17:09:00 5.0 5.0 -57.0 -63.1 199 200 230 170 216
6/25/2019 17:10:00 5.0 5.0 -57.0 -63.3 200 200 230 170 216

-------------------------------------------
Approved by Date Page: 62 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 17:11:00 5.0 5.0 -56.9 -63.3 200 200 230 170 216
6/25/2019 17:12:00 5.0 5.0 -56.9 -63.4 200 200 230 170 215
6/25/2019 17:13:00 5.0 5.0 -56.9 -63.5 200 200 230 170 215
6/25/2019 17:14:00 5.0 5.0 -56.8 -63.6 200 200 230 170 214
6/25/2019 17:15:00 5.0 5.0 -56.8 -63.7 200 200 230 170 214
6/25/2019 17:16:00 5.0 5.0 -56.8 -63.9 200 200 230 170 212
6/25/2019 17:17:00 5.0 5.0 -56.9 -64.0 200 200 230 170 212
6/25/2019 17:18:00 5.0 5.0 -56.9 -64.1 200 200 230 170 211
6/25/2019 17:19:00 5.0 5.0 -56.9 -64.2 200 200 230 170 211
6/25/2019 17:20:00 5.0 5.0 -56.9 -64.3 200 200 230 170 211
6/25/2019 17:21:00 5.0 5.0 -56.8 -64.3 200 200 230 170 210
6/25/2019 17:22:00 5.0 5.0 -56.8 -64.5 200 200 230 170 210
6/25/2019 17:23:00 5.0 5.0 -56.9 -64.6 200 200 230 170 210
6/25/2019 17:24:00 5.1 5.0 -56.9 -64.7 200 200 230 170 209
6/25/2019 17:25:00 5.0 5.0 -56.8 -64.7 200 200 230 170 209
6/25/2019 17:26:00 5.0 5.0 -56.9 -64.8 200 200 230 170 207
6/25/2019 17:27:00 5.0 5.0 -56.8 -64.9 200 200 230 170 207
6/25/2019 17:28:00 5.0 5.0 -56.7 -65.0 200 200 230 170 207
6/25/2019 17:29:00 5.0 5.0 -56.7 -65.2 200 200 230 170 206
6/25/2019 17:30:00 4.9 5.0 -56.7 -65.3 199 200 230 170 206
6/25/2019 17:31:00 5.0 5.0 -56.7 -65.3 200 200 230 170 206
6/25/2019 17:32:00 5.0 5.0 -56.8 -65.4 200 200 230 170 206
6/25/2019 17:33:00 5.0 5.0 -56.8 -65.5 200 200 230 170 205
6/25/2019 17:34:00 5.0 5.0 -56.7 -65.5 200 200 230 170 205
6/25/2019 17:35:00 5.0 5.0 -56.8 -65.7 200 200 230 170 204
6/25/2019 17:36:00 5.0 5.0 -56.7 -65.8 200 200 230 170 204
6/25/2019 17:37:00 5.0 5.0 -56.8 -65.9 200 200 230 170 204

-------------------------------------------
Approved by Date Page: 63 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 17:38:00 5.1 5.0 -56.7 -66.0 199 200 230 170 204
6/25/2019 17:39:00 5.0 5.0 -56.7 -66.0 200 200 230 170 204
6/25/2019 17:40:00 5.0 5.0 -56.7 -66.1 200 200 230 170 204
6/25/2019 17:41:00 5.0 5.0 -56.6 -66.2 200 200 230 170 203
6/25/2019 17:42:00 5.0 5.0 -56.7 -66.4 200 200 230 170 203
6/25/2019 17:43:00 5.0 5.0 -56.6 -66.5 200 200 230 170 202
6/25/2019 17:44:00 5.1 5.0 -56.6 -66.6 200 200 230 170 203
6/25/2019 17:45:00 5.0 5.0 -56.7 -66.7 200 200 230 170 202
6/25/2019 17:46:00 5.0 5.0 -56.8 -66.7 200 200 230 170 201
6/25/2019 17:47:00 5.0 5.0 -56.9 -66.8 200 200 230 170 201
6/25/2019 17:48:00 5.0 5.0 -57.0 -66.9 200 200 230 170 202
6/25/2019 17:49:00 5.0 5.0 -57.0 -67.0 202 200 230 170 201
6/25/2019 17:50:00 5.0 5.0 -56.9 -67.1 200 200 230 170 200
6/25/2019 17:51:00 5.0 5.0 -56.9 -67.2 199 200 230 170 200
6/25/2019 17:52:00 5.0 5.0 -56.9 -67.3 202 200 230 170 200
6/25/2019 17:53:00 5.0 5.0 -57.0 -67.4 200 200 230 170 199
6/25/2019 17:54:00 5.0 5.0 -57.0 -67.5 200 200 230 170 200
6/25/2019 17:55:00 5.0 5.0 -57.0 -67.6 200 200 230 170 200
6/25/2019 17:56:00 5.0 5.0 -56.9 -67.7 200 200 230 170 199
6/25/2019 17:57:00 5.0 5.0 -57.1 -67.8 200 200 230 170 199
6/25/2019 17:58:00 5.0 5.0 -57.0 -67.9 200 200 230 170 199
6/25/2019 17:59:00 5.0 5.0 -57.0 -67.9 200 200 230 170 199
6/25/2019 18:00:00 5.0 5.0 -57.0 -68.0 202 200 230 170 199
6/25/2019 18:01:00 5.0 5.0 -57.0 -68.1 200 200 230 170 198
6/25/2019 18:02:00 5.1 5.0 -57.1 -68.2 200 200 230 170 198
6/25/2019 18:03:00 5.1 5.0 -57.0 -68.3 199 200 230 170 198
6/25/2019 18:04:00 5.0 5.0 -57.1 -68.4 200 200 230 170 198

-------------------------------------------
Approved by Date Page: 64 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 18:05:00 4.9 5.0 -57.1 -68.4 200 200 230 170 198
6/25/2019 18:06:00 4.9 5.0 -57.1 -68.5 200 200 230 170 197
6/25/2019 18:07:00 5.0 5.0 -57.0 -68.7 200 200 230 170 197
6/25/2019 18:08:00 5.0 5.0 -57.1 -68.7 199 200 230 170 197
6/25/2019 18:09:00 5.0 5.0 -56.9 -68.8 200 200 230 170 198
6/25/2019 18:10:00 5.0 5.0 -56.9 -68.9 200 200 230 170 197
6/25/2019 18:11:00 5.1 5.0 -57.0 -69.0 200 200 230 170 197
6/25/2019 18:12:00 5.1 5.0 -56.7 -69.0 200 200 230 170 197
6/25/2019 18:13:00 5.0 5.0 -57.0 -69.2 200 200 230 170 197
6/25/2019 18:14:00 5.0 5.0 -57.0 -69.3 200 200 230 170 197
6/25/2019 18:15:00 4.9 5.0 -57.0 -69.4 200 200 230 170 197
6/25/2019 18:16:00 4.9 5.0 -56.9 -69.4 202 200 230 170 197
6/25/2019 18:17:00 5.0 5.0 -57.0 -69.5 202 200 230 170 197
6/25/2019 18:18:00 5.0 5.0 -57.0 -69.6 202 200 230 170 197
6/25/2019 18:19:00 5.0 5.0 -57.1 -69.7 202 200 230 170 197
6/25/2019 18:20:00 5.0 5.0 -57.2 -69.8 202 200 230 170 196
6/25/2019 18:21:00 5.0 5.0 -57.0 -69.9 202 200 230 170 196
6/25/2019 18:22:00 5.0 5.0 -57.2 -69.9 202 200 230 170 196
6/25/2019 18:23:00 5.0 5.0 -57.1 -70.0 200 200 230 170 196
6/25/2019 18:24:00 5.0 5.0 -57.2 -70.0 200 200 230 170 196
6/25/2019 18:25:00 5.0 5.0 -57.1 -70.1 199 200 230 170 195
6/25/2019 18:26:00 5.0 5.0 -57.3 -70.2 200 200 230 170 195
6/25/2019 18:27:00 5.0 5.0 -57.2 -70.3 199 200 230 170 195
6/25/2019 18:28:00 5.0 5.0 -57.4 -70.4 200 200 230 170 195
6/25/2019 18:29:00 5.0 5.0 -57.1 -70.4 200 200 230 170 195
6/25/2019 18:30:00 5.0 5.0 -57.5 -70.5 200 200 230 170 195
6/25/2019 18:31:00 5.1 5.0 -57.4 -70.6 199 200 230 170 195

-------------------------------------------
Approved by Date Page: 65 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 18:32:00 5.0 5.0 -57.6 -70.6 199 200 230 170 195
6/25/2019 18:33:00 5.0 5.0 -57.4 -70.7 200 200 230 170 194
6/25/2019 18:34:00 5.0 5.0 -57.6 -70.8 200 200 230 170 195
6/25/2019 18:35:00 5.0 5.0 -57.7 -70.9 200 200 230 170 195
6/25/2019 18:36:00 5.0 5.0 -57.4 -70.9 200 200 230 170 195
6/25/2019 18:37:00 5.0 5.0 -57.7 -71.0 202 200 230 170 195
6/25/2019 18:38:00 5.0 5.0 -57.8 -71.1 202 200 230 170 195
6/25/2019 18:39:00 5.0 5.0 -57.7 -71.3 200 200 230 170 195
6/25/2019 18:40:00 5.0 5.0 -57.8 -71.4 200 200 230 170 195
6/25/2019 18:41:00 5.0 5.0 -57.7 -71.5 200 200 230 170 194
6/25/2019 18:42:00 5.0 5.0 -57.9 -71.5 200 200 230 170 194
6/25/2019 18:43:00 5.0 5.0 -58.1 -71.6 200 200 230 170 194
6/25/2019 18:44:00 5.1 5.0 -57.9 -71.8 199 200 230 170 194
6/25/2019 18:45:00 5.1 5.0 -58.1 -71.9 199 200 230 170 192
6/25/2019 18:46:00 5.0 5.0 -57.9 -72.0 199 200 230 170 192
6/25/2019 18:47:00 5.0 5.0 -57.3 -72.1 199 200 230 170 192
6/25/2019 18:48:00 5.0 5.0 -56.6 -72.2 199 200 230 170 192
6/25/2019 18:49:00 5.0 5.0 -56.1 -72.2 199 200 230 170 192
6/25/2019 18:50:00 5.0 5.0 -56.9 -72.3 200 200 230 170 192
6/25/2019 18:51:00 5.0 5.0 -57.3 -72.5 200 200 230 170 192
6/25/2019 18:52:00 5.0 5.0 -57.3 -72.5 200 200 230 170 192
6/25/2019 18:53:00 5.0 5.0 -56.9 -72.6 199 200 230 170 192
6/25/2019 18:54:00 5.0 5.0 -57.0 -72.7 198 200 230 170 192
6/25/2019 18:55:00 5.0 5.0 -57.4 -72.7 199 200 230 170 192
6/25/2019 18:56:00 5.1 5.0 -57.5 -72.8 199 200 230 170 191
6/25/2019 18:57:00 5.0 5.0 -57.3 -72.9 199 200 230 170 192
6/25/2019 18:58:00 5.0 5.0 -56.9 -73.0 200 200 230 170 194

-------------------------------------------
Approved by Date Page: 66 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 18:59:00 5.1 5.0 -57.5 -73.1 202 200 230 170 194
6/25/2019 19:00:00 5.0 5.0 -57.7 -73.1 202 200 230 170 194
6/25/2019 19:01:00 5.0 5.0 -57.5 -73.2 200 200 230 170 192
6/25/2019 19:02:00 5.0 5.0 -57.0 -73.3 199 200 230 170 191
6/25/2019 19:03:00 4.8 5.0 -57.1 -73.4 199 200 230 170 191
6/25/2019 19:04:00 4.8 5.0 -57.5 -73.5 200 200 230 170 192
6/25/2019 19:05:00 5.0 5.0 -57.3 -73.5 202 200 230 170 194
6/25/2019 19:06:00 5.0 5.0 -57.4 -73.6 200 200 230 170 192
6/25/2019 19:07:00 5.0 5.0 -57.1 -73.7 199 200 230 170 191
6/25/2019 19:08:00 5.0 5.0 -56.4 -73.7 200 200 230 170 194
6/25/2019 19:09:00 5.0 5.0 -55.9 -73.8 202 200 230 170 194
6/25/2019 19:10:00 5.1 5.0 -55.5 -73.9 198 200 230 170 191
6/25/2019 19:11:00 5.0 5.0 -55.8 -74.0 199 200 230 170 191
6/25/2019 19:12:00 5.0 5.0 -56.1 -74.0 202 200 230 170 194
6/25/2019 19:13:00 5.0 5.0 -56.0 -74.0 199 200 230 170 190
6/25/2019 19:14:00 5.1 5.0 -56.5 -74.1 202 200 230 170 194
6/25/2019 19:15:00 5.0 5.0 -56.8 -74.2 198 200 230 170 190
6/25/2019 19:16:00 5.0 5.0 -56.4 -74.2 200 200 230 170 192
6/25/2019 19:17:00 5.0 5.0 -56.0 -74.2 199 200 230 170 190
6/25/2019 19:18:00 5.0 5.0 -55.7 -74.3 199 200 230 170 190
6/25/2019 19:19:00 5.0 5.0 -55.4 -74.4 202 200 230 170 194
6/25/2019 19:20:00 4.8 5.0 -55.1 -74.4 199 200 230 170 190
6/25/2019 19:21:00 4.7 5.0 -54.9 -74.4 197 200 230 170 189
6/25/2019 19:22:00 4.7 5.0 -54.7 -74.5 204 200 230 170 196
6/25/2019 19:23:00 5.1 5.0 -54.5 -74.5 207 200 230 170 199
6/25/2019 19:24:00 5.0 5.0 -55.3 -74.6 198 200 230 170 189
6/25/2019 19:25:00 5.0 5.0 -55.9 -74.7 175 200 230 170 164

-------------------------------------------
Approved by Date Page: 67 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 19:26:00 5.0 5.0 -55.9 -74.7 219 200 230 170 212
6/25/2019 19:27:00 5.0 5.0 -56.2 -74.8 191 200 230 170 183
6/25/2019 19:28:00 4.8 5.0 -56.1 -74.8 202 200 230 170 193
6/25/2019 19:29:00 5.1 5.0 -55.8 -74.8 210 200 230 170 204
6/25/2019 19:30:00 5.1 5.0 -55.6 -74.9 180 200 230 170 169
6/25/2019 19:31:00 4.7 5.0 -55.3 -75.0 220 200 230 170 214
6/25/2019 19:32:00 5.0 5.0 -55.2 -75.0 172 200 230 170 162
6/25/2019 19:33:00 4.7 5.0 -56.3 -75.0 219 200 230 170 212
6/25/2019 19:34:00 5.0 5.0 -56.8 -75.1 179 200 230 170 169
6/25/2019 19:35:00 5.0 5.0 -56.4 -75.1 215 200 230 170 209
6/25/2019 19:36:00 5.0 5.0 -55.8 -75.1 186 200 230 170 178
6/25/2019 19:37:00 5.0 5.0 -55.3 -75.2 210 200 230 170 203
6/25/2019 19:38:00 5.0 5.0 -54.8 -75.2 194 200 230 170 186
6/25/2019 19:39:00 5.0 5.0 -54.4 -75.2 203 200 230 170 195
6/25/2019 19:40:00 5.0 5.0 -55.0 -75.3 197 200 230 170 189
6/25/2019 19:41:00 4.7 5.0 -55.7 -75.3 205 200 230 170 197
6/25/2019 19:42:00 4.7 5.0 -55.7 -75.4 197 200 230 170 188
6/25/2019 19:43:00 4.7 5.0 -56.1 -75.5 206 200 230 170 199
6/25/2019 19:44:00 4.7 5.0 -56.3 -75.5 192 200 230 170 183
6/25/2019 19:45:00 4.7 5.0 -56.6 -75.5 210 200 230 170 203
6/25/2019 19:46:00 4.7 5.0 -56.6 -75.6 190 200 230 170 180
6/25/2019 19:47:00 4.7 5.0 -56.1 -75.6 215 200 230 170 207
6/25/2019 19:48:00 4.7 5.0 -55.8 -75.6 177 200 230 170 166
6/25/2019 19:49:00 4.7 5.0 -55.4 -75.7 219 200 230 170 212
6/25/2019 19:50:00 4.7 5.0 -55.8 -75.7 170 200 230 170 158
6/25/2019 19:51:00 4.5 5.0 -56.5 -75.8 219 200 230 170 211
6/25/2019 19:52:00 4.7 5.0 -56.8 -75.8 181 200 230 170 169

-------------------------------------------
Approved by Date Page: 68 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 19:53:00 4.7 5.0 -56.9 -75.8 210 200 230 170 202
6/25/2019 19:54:00 4.7 5.0 -57.3 -75.9 196 200 230 170 185
6/25/2019 19:55:00 4.7 5.0 -57.2 -75.9 194 200 230 170 185
6/25/2019 19:56:00 4.7 5.0 -57.3 -76.0 213 200 230 170 205
6/25/2019 19:57:00 4.7 5.0 -57.2 -76.0 175 200 230 170 163
6/25/2019 19:58:00 4.7 5.0 -57.5 -76.1 219 200 230 170 211
6/25/2019 19:59:00 5.0 5.0 -57.3 -76.1 180 200 230 170 168
6/25/2019 20:00:00 5.0 5.0 -57.6 -76.2 208 200 230 170 199
6/25/2019 20:01:00 5.0 5.0 -57.7 -76.2 202 200 230 170 191
6/25/2019 20:02:00 5.0 5.0 -57.3 -76.3 185 200 230 170 175
6/25/2019 20:03:00 5.1 5.0 -56.8 -76.3 219 200 230 170 211
6/25/2019 20:04:00 5.1 5.0 -56.4 -76.3 172 200 230 170 160
6/25/2019 20:05:00 4.7 5.0 -56.0 -76.4 212 200 230 170 203
6/25/2019 20:06:00 4.7 5.0 -55.8 -76.4 204 200 230 170 193
6/25/2019 20:07:00 5.0 5.0 -56.6 -76.4 184 200 230 170 173
6/25/2019 20:08:00 5.0 5.0 -57.0 -76.5 219 200 230 170 210
6/25/2019 20:09:00 5.1 5.0 -57.2 -76.5 181 200 230 170 168
6/25/2019 20:10:00 5.1 5.0 -57.4 -76.6 203 200 230 170 193
6/25/2019 20:11:00 5.1 5.0 -57.2 -76.6 212 200 230 170 205
6/25/2019 20:12:00 4.7 5.0 -56.7 -76.7 170 200 230 170 157
6/25/2019 20:13:00 5.0 5.0 -56.3 -76.7 213 200 230 170 205
6/25/2019 20:14:00 5.0 5.0 -55.8 -76.7 202 200 230 170 192
6/25/2019 20:15:00 5.1 5.0 -55.4 -76.7 183 200 230 170 172
6/25/2019 20:16:00 4.8 5.0 -56.0 -76.8 219 200 230 170 210
6/25/2019 20:17:00 4.7 5.0 -56.4 -76.9 192 200 230 170 182
6/25/2019 20:18:00 5.0 5.0 -56.6 -76.9 189 200 230 170 179
6/25/2019 20:19:00 5.0 5.0 -56.9 -77.0 219 200 230 170 210

-------------------------------------------
Approved by Date Page: 69 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 20:20:00 4.7 5.0 -56.9 -76.9 184 200 230 170 172
6/25/2019 20:21:00 4.7 5.0 -57.0 -77.0 195 200 230 170 186
6/25/2019 20:22:00 4.7 5.0 -57.0 -77.0 217 200 230 170 208
6/25/2019 20:23:00 5.1 5.0 -56.6 -77.0 178 200 230 170 164
6/25/2019 20:24:00 5.1 5.0 -56.0 -77.0 198 200 230 170 188
6/25/2019 20:25:00 4.7 5.0 -55.5 -77.1 217 200 230 170 210
6/25/2019 20:26:00 4.7 5.0 -55.0 -77.2 182 200 230 170 170
6/25/2019 20:27:00 5.0 5.0 -55.4 -77.2 197 200 230 170 187
6/25/2019 20:28:00 5.1 5.0 -56.0 -77.2 217 200 230 170 210
6/25/2019 20:29:00 4.7 5.0 -56.4 -77.2 185 200 230 170 173
6/25/2019 20:30:00 5.1 5.0 -56.6 -77.2 194 200 230 170 185
6/25/2019 20:31:00 5.0 5.0 -56.9 -77.2 219 200 230 170 210
6/25/2019 20:32:00 4.7 5.0 -56.9 -77.3 192 200 230 170 183
6/25/2019 20:33:00 4.7 5.0 -56.4 -77.3 185 200 230 170 173
6/25/2019 20:34:00 5.0 5.0 -55.9 -77.3 218 200 230 170 209
6/25/2019 20:35:00 5.1 5.0 -55.3 -77.3 201 200 230 170 192
6/25/2019 20:36:00 4.8 5.0 -55.0 -77.4 175 200 230 170 163
6/25/2019 20:37:00 4.7 5.0 -55.7 -77.4 214 200 230 170 206
6/25/2019 20:38:00 5.1 5.0 -56.2 -77.4 210 200 230 170 203
6/25/2019 20:39:00 4.7 5.0 -56.6 -77.4 173 200 230 170 161
6/25/2019 20:40:00 5.0 5.0 -56.4 -77.4 199 200 230 170 190
6/25/2019 20:41:00 5.1 5.0 -56.6 -77.4 217 200 230 170 210
6/25/2019 20:42:00 4.7 5.0 -56.9 -77.5 192 200 230 170 182
6/25/2019 20:43:00 4.8 5.0 -56.9 -77.5 182 200 230 170 170
6/25/2019 20:44:00 5.1 5.0 -56.4 -77.5 217 200 230 170 209
6/25/2019 20:45:00 4.7 5.0 -55.8 -77.5 206 200 230 170 198
6/25/2019 20:46:00 5.0 5.0 -55.1 -77.5 172 200 230 170 159

-------------------------------------------
Approved by Date Page: 70 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 20:47:00 5.0 5.0 -55.5 -77.5 203 200 230 170 195
6/25/2019 20:48:00 4.7 5.0 -56.0 -77.5 215 200 230 170 207
6/25/2019 20:49:00 4.7 5.0 -56.1 -77.5 190 200 230 170 179
6/25/2019 20:50:00 5.1 5.0 -55.6 -77.6 183 200 230 170 172
6/25/2019 20:51:00 4.7 5.0 -55.0 -77.6 215 200 230 170 206
6/25/2019 20:52:00 5.0 5.0 -54.5 -77.6 205 200 230 170 197
6/25/2019 20:53:00 5.0 5.0 -55.3 -77.6 174 200 230 170 162
6/25/2019 20:54:00 4.7 5.0 -55.9 -77.6 197 200 230 170 188
6/25/2019 20:55:00 5.1 5.0 -56.3 -77.6 217 200 230 170 208
6/25/2019 20:56:00 5.1 5.0 -56.6 -77.6 201 200 230 170 192
6/25/2019 20:57:00 4.7 5.0 -56.3 -77.6 172 200 230 170 160
6/25/2019 20:58:00 5.1 5.0 -55.6 -77.7 204 200 230 170 195
6/25/2019 20:59:00 4.7 5.0 -55.0 -77.7 214 200 230 170 206
6/25/2019 21:00:00 5.1 5.0 -55.2 -77.7 193 200 230 170 184
6/25/2019 21:01:00 5.1 5.0 -55.9 -77.7 179 200 230 170 167
6/25/2019 21:02:00 4.7 5.0 -56.2 -77.7 211 200 230 170 203
6/25/2019 21:03:00 5.1 5.0 -56.3 -77.8 212 200 230 170 204
6/25/2019 21:04:00 4.7 5.0 -56.3 -77.8 187 200 230 170 176
6/25/2019 21:05:00 5.1 5.0 -56.3 -77.8 185 200 230 170 173
6/25/2019 21:06:00 5.1 5.0 -56.4 -77.8 215 200 230 170 206
6/25/2019 21:07:00 4.8 5.0 -56.7 -77.8 210 200 230 170 201
6/25/2019 21:08:00 5.1 5.0 -56.6 -77.8 185 200 230 170 172
6/25/2019 21:09:00 4.7 5.0 -56.1 -77.8 188 200 230 170 177
6/25/2019 21:10:00 5.1 5.0 -55.4 -77.8 214 200 230 170 206
6/25/2019 21:11:00 4.7 5.0 -55.2 -77.8 207 200 230 170 199
6/25/2019 21:12:00 5.0 5.0 -55.6 -77.9 179 200 230 170 168
6/25/2019 21:13:00 4.7 5.0 -55.1 -77.9 192 200 230 170 182

-------------------------------------------
Approved by Date Page: 71 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 21:14:00 4.7 5.0 -54.9 -77.9 217 200 230 170 207
6/25/2019 21:15:00 5.1 5.0 -55.4 -77.9 205 200 230 170 197
6/25/2019 21:16:00 4.7 5.0 -55.7 -77.9 179 200 230 170 166
6/25/2019 21:17:00 5.1 5.0 -55.8 -77.9 194 200 230 170 184
6/25/2019 21:18:00 4.7 5.0 -55.8 -78.0 217 200 230 170 206
6/25/2019 21:19:00 5.1 5.0 -55.7 -78.0 205 200 230 170 196
6/25/2019 21:20:00 4.7 5.0 -55.9 -78.0 179 200 230 170 165
6/25/2019 21:21:00 5.1 5.0 -55.8 -78.0 197 200 230 170 187
6/25/2019 21:22:00 4.7 5.0 -55.7 -78.0 217 200 230 170 206
6/25/2019 21:23:00 5.1 5.0 -55.8 -78.0 205 200 230 170 196
6/25/2019 21:24:00 4.8 5.0 -55.8 -78.1 179 200 230 170 167
6/25/2019 21:25:00 5.1 5.0 -55.7 -78.1 193 200 230 170 183
6/25/2019 21:26:00 4.7 5.0 -55.5 -78.1 215 200 230 170 206
6/25/2019 21:27:00 5.1 5.0 -55.5 -78.1 206 200 230 170 197
6/25/2019 21:28:00 4.7 5.0 -55.8 -78.1 180 200 230 170 168
6/25/2019 21:29:00 5.1 5.0 -55.8 -78.1 190 200 230 170 178
6/25/2019 21:30:00 5.1 5.0 -55.9 -78.1 214 200 230 170 205
6/25/2019 21:31:00 4.7 5.0 -55.4 -78.1 209 200 230 170 200
6/25/2019 21:32:00 5.1 5.0 -55.7 -78.1 185 200 230 170 175
6/25/2019 21:33:00 4.8 5.0 -55.7 -78.2 186 200 230 170 176
6/25/2019 21:34:00 5.1 5.0 -55.7 -78.2 212 200 230 170 204
6/25/2019 21:35:00 4.7 5.0 -55.6 -78.2 208 200 230 170 199
6/25/2019 21:36:00 5.1 5.0 -55.6 -78.2 189 200 230 170 177
6/25/2019 21:37:00 4.8 5.0 -55.5 -78.2 185 200 230 170 174
6/25/2019 21:38:00 5.1 5.0 -54.8 -78.2 212 200 230 170 202
6/25/2019 21:39:00 4.7 5.0 -54.1 -78.2 210 200 230 170 201
6/25/2019 21:40:00 5.1 5.0 -54.8 -78.2 189 200 230 170 177

-------------------------------------------
Approved by Date Page: 72 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 21:41:00 5.1 5.0 -54.5 -78.3 187 200 230 170 175
6/25/2019 21:42:00 4.8 5.0 -53.9 -78.2 212 200 230 170 203
6/25/2019 21:43:00 5.1 5.0 -54.3 -78.3 208 200 230 170 199
6/25/2019 21:44:00 4.7 5.0 -54.4 -78.3 189 200 230 170 178
6/25/2019 21:45:00 5.1 5.0 -53.8 -78.3 185 200 230 170 175
6/25/2019 21:46:00 4.7 5.0 -53.7 -78.3 212 200 230 170 202
6/25/2019 21:47:00 5.1 5.0 -54.2 -78.3 209 200 230 170 200
6/25/2019 21:48:00 4.7 5.0 -53.7 -78.3 189 200 230 170 177
6/25/2019 21:49:00 5.1 5.0 -53.1 -78.3 187 200 230 170 175
6/25/2019 21:50:00 4.7 5.0 -53.9 -78.3 213 200 230 170 204
6/25/2019 21:51:00 5.1 5.0 -53.6 -78.3 210 200 230 170 200
6/25/2019 21:52:00 4.7 5.0 -53.1 -78.3 190 200 230 170 179
6/25/2019 21:53:00 5.1 5.0 -53.6 -78.3 185 200 230 170 174
6/25/2019 21:54:00 4.8 5.0 -54.2 -78.3 210 200 230 170 201
6/25/2019 21:55:00 5.1 5.0 -54.5 -78.3 212 200 230 170 201
6/25/2019 21:56:00 4.8 5.0 -54.8 -78.3 192 200 230 170 182
6/25/2019 21:57:00 5.1 5.0 -55.0 -78.3 185 200 230 170 173
6/25/2019 21:58:00 4.8 5.0 -55.0 -78.3 208 200 230 170 198
6/25/2019 21:59:00 5.1 5.0 -55.2 -78.3 212 200 230 170 204
6/25/2019 22:00:00 4.8 5.0 -54.9 -78.4 195 200 230 170 185
6/25/2019 22:01:00 5.1 5.0 -54.3 -78.3 183 200 230 170 170
6/25/2019 22:02:00 4.5 5.0 -53.6 -78.4 205 200 230 170 196
6/25/2019 22:03:00 5.1 5.0 -54.2 -78.4 214 200 230 170 205
6/25/2019 22:04:00 4.7 5.0 -54.1 -78.4 197 200 230 170 187
6/25/2019 22:05:00 5.1 5.0 -53.5 -78.4 184 200 230 170 171
6/25/2019 22:06:00 4.5 5.0 -53.7 -78.4 200 200 230 170 190
6/25/2019 22:07:00 5.1 5.0 -54.0 -78.4 214 200 230 170 205

-------------------------------------------
Approved by Date Page: 73 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 22:08:00 4.8 5.0 -53.5 -78.4 202 200 230 170 191
6/25/2019 22:09:00 5.1 5.0 -53.1 -78.4 185 200 230 170 172
6/25/2019 22:10:00 4.8 5.0 -53.8 -78.4 197 200 230 170 187
6/25/2019 22:11:00 5.1 5.0 -53.5 -78.4 214 200 230 170 205
6/25/2019 22:12:00 4.7 5.0 -52.9 -78.4 204 200 230 170 193
6/25/2019 22:13:00 5.1 5.0 -53.6 -78.4 186 200 230 170 175
6/25/2019 22:14:00 4.7 5.0 -53.4 -78.4 192 200 230 170 183
6/25/2019 22:15:00 5.1 5.0 -52.9 -78.4 214 200 230 170 204
6/25/2019 22:16:00 4.5 5.0 -53.1 -78.4 205 200 230 170 197
6/25/2019 22:17:00 5.1 5.0 -53.4 -78.4 189 200 230 170 177
6/25/2019 22:18:00 4.7 5.0 -52.9 -78.4 192 200 230 170 182
6/25/2019 22:19:00 5.1 5.0 -53.1 -78.4 214 200 230 170 204
6/25/2019 22:20:00 4.8 5.0 -53.8 -78.4 205 200 230 170 196
6/25/2019 22:21:00 5.1 5.0 -54.2 -78.5 187 200 230 170 176
6/25/2019 22:22:00 4.7 5.0 -54.5 -78.5 197 200 230 170 186
6/25/2019 22:23:00 5.1 5.0 -54.4 -78.5 214 200 230 170 204
6/25/2019 22:24:00 4.5 5.0 -54.8 -78.5 204 200 230 170 193
6/25/2019 22:25:00 5.1 5.0 -54.8 -78.5 187 200 230 170 176
6/25/2019 22:26:00 4.7 5.0 -54.7 -78.5 199 200 230 170 189
6/25/2019 22:27:00 5.1 5.0 -54.5 -78.5 212 200 230 170 201
6/25/2019 22:28:00 4.8 5.0 -54.5 -78.6 199 200 230 170 190
6/25/2019 22:29:00 5.1 5.0 -54.1 -78.6 190 200 230 170 179
6/25/2019 22:30:00 4.7 5.0 -53.6 -78.6 198 200 230 170 188
6/25/2019 22:31:00 5.1 5.0 -54.1 -78.6 208 200 230 170 198
6/25/2019 22:32:00 4.7 5.0 -54.2 -78.6 202 200 230 170 192
6/25/2019 22:33:00 5.1 5.0 -54.2 -78.6 194 200 230 170 184
6/25/2019 22:34:00 4.7 5.0 -54.2 -78.6 197 200 230 170 186

-------------------------------------------
Approved by Date Page: 74 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 22:35:00 4.8 5.0 -54.4 -78.6 204 200 230 170 192
6/25/2019 22:36:00 5.1 5.0 -54.4 -78.6 203 200 230 170 192
6/25/2019 22:37:00 4.7 5.0 -54.3 -78.6 200 200 230 170 190
6/25/2019 22:38:00 5.1 5.0 -54.3 -78.6 199 200 230 170 189
6/25/2019 22:39:00 4.8 5.0 -54.4 -78.6 199 200 230 170 189
6/25/2019 22:40:00 5.1 5.0 -54.5 -78.6 199 200 230 170 189
6/25/2019 22:41:00 4.5 5.0 -54.5 -78.7 200 200 230 170 189
6/25/2019 22:42:00 5.1 5.0 -54.3 -78.7 200 200 230 170 189
6/25/2019 22:43:00 4.8 5.0 -54.4 -78.7 200 200 230 170 189
6/25/2019 22:44:00 5.1 5.0 -54.5 -78.7 200 200 230 170 189
6/25/2019 22:45:00 4.7 5.0 -54.0 -78.7 200 200 230 170 190
6/25/2019 22:46:00 5.1 5.0 -53.4 -78.7 200 200 230 170 189
6/25/2019 22:47:00 4.7 5.0 -53.5 -78.7 200 200 230 170 190
6/25/2019 22:48:00 5.1 5.0 -54.1 -78.7 200 200 230 170 189
6/25/2019 22:49:00 4.5 5.0 -54.3 -78.8 200 200 230 170 190
6/25/2019 22:50:00 5.1 5.0 -54.2 -78.8 200 200 230 170 190
6/25/2019 22:51:00 4.5 5.0 -54.5 -78.8 200 200 230 170 189
6/25/2019 22:52:00 5.1 5.0 -54.4 -78.8 200 200 230 170 190
6/25/2019 22:53:00 4.8 5.0 -54.4 -78.8 200 200 230 170 189
6/25/2019 22:54:00 5.1 5.0 -54.5 -78.8 200 200 230 170 190
6/25/2019 22:55:00 4.8 5.0 -54.4 -78.8 200 200 230 170 190
6/25/2019 22:56:00 5.1 5.0 -54.4 -78.8 200 200 230 170 190
6/25/2019 22:57:00 4.8 5.0 -54.4 -78.8 200 200 230 170 190
6/25/2019 22:58:00 5.1 5.0 -54.4 -78.8 200 200 230 170 190
6/25/2019 22:59:00 4.5 5.0 -54.6 -78.8 200 200 230 170 190
6/25/2019 23:00:00 5.1 5.0 -54.3 -78.8 200 200 230 170 190
6/25/2019 23:01:00 4.5 5.0 -53.8 -78.8 200 200 230 170 190

-------------------------------------------
Approved by Date Page: 75 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 23:02:00 5.1 5.0 -54.2 -78.8 200 200 230 170 190
6/25/2019 23:03:00 4.7 5.0 -54.6 -78.8 200 200 230 170 190
6/25/2019 23:04:00 5.1 5.0 -54.6 -78.8 199 200 230 170 190
6/25/2019 23:05:00 4.7 5.0 -54.5 -78.8 200 200 230 170 190
6/25/2019 23:06:00 5.1 5.0 -54.7 -78.8 200 200 230 170 190
6/25/2019 23:06:29 Audit: - Trend.grpDuration.strDuration.CurrentValue set to 24 by IDIN.
6/25/2019 23:07:00 4.8 5.0 -54.3 -78.8 200 200 230 170 190
6/25/2019 23:08:00 5.1 5.0 -54.6 -78.8 200 200 230 170 190
6/25/2019 23:09:00 4.8 5.0 -54.7 -78.8 200 200 230 170 190
6/25/2019 23:10:00 5.1 5.0 -54.8 -78.8 200 200 230 170 190
6/25/2019 23:11:00 4.8 5.0 -54.8 -78.9 200 200 230 170 190
6/25/2019 23:12:00 5.1 5.0 -54.8 -78.9 200 200 230 170 190
6/25/2019 23:13:00 4.5 5.0 -54.9 -78.9 200 200 230 170 190
6/25/2019 23:14:00 5.1 5.0 -54.9 -78.9 200 200 230 170 190
6/25/2019 23:15:00 4.5 5.0 -55.0 -78.9 200 200 230 170 190
6/25/2019 23:16:00 5.1 5.0 -54.8 -79.0 200 200 230 170 190
6/25/2019 23:17:00 4.5 5.0 -55.1 -79.0 200 200 230 170 190
6/25/2019 23:18:00 5.1 5.0 -54.7 -79.0 200 200 230 170 190
6/25/2019 23:19:00 4.8 5.0 -54.9 -79.0 200 200 230 170 190
6/25/2019 23:20:00 4.8 5.0 -54.8 -79.0 200 200 230 170 190
6/25/2019 23:21:00 5.1 5.0 -55.1 -79.0 200 200 230 170 190
6/25/2019 23:22:00 4.5 5.0 -55.1 -79.1 200 200 230 170 190
6/25/2019 23:23:00 5.1 5.0 -55.1 -79.1 200 200 230 170 190
6/25/2019 23:24:00 4.7 5.0 -55.2 -79.1 200 200 230 170 190
6/25/2019 23:25:00 5.1 5.0 -55.2 -79.1 200 200 230 170 190
6/25/2019 23:26:00 4.7 5.0 -54.9 -79.1 200 200 230 170 190
6/25/2019 23:27:00 4.7 5.0 -55.1 -79.1 200 200 230 170 190

-------------------------------------------
Approved by Date Page: 76 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 23:28:00 5.1 5.0 -55.1 -79.2 200 200 230 170 190
6/25/2019 23:29:00 4.5 5.0 -55.4 -79.2 200 200 230 170 190
6/25/2019 23:30:00 5.1 5.0 -55.4 -79.2 200 200 230 170 190
6/25/2019 23:31:00 4.7 5.0 -55.6 -79.2 200 200 230 170 190
6/25/2019 23:32:00 4.5 5.0 -55.3 -79.2 200 200 230 170 190
6/25/2019 23:33:00 5.1 5.0 -55.3 -79.3 200 200 230 170 190
6/25/2019 23:34:00 4.7 5.0 -55.3 -79.3 200 200 230 170 190
6/25/2019 23:35:00 5.1 5.0 -55.4 -79.3 200 200 230 170 190
6/25/2019 23:36:00 5.1 5.0 -55.3 -79.4 200 200 230 170 190
6/25/2019 23:37:00 4.8 5.0 -55.5 -79.4 200 200 230 170 190
6/25/2019 23:38:00 5.1 5.0 -55.6 -79.4 200 200 230 170 190
6/25/2019 23:39:00 4.8 5.0 -55.2 -79.4 200 200 230 170 190
6/25/2019 23:40:00 4.7 5.0 -55.2 -79.4 200 200 230 170 190
6/25/2019 23:41:00 5.1 5.0 -55.4 -79.4 200 200 230 170 190
6/25/2019 23:42:00 4.8 5.0 -55.5 -79.4 200 200 230 170 190
6/25/2019 23:43:00 5.1 5.0 -55.5 -79.4 200 200 230 170 190
6/25/2019 23:44:00 4.8 5.0 -55.4 -79.5 200 200 230 170 190
6/25/2019 23:45:00 5.1 5.0 -55.5 -79.5 200 200 230 170 190
6/25/2019 23:46:00 4.5 5.0 -55.7 -79.5 200 200 230 170 190
6/25/2019 23:47:00 4.7 5.0 -55.5 -79.5 200 200 230 170 190
6/25/2019 23:48:00 5.1 5.0 -55.5 -79.5 200 200 230 170 190
6/25/2019 23:49:00 4.5 5.0 -55.8 -79.5 200 200 230 170 190
6/25/2019 23:50:00 5.1 5.0 -55.8 -79.5 200 200 230 170 190
6/25/2019 23:51:00 4.5 5.0 -55.9 -79.5 200 200 230 170 190
6/25/2019 23:52:00 5.1 5.0 -55.8 -79.5 200 200 230 170 190
6/25/2019 23:53:00 5.1 5.0 -55.7 -79.5 200 200 230 170 190
6/25/2019 23:54:00 4.5 5.0 -55.9 -79.5 200 200 230 170 190

-------------------------------------------
Approved by Date Page: 77 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/25/2019 23:55:00 5.1 5.0 -55.8 -79.5 200 200 230 170 190
6/25/2019 23:56:00 4.8 5.0 -55.9 -79.6 200 200 230 170 190
6/25/2019 23:57:00 4.7 5.0 -56.1 -79.5 200 200 230 170 190
6/25/2019 23:58:00 5.1 5.0 -55.8 -79.5 200 200 230 170 190
6/25/2019 23:59:00 4.8 5.0 -55.9 -79.5 200 200 230 170 190
6/26/2019 00:00:00 5.1 5.0 -55.9 -79.6 200 200 230 170 190
6/26/2019 00:01:00 4.8 5.0 -55.9 -79.6 200 200 230 170 190
6/26/2019 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.
6/26/2019 00:02:00 5.1 5.0 -55.8 -79.6 200 200 230 170 190
6/26/2019 00:03:00 4.8 5.0 -56.0 -79.6 200 200 230 170 190
6/26/2019 00:04:00 5.1 5.0 -56.0 -79.6 200 200 230 170 190
6/26/2019 00:05:00 4.5 5.0 -56.0 -79.6 200 200 230 170 190
6/26/2019 00:05:30 Event: - Step advanced to [9] Drying
6/26/2019 00:06:00 5.1 5.2 -55.9 -79.6 200 200 230 170 190
6/26/2019 00:07:00 5.2 5.8 -56.4 -79.7 200 200 230 170 190
6/26/2019 00:08:00 5.6 6.2 -57.2 -79.7 200 200 230 170 190
6/26/2019 00:09:00 6.2 6.7 -58.0 -79.7 200 200 230 170 190
6/26/2019 00:10:00 7.0 7.2 -58.4 -79.7 200 200 230 170 190
6/26/2019 00:11:00 7.7 7.7 -58.4 -79.7 200 200 230 170 190
6/26/2019 00:12:00 8.4 8.2 -58.5 -79.7 200 200 230 170 190
6/26/2019 00:13:00 9.0 8.8 -58.7 -79.7 200 200 230 170 190
6/26/2019 00:14:00 9.4 9.2 -58.8 -79.8 200 200 230 170 190
6/26/2019 00:15:00 9.8 9.8 -58.8 -79.8 200 200 230 170 190
6/26/2019 00:16:00 10.2 10.2 -58.7 -79.8 200 200 230 170 190
6/26/2019 00:17:00 10.6 10.7 -58.6 -79.8 200 200 230 170 190
6/26/2019 00:18:00 11.1 11.2 -58.6 -79.8 200 200 230 170 190

-------------------------------------------
Approved by Date Page: 78 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/26/2019 00:19:00 11.6 11.7 -58.7 -79.8 200 200 230 170 190
6/26/2019 00:20:00 12.1 12.2 -58.5 -79.8 200 200 230 170 190
6/26/2019 00:21:00 12.7 12.8 -58.6 -79.8 200 200 230 170 190
6/26/2019 00:22:00 13.3 13.2 -58.5 -79.8 200 200 230 170 190
6/26/2019 00:23:00 13.8 13.7 -58.5 -79.8 200 200 230 170 190
6/26/2019 00:24:00 14.3 14.2 -58.4 -79.9 200 200 230 170 190
6/26/2019 00:25:00 14.8 14.7 -58.3 -79.8 200 200 230 170 190
6/26/2019 00:26:00 15.2 15.2 -58.4 -79.8 200 200 230 170 190
6/26/2019 00:27:00 15.7 15.8 -58.5 -79.9 200 200 230 170 190
6/26/2019 00:28:00 16.2 16.2 -58.4 -79.9 200 200 230 170 190
6/26/2019 00:29:00 16.7 16.8 -58.4 -79.9 200 200 230 170 190
6/26/2019 00:30:00 17.2 17.2 -57.9 -79.9 200 200 230 170 190
6/26/2019 00:31:00 17.7 17.7 -58.0 -79.9 200 200 230 170 190
6/26/2019 00:32:00 18.2 18.2 -58.5 -79.9 200 200 230 170 190
6/26/2019 00:33:00 18.7 18.7 -58.7 -79.9 200 200 230 170 190
6/26/2019 00:34:00 19.2 19.2 -58.8 -79.9 200 200 230 170 190
6/26/2019 00:35:00 19.7 19.8 -58.7 -79.9 200 200 230 170 190
6/26/2019 00:36:00 20.2 20.2 -58.5 -79.9 200 200 230 170 190
6/26/2019 00:37:00 20.7 20.8 -58.3 -80.0 200 200 230 170 190
6/26/2019 00:38:00 21.2 21.2 -58.3 -79.9 200 200 230 170 190
6/26/2019 00:39:00 21.8 21.7 -58.2 -80.0 200 200 230 170 190
6/26/2019 00:40:00 22.2 22.2 -58.1 -80.0 200 200 230 170 190
6/26/2019 00:41:00 22.7 22.7 -58.0 -80.0 200 200 230 170 190
6/26/2019 00:42:00 23.2 23.2 -57.7 -80.0 200 200 230 170 190
6/26/2019 00:43:00 23.7 23.8 -57.8 -80.0 200 200 230 170 190
6/26/2019 00:44:00 24.2 24.2 -57.9 -80.0 200 200 230 170 190
6/26/2019 00:45:00 24.7 24.7 -57.8 -80.0 200 200 230 170 190

-------------------------------------------
Approved by Date Page: 79 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/26/2019 00:46:00 25.2 25.2 -57.8 -80.0 200 200 230 170 190
6/26/2019 00:47:00 25.7 25.7 -57.9 -80.0 200 200 230 170 190
6/26/2019 00:48:00 26.2 26.2 -57.9 -80.0 200 200 230 170 190
6/26/2019 00:49:00 26.7 26.8 -58.0 -80.0 200 200 230 170 190
6/26/2019 00:50:00 27.2 27.2 -57.7 -80.0 200 200 230 170 190
6/26/2019 00:51:00 27.8 27.8 -57.7 -80.0 200 200 230 170 190
6/26/2019 00:52:00 28.3 28.2 -57.8 -80.0 200 200 230 170 190
6/26/2019 00:53:00 28.7 28.7 -57.7 -80.0 200 200 230 170 190
6/26/2019 00:54:00 29.2 29.2 -57.8 -80.0 200 200 230 170 190
6/26/2019 00:55:00 29.7 29.7 -57.6 -80.0 200 200 230 170 190
6/26/2019 00:56:00 30.1 30.2 -57.7 -80.0 200 200 230 170 190
6/26/2019 00:57:00 30.7 30.8 -57.4 -80.0 200 200 230 170 190
6/26/2019 00:58:00 31.2 31.2 -56.6 -80.0 200 200 230 170 190
6/26/2019 00:59:00 31.7 31.8 -56.9 -80.0 200 200 230 170 190
6/26/2019 01:00:00 32.3 32.2 -57.4 -80.0 200 200 230 170 190
6/26/2019 01:01:00 32.8 32.7 -57.6 -80.0 200 200 230 170 190
6/26/2019 01:02:00 33.3 33.2 -57.6 -80.0 200 200 230 170 190
6/26/2019 01:03:00 33.8 33.7 -57.6 -80.0 200 200 230 170 190
6/26/2019 01:04:00 34.3 34.2 -57.5 -80.0 200 200 230 170 190
6/26/2019 01:05:00 34.7 34.8 -57.4 -80.0 200 200 230 170 190
6/26/2019 01:06:00 35.2 35.2 -57.4 -80.0 200 200 230 170 190
6/26/2019 01:07:00 35.7 35.7 -57.4 -80.0 200 200 230 170 190
6/26/2019 01:08:00 36.2 36.2 -57.4 -80.1 200 200 230 170 190
6/26/2019 01:09:00 36.7 36.7 -57.5 -80.1 200 200 230 170 190
6/26/2019 01:10:00 37.2 37.2 -57.6 -80.1 200 200 230 170 190
6/26/2019 01:11:00 37.8 37.8 -57.5 -80.1 200 200 230 170 190
6/26/2019 01:12:00 38.3 38.2 -57.4 -80.1 200 200 230 170 190

-------------------------------------------
Approved by Date Page: 80 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/26/2019 01:13:00 38.8 38.8 -57.3 -80.1 200 200 230 170 190
6/26/2019 01:14:00 39.2 39.2 -57.1 -80.1 200 200 230 170 190
6/26/2019 01:15:00 39.7 39.7 -57.2 -80.1 200 200 230 170 190
6/26/2019 01:16:00 40.2 40.2 -57.2 -80.1 200 200 230 170 190
6/26/2019 01:17:00 40.7 40.7 -57.1 -80.0 200 200 230 170 190
6/26/2019 01:18:00 41.2 41.2 -57.1 -80.1 200 200 230 170 190
6/26/2019 01:19:00 41.7 41.8 -56.4 -80.0 200 200 230 170 190
6/26/2019 01:20:00 42.2 42.2 -56.1 -80.1 200 200 230 170 190
6/26/2019 01:21:00 42.7 42.7 -56.5 -80.1 200 200 230 170 190
6/26/2019 01:22:00 43.2 43.2 -56.6 -80.1 200 200 230 170 190
6/26/2019 01:23:00 43.8 43.7 -56.7 -80.1 200 200 230 170 190
6/26/2019 01:24:00 44.3 44.2 -56.8 -80.1 200 200 230 170 190
6/26/2019 01:25:00 44.7 44.8 -56.8 -80.1 200 200 230 170 190
6/26/2019 01:26:00 45.2 45.2 -56.8 -80.1 200 200 230 170 190
6/26/2019 01:27:00 45.7 45.8 -56.8 -80.1 200 200 230 170 190
6/26/2019 01:28:00 46.2 46.2 -56.8 -80.1 200 200 230 170 190
6/26/2019 01:29:00 46.7 46.7 -56.8 -80.0 200 200 230 170 190
6/26/2019 01:30:00 47.2 47.2 -56.7 -80.1 200 200 230 170 190
6/26/2019 01:31:00 47.7 47.7 -56.7 -80.1 200 200 230 170 190
6/26/2019 01:32:00 48.2 48.2 -56.7 -80.1 200 200 230 170 190
6/26/2019 01:33:00 48.7 48.8 -56.7 -80.1 200 200 230 170 190
6/26/2019 01:34:00 49.2 49.2 -56.6 -80.1 200 200 230 170 190
6/26/2019 01:35:00 49.7 49.7 -56.5 -80.1 200 200 230 170 190
6/26/2019 01:35:30 Event: - Step advanced to [10] Drying
6/26/2019 01:36:00 50.2 50.0 -56.3 -80.1 200 200 230 170 190
6/26/2019 01:37:00 50.6 50.0 -56.4 -80.1 200 200 230 170 190
6/26/2019 01:38:00 50.7 50.0 -56.5 -80.1 200 200 230 170 190

-------------------------------------------
Approved by Date Page: 81 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/26/2019 01:39:00 50.5 50.0 -56.6 -80.1 200 200 230 170 190
6/26/2019 01:40:00 50.3 50.0 -56.7 -80.0 200 200 230 170 190
6/26/2019 01:41:00 50.0 50.0 -56.5 -80.1 200 200 230 170 190
6/26/2019 01:42:00 49.9 50.0 -56.3 -80.1 200 200 230 170 190
6/26/2019 01:43:00 49.7 50.0 -56.4 -80.1 200 200 230 170 190
6/26/2019 01:44:00 49.8 50.0 -56.8 -80.1 200 200 230 170 190
6/26/2019 01:45:00 49.8 50.0 -57.0 -80.1 200 200 230 170 190
6/26/2019 01:46:00 50.0 50.0 -57.1 -80.1 200 200 230 170 190
6/26/2019 01:47:00 50.1 50.0 -57.1 -80.1 200 200 230 170 190
6/26/2019 01:48:00 50.2 50.0 -57.0 -80.1 200 200 230 170 190
6/26/2019 01:49:00 50.1 50.0 -56.4 -80.1 200 200 230 170 190
6/26/2019 01:50:00 50.1 50.0 -56.6 -80.1 200 200 230 170 190
6/26/2019 01:51:00 50.0 50.0 -56.7 -80.1 200 200 230 170 190
6/26/2019 01:52:00 49.9 50.0 -56.8 -80.1 200 200 230 170 190
6/26/2019 01:53:00 49.9 50.0 -56.9 -80.1 200 200 230 170 190
6/26/2019 01:54:00 49.9 50.0 -57.0 -80.1 200 200 230 170 190
6/26/2019 01:55:00 49.9 50.0 -57.0 -80.1 200 200 230 170 190
6/26/2019 01:56:00 50.0 50.0 -57.0 -80.1 200 200 230 170 190
6/26/2019 01:57:00 50.0 50.0 -57.0 -80.2 200 200 230 170 190
6/26/2019 01:58:00 50.1 50.0 -57.0 -80.2 200 200 230 170 190
6/26/2019 01:59:00 50.1 50.0 -56.8 -80.2 200 200 230 170 190
6/26/2019 02:00:00 50.1 50.0 -57.0 -80.2 200 200 230 170 190
6/26/2019 02:01:00 50.0 50.0 -57.1 -80.2 200 200 230 170 189
6/26/2019 02:02:00 50.0 50.0 -57.1 -80.2 200 200 230 170 190
6/26/2019 02:03:00 50.0 50.0 -57.2 -80.2 200 200 230 170 189
6/26/2019 02:04:00 49.9 50.0 -57.1 -80.2 200 200 230 170 190
6/26/2019 02:05:00 49.9 50.0 -57.0 -80.2 200 200 230 170 189

-------------------------------------------
Approved by Date Page: 82 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/26/2019 02:06:00 50.0 50.0 -57.1 -80.2 200 200 230 170 190
6/26/2019 02:07:00 50.0 50.0 -57.1 -80.2 200 200 230 170 190
6/26/2019 02:08:00 50.1 50.0 -56.4 -80.2 200 200 230 170 189
6/26/2019 02:09:00 50.0 50.0 -55.7 -80.2 200 200 230 170 190
6/26/2019 02:10:00 50.0 50.0 -56.4 -80.2 200 200 230 170 189
6/26/2019 02:11:00 50.0 50.0 -56.7 -80.2 200 200 230 170 190
6/26/2019 02:12:00 50.0 50.0 -56.8 -80.2 200 200 230 170 190
6/26/2019 02:13:00 50.0 50.0 -56.8 -80.2 200 200 230 170 189
6/26/2019 02:14:00 50.0 50.0 -56.8 -80.2 200 200 230 170 189
6/26/2019 02:15:00 50.0 50.0 -56.8 -80.2 200 200 230 170 189
6/26/2019 02:16:00 50.0 50.0 -56.8 -80.3 200 200 230 170 189
6/26/2019 02:17:00 50.0 50.0 -56.8 -80.2 200 200 230 170 189
6/26/2019 02:18:00 50.0 50.0 -56.9 -80.2 200 200 230 170 189
6/26/2019 02:19:00 50.0 50.0 -56.9 -80.3 200 200 230 170 190
6/26/2019 02:20:00 50.0 50.0 -56.9 -80.3 200 200 230 170 190
6/26/2019 02:21:00 50.0 50.0 -56.8 -80.3 200 200 230 170 190
6/26/2019 02:22:00 50.0 50.0 -56.8 -80.3 200 200 230 170 190
6/26/2019 02:23:00 50.0 50.0 -56.4 -80.3 200 200 230 170 190
6/26/2019 02:24:00 50.0 50.0 -56.4 -80.3 200 200 230 170 190
6/26/2019 02:25:00 50.0 50.0 -56.6 -80.3 200 200 230 170 190
6/26/2019 02:26:00 50.0 50.0 -56.6 -80.3 200 200 230 170 190
6/26/2019 02:27:00 50.0 50.0 -56.7 -80.3 200 200 230 170 190
6/26/2019 02:28:00 50.0 50.0 -56.8 -80.3 200 200 230 170 190
6/26/2019 02:29:00 50.0 50.0 -56.8 -80.3 200 200 230 170 190
6/26/2019 02:30:00 50.0 50.0 -56.8 -80.3 200 200 230 170 190
6/26/2019 02:31:00 50.0 50.0 -56.8 -80.4 200 200 230 170 190
6/26/2019 02:32:00 50.0 50.0 -56.8 -80.4 200 200 230 170 190

-------------------------------------------
Approved by Date Page: 83 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/26/2019 02:33:00 50.0 50.0 -56.8 -80.4 200 200 230 170 190
6/26/2019 02:34:00 50.1 50.0 -56.9 -80.3 200 200 230 170 190
6/26/2019 02:35:00 50.1 50.0 -56.8 -80.4 200 200 230 170 190
6/26/2019 02:36:00 50.0 50.0 -56.8 -80.3 200 200 230 170 190
6/26/2019 02:37:00 50.0 50.0 -56.6 -80.3 200 200 230 170 190
6/26/2019 02:38:00 49.9 50.0 -56.0 -80.4 200 200 230 170 190
6/26/2019 02:39:00 49.9 50.0 -56.3 -80.3 200 200 230 170 190
6/26/2019 02:40:00 50.0 50.0 -56.5 -80.3 200 200 230 170 190
6/26/2019 02:41:00 50.0 50.0 -56.6 -80.3 200 200 230 170 189
6/26/2019 02:42:00 50.0 50.0 -56.6 -80.4 200 200 230 170 189
6/26/2019 02:43:00 50.1 50.0 -56.8 -80.4 200 200 230 170 189
6/26/2019 02:44:00 50.1 50.0 -56.9 -80.4 200 200 230 170 189
6/26/2019 02:45:00 50.0 50.0 -57.0 -80.4 200 200 230 170 189
6/26/2019 02:46:00 50.0 50.0 -56.9 -80.4 200 200 230 170 189
6/26/2019 02:47:00 49.9 50.0 -56.9 -80.4 200 200 230 170 190
6/26/2019 02:48:00 50.0 50.0 -56.9 -80.4 200 200 230 170 189
6/26/2019 02:49:00 50.0 50.0 -56.9 -80.4 200 200 230 170 190
6/26/2019 02:50:00 50.0 50.0 -56.9 -80.4 200 200 230 170 189
6/26/2019 02:51:00 50.0 50.0 -56.9 -80.4 200 200 230 170 190
6/26/2019 02:52:00 50.0 50.0 -56.9 -80.4 200 200 230 170 189
6/26/2019 02:53:00 50.0 50.0 -56.9 -80.4 200 200 230 170 189
6/26/2019 02:54:00 50.0 50.0 -56.8 -80.4 200 200 230 170 189
6/26/2019 02:55:00 50.0 50.0 -56.6 -80.4 200 200 230 170 189
6/26/2019 02:56:00 50.0 50.0 -56.6 -80.4 200 200 230 170 189
6/26/2019 02:57:00 50.0 50.0 -56.8 -80.4 200 200 230 170 189
6/26/2019 02:58:00 50.0 50.0 -56.8 -80.4 200 200 230 170 189
6/26/2019 02:59:00 50.0 50.0 -56.9 -80.4 199 200 230 170 189

-------------------------------------------
Approved by Date Page: 84 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/26/2019 03:00:00 50.0 50.0 -56.8 -80.4 200 200 230 170 189
6/26/2019 03:01:00 50.0 50.0 -56.9 -80.4 200 200 230 170 189
6/26/2019 03:02:00 50.0 50.0 -56.9 -80.4 200 200 230 170 190
6/26/2019 03:03:00 50.0 50.0 -57.0 -80.4 200 200 230 170 189
6/26/2019 03:04:00 50.0 50.0 -56.9 -80.4 200 200 230 170 189
6/26/2019 03:05:00 50.0 50.0 -56.9 -80.4 200 200 230 170 189
6/26/2019 03:06:00 50.0 50.0 -57.0 -80.4 200 200 230 170 190
6/26/2019 03:07:00 50.0 50.0 -57.0 -80.5 200 200 230 170 189
6/26/2019 03:08:00 49.9 50.0 -57.0 -80.4 200 200 230 170 189
6/26/2019 03:09:00 50.0 50.0 -57.1 -80.4 200 200 230 170 189
6/26/2019 03:10:00 50.0 50.0 -57.0 -80.4 200 200 230 170 189
6/26/2019 03:11:00 50.0 50.0 -57.0 -80.4 200 200 230 170 190
6/26/2019 03:12:00 50.0 50.0 -57.1 -80.4 200 200 230 170 189
6/26/2019 03:13:00 50.0 50.0 -57.1 -80.4 200 200 230 170 190
6/26/2019 03:14:00 50.0 50.0 -57.1 -80.5 200 200 230 170 189
6/26/2019 03:15:00 50.0 50.0 -57.1 -80.5 200 200 230 170 189
6/26/2019 03:16:00 50.0 50.0 -57.1 -80.5 200 200 230 170 190
6/26/2019 03:17:00 50.0 50.0 -56.8 -80.5 200 200 230 170 189
6/26/2019 03:18:00 49.9 50.0 -57.0 -80.4 200 200 230 170 189
6/26/2019 03:19:00 50.0 50.0 -57.0 -80.5 200 200 230 170 189
6/26/2019 03:20:00 50.0 50.0 -57.1 -80.5 200 200 230 170 189
6/26/2019 03:21:00 50.1 50.0 -57.2 -80.5 200 200 230 170 189
6/26/2019 03:22:00 50.0 50.0 -57.1 -80.5 200 200 230 170 189
6/26/2019 03:23:00 50.0 50.0 -57.2 -80.5 200 200 230 170 189
6/26/2019 03:24:00 50.0 50.0 -57.3 -80.5 200 200 230 170 189
6/26/2019 03:25:00 50.0 50.0 -57.3 -80.5 200 200 230 170 189
6/26/2019 03:26:00 50.0 50.0 -57.3 -80.5 200 200 230 170 189

-------------------------------------------
Approved by Date Page: 85 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/26/2019 03:27:00 50.0 50.0 -57.3 -80.5 200 200 230 170 189
6/26/2019 03:28:00 50.0 50.0 -57.3 -80.5 200 200 230 170 189
6/26/2019 03:29:00 50.0 50.0 -57.4 -80.6 200 200 230 170 189
6/26/2019 03:30:00 50.0 50.0 -57.3 -80.5 200 200 230 170 189
6/26/2019 03:31:00 50.0 50.0 -57.4 -80.5 200 200 230 170 189
6/26/2019 03:32:00 50.0 50.0 -57.3 -80.5 200 200 230 170 189
6/26/2019 03:33:00 50.0 50.0 -57.4 -80.5 200 200 230 170 189
6/26/2019 03:34:00 50.0 50.0 -57.4 -80.5 200 200 230 170 189
6/26/2019 03:35:00 50.0 50.0 -57.4 -80.5 200 200 230 170 189
6/26/2019 03:36:00 50.0 50.0 -57.4 -80.5 200 200 230 170 189
6/26/2019 03:37:00 50.0 50.0 -57.4 -80.5 200 200 230 170 189
6/26/2019 03:38:00 50.0 50.0 -57.4 -80.6 200 200 230 170 189
6/26/2019 03:39:00 50.0 50.0 -57.4 -80.6 200 200 230 170 189
6/26/2019 03:40:00 50.0 50.0 -57.4 -80.6 200 200 230 170 189
6/26/2019 03:41:00 50.0 50.0 -57.5 -80.6 200 200 230 170 189
6/26/2019 03:42:00 50.0 50.0 -57.5 -80.6 200 200 230 170 189
6/26/2019 03:43:00 50.0 50.0 -57.5 -80.6 200 200 230 170 189
6/26/2019 03:44:00 50.0 50.0 -57.6 -80.5 200 200 230 170 189
6/26/2019 03:45:00 50.0 50.0 -57.5 -80.6 200 200 230 170 189
6/26/2019 03:46:00 50.0 50.0 -57.4 -80.6 200 200 230 170 189
6/26/2019 03:47:00 50.0 50.0 -57.4 -80.6 200 200 230 170 189
6/26/2019 03:48:00 50.0 50.0 -57.4 -80.6 200 200 230 170 189
6/26/2019 03:48:30 Alarm: CLOSE - COM2 motor over temperature.
6/26/2019 03:48:59 Audit: - A_COM2MOTORHT ALARM is acknowledged by IDIN.
6/26/2019 03:49:00 50.0 50.0 -56.8 -80.6 200 200 230 170 189
6/26/2019 03:49:01 Audit: - Alarm is reset manually by IDIN.
6/26/2019 03:50:00 50.0 50.0 -56.9 -80.6 200 200 230 170 189

-------------------------------------------
Approved by Date Page: 86 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/26/2019 03:51:00 50.0 50.0 -57.2 -80.6 200 200 230 170 189
6/26/2019 03:52:00 50.0 50.0 -57.5 -80.6 200 200 230 170 190
6/26/2019 03:53:00 50.0 50.0 -57.7 -80.6 200 200 230 170 189
6/26/2019 03:54:00 50.0 50.0 -58.1 -80.6 200 200 230 170 189
6/26/2019 03:55:00 50.0 50.0 -58.3 -80.7 200 200 230 170 189
6/26/2019 03:56:00 50.0 50.0 -58.5 -80.7 200 200 230 170 190
6/26/2019 03:57:00 50.0 50.0 -58.7 -80.6 200 200 230 170 189
6/26/2019 03:58:00 50.0 50.0 -58.9 -80.7 200 200 230 170 190
6/26/2019 03:59:00 50.0 50.0 -59.1 -80.7 200 200 230 170 189
6/26/2019 04:00:00 50.0 50.0 -59.3 -80.7 200 200 230 170 189
6/26/2019 04:01:00 50.0 50.0 -59.5 -80.7 200 200 230 170 190
6/26/2019 04:02:00 50.0 50.0 -59.7 -80.7 198 200 230 170 189
6/26/2019 04:03:00 50.0 50.0 -59.9 -80.7 200 200 230 170 190
6/26/2019 04:04:00 50.0 50.0 -60.0 -80.7 200 200 230 170 189
6/26/2019 04:05:00 50.1 50.0 -60.2 -80.7 200 200 230 170 190
6/26/2019 04:06:00 50.0 50.0 -60.4 -80.7 200 200 230 170 190
6/26/2019 04:07:00 50.0 50.0 -60.6 -80.7 200 200 230 170 189
6/26/2019 04:08:00 50.0 50.0 -60.8 -80.7 200 200 230 170 190
6/26/2019 04:09:00 50.0 50.0 -60.9 -80.8 200 200 230 170 189
6/26/2019 04:10:00 50.0 50.0 -61.0 -80.8 200 200 230 170 190
6/26/2019 04:11:00 50.0 50.0 -61.2 -80.8 200 200 230 170 189
6/26/2019 04:12:00 50.0 50.0 -61.3 -80.8 200 200 230 170 190
6/26/2019 04:13:00 50.0 50.0 -61.5 -80.8 200 200 230 170 189
6/26/2019 04:14:00 50.0 50.0 -61.7 -80.8 200 200 230 170 190
6/26/2019 04:15:00 50.0 50.0 -61.8 -80.8 200 200 230 170 189
6/26/2019 04:16:00 50.0 50.0 -61.9 -80.8 200 200 230 170 190
6/26/2019 04:17:00 50.0 50.0 -62.1 -80.9 200 200 230 170 190

-------------------------------------------
Approved by Date Page: 87 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/26/2019 04:18:00 50.0 50.0 -62.3 -80.9 200 200 230 170 190
6/26/2019 04:19:00 50.0 50.0 -62.4 -80.9 201 200 230 170 190
6/26/2019 04:20:00 50.0 50.0 -62.6 -80.9 200 200 230 170 190
6/26/2019 04:21:00 50.0 50.0 -62.8 -81.0 200 200 230 170 190
6/26/2019 04:22:00 50.0 50.0 -63.0 -80.9 200 200 230 170 190
6/26/2019 04:23:00 50.0 50.0 -63.2 -81.0 200 200 230 170 190
6/26/2019 04:24:00 50.0 50.0 -63.4 -81.0 200 200 230 170 190
6/26/2019 04:25:00 50.0 50.0 -63.5 -81.0 200 200 230 170 189
6/26/2019 04:26:00 50.0 50.0 -63.7 -81.0 200 200 230 170 189
6/26/2019 04:27:00 50.0 50.0 -63.8 -81.0 200 200 230 170 190
6/26/2019 04:28:00 50.0 50.0 -64.0 -81.0 200 200 230 170 189
6/26/2019 04:29:00 50.0 50.0 -64.1 -81.0 200 200 230 170 190
6/26/2019 04:30:00 50.0 50.0 -64.3 -81.0 200 200 230 170 189
6/26/2019 04:31:00 50.0 50.0 -64.4 -81.0 200 200 230 170 190
6/26/2019 04:32:00 50.0 50.0 -64.6 -81.1 199 200 230 170 189
6/26/2019 04:33:00 50.0 50.0 -64.7 -81.0 200 200 230 170 190
6/26/2019 04:34:00 50.0 50.0 -64.9 -81.1 200 200 230 170 189
6/26/2019 04:35:00 50.0 50.0 -65.0 -81.1 200 200 230 170 190
6/26/2019 04:36:00 50.0 50.0 -65.2 -81.2 200 200 230 170 190
6/26/2019 04:37:00 50.0 50.0 -65.3 -81.2 200 200 230 170 190
6/26/2019 04:38:00 50.0 50.0 -65.5 -81.2 200 200 230 170 190
6/26/2019 04:39:00 50.0 50.0 -65.6 -81.2 200 200 230 170 190
6/26/2019 04:40:00 50.0 50.0 -65.8 -81.2 200 200 230 170 190
6/26/2019 04:41:00 50.0 50.0 -65.9 -81.2 200 200 230 170 190
6/26/2019 04:42:00 50.0 50.0 -66.1 -81.2 200 200 230 170 190
6/26/2019 04:43:00 50.0 50.0 -66.2 -81.2 200 200 230 170 190
6/26/2019 04:44:00 50.0 50.0 -66.3 -81.2 200 200 230 170 190

-------------------------------------------
Approved by Date Page: 88 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/26/2019 04:44:40 Audit: - Alarm is reset manually by IDIN.
6/26/2019 04:45:00 50.0 50.0 -66.4 -81.2 200 200 230 170 190
6/26/2019 04:46:00 50.0 50.0 -66.6 -81.2 200 200 230 170 190
6/26/2019 04:47:00 50.0 50.0 -66.7 -81.2 200 200 230 170 190
6/26/2019 04:48:00 50.0 50.0 -66.8 -81.2 200 200 230 170 190
6/26/2019 04:49:00 50.0 50.0 -66.9 -81.2 200 200 230 170 190
6/26/2019 04:50:00 50.0 50.0 -67.0 -81.2 200 200 230 170 190
6/26/2019 04:51:00 50.0 50.0 -67.1 -81.2 200 200 230 170 190
6/26/2019 04:52:00 50.0 50.0 -67.2 -81.3 200 200 230 170 191
6/26/2019 04:53:00 50.0 50.0 -67.2 -81.2 200 200 230 170 191
6/26/2019 04:54:00 50.0 50.0 -66.2 -81.2 200 200 230 170 191
6/26/2019 04:55:00 50.0 50.0 -58.1 -81.2 200 200 230 170 191
6/26/2019 04:56:00 50.0 50.0 -56.7 -81.2 200 200 230 170 191
6/26/2019 04:57:00 50.0 50.0 -56.5 -81.2 200 200 230 170 191
6/26/2019 04:58:00 50.0 50.0 -56.4 -81.1 200 200 230 170 191
6/26/2019 04:59:00 50.0 50.0 -56.4 -81.1 200 200 230 170 191
6/26/2019 05:00:00 50.0 50.0 -56.4 -81.1 200 200 230 170 191
6/26/2019 05:01:00 50.0 50.0 -56.3 -81.1 200 200 230 170 192
6/26/2019 05:02:00 50.0 50.0 -56.1 -81.1 200 200 230 170 191
6/26/2019 05:03:00 50.0 50.0 -55.9 -81.0 200 200 230 170 192
6/26/2019 05:04:00 50.0 50.0 -55.8 -81.0 200 200 230 170 191
6/26/2019 05:05:00 50.0 50.0 -55.8 -81.0 200 200 230 170 192
6/26/2019 05:06:00 50.0 50.0 -55.8 -81.0 201 200 230 170 192
6/26/2019 05:07:00 50.0 50.0 -55.7 -80.9 200 200 230 170 191
6/26/2019 05:08:00 50.0 50.0 -56.1 -80.9 200 200 230 170 192
6/26/2019 05:09:00 50.0 50.0 -56.9 -80.9 200 200 230 170 192
6/26/2019 05:10:00 50.0 50.0 -57.2 -80.9 200 200 230 170 192

-------------------------------------------
Approved by Date Page: 89 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/26/2019 05:11:00 50.0 50.0 -57.3 -80.9 200 200 230 170 191
6/26/2019 05:12:00 50.0 50.0 -57.4 -80.9 200 200 230 170 192
6/26/2019 05:13:00 50.0 50.0 -57.5 -80.9 200 200 230 170 191
6/26/2019 05:14:00 50.0 50.0 -57.2 -80.9 200 200 230 170 192
6/26/2019 05:15:00 50.0 50.0 -57.0 -80.9 200 200 230 170 191
6/26/2019 05:16:00 50.0 50.0 -56.7 -80.8 200 200 230 170 192
6/26/2019 05:17:00 50.0 50.0 -56.5 -80.8 200 200 230 170 191
6/26/2019 05:18:00 50.0 50.0 -56.3 -80.8 200 200 230 170 192
6/26/2019 05:19:00 50.0 50.0 -56.1 -80.8 200 200 230 170 191
6/26/2019 05:20:00 50.0 50.0 -56.0 -80.7 200 200 230 170 192
6/26/2019 05:21:00 50.0 50.0 -56.0 -80.7 200 200 230 170 191
6/26/2019 05:22:00 50.0 50.0 -57.1 -80.7 200 200 230 170 192
6/26/2019 05:23:00 50.0 50.0 -57.6 -80.7 200 200 230 170 192
6/26/2019 05:24:00 50.0 50.0 -57.7 -80.7 200 200 230 170 192
6/26/2019 05:25:00 50.0 50.0 -57.5 -80.7 200 200 230 170 192
6/26/2019 05:26:00 50.0 50.0 -57.3 -80.7 200 200 230 170 191
6/26/2019 05:27:00 50.1 50.0 -57.1 -80.7 200 200 230 170 192
6/26/2019 05:28:00 50.1 50.0 -57.0 -80.7 200 200 230 170 192
6/26/2019 05:29:00 50.0 50.0 -56.9 -80.7 200 200 230 170 191
6/26/2019 05:30:00 50.1 50.0 -56.7 -80.7 200 200 230 170 192
6/26/2019 05:31:00 49.9 50.0 -56.6 -80.7 200 200 230 170 192
6/26/2019 05:32:00 50.0 50.0 -56.5 -80.7 200 200 230 170 192
6/26/2019 05:33:00 50.0 50.0 -56.4 -80.7 200 200 230 170 192
6/26/2019 05:34:00 50.0 50.0 -56.4 -80.7 200 200 230 170 191
6/26/2019 05:35:00 50.0 50.0 -56.4 -80.7 200 200 230 170 192
6/26/2019 05:36:00 50.0 50.0 -56.4 -80.7 200 200 230 170 192
6/26/2019 05:37:00 50.0 50.0 -56.4 -80.7 200 200 230 170 192

-------------------------------------------
Approved by Date Page: 90 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/26/2019 05:38:00 50.0 50.0 -56.4 -80.7 200 200 230 170 192
6/26/2019 05:39:00 50.0 50.0 -56.3 -80.7 200 200 230 170 192
6/26/2019 05:40:00 50.0 50.0 -56.8 -80.7 200 200 230 170 192
6/26/2019 05:41:00 50.0 50.0 -57.6 -80.7 200 200 230 170 192
6/26/2019 05:42:00 49.9 50.0 -57.9 -80.7 200 200 230 170 192
6/26/2019 05:43:00 50.0 50.0 -57.8 -80.7 200 200 230 170 191
6/26/2019 05:44:00 50.0 50.0 -57.7 -80.7 200 200 230 170 192
6/26/2019 05:45:00 50.0 50.0 -57.6 -80.7 200 200 230 170 192
6/26/2019 05:46:00 50.0 50.0 -57.4 -80.7 200 200 230 170 192
6/26/2019 05:47:00 50.0 50.0 -57.3 -80.7 200 200 230 170 192
6/26/2019 05:48:00 50.0 50.0 -57.2 -80.7 200 200 230 170 192
6/26/2019 05:49:00 50.0 50.0 -57.1 -80.7 200 200 230 170 191
6/26/2019 05:50:00 50.0 50.0 -57.0 -80.7 200 200 230 170 192
6/26/2019 05:51:00 50.0 50.0 -56.9 -80.7 200 200 230 170 192
6/26/2019 05:52:00 50.0 50.0 -56.9 -80.7 200 200 230 170 192
6/26/2019 05:53:00 50.0 50.0 -56.8 -80.7 200 200 230 170 192
6/26/2019 05:54:00 50.0 50.0 -56.8 -80.7 200 200 230 170 192
6/26/2019 05:55:00 50.0 50.0 -56.8 -80.7 200 200 230 170 192
6/26/2019 05:56:00 50.0 50.0 -56.7 -80.7 200 200 230 170 192
6/26/2019 05:57:00 50.0 50.0 -56.7 -80.7 200 200 230 170 192
6/26/2019 05:58:00 50.0 50.0 -56.6 -80.7 200 200 230 170 192
6/26/2019 05:59:00 50.0 50.0 -56.6 -80.7 200 200 230 170 192
6/26/2019 06:00:00 50.0 50.0 -56.6 -80.7 200 200 230 170 192
6/26/2019 06:01:00 50.0 50.0 -56.6 -80.7 200 200 230 170 192
6/26/2019 06:02:00 50.0 50.0 -56.6 -80.7 200 200 230 170 192
6/26/2019 06:03:00 50.0 50.0 -56.6 -80.7 200 200 230 170 192
6/26/2019 06:04:00 50.0 50.0 -56.6 -80.7 200 200 230 170 192

-------------------------------------------
Approved by Date Page: 91 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/26/2019 06:05:00 50.0 50.0 -56.6 -80.7 200 200 230 170 192
6/26/2019 06:06:00 50.0 50.0 -56.6 -80.7 200 200 230 170 192
6/26/2019 06:07:00 50.0 50.0 -56.6 -80.7 200 200 230 170 192
6/26/2019 06:08:00 50.0 50.0 -56.6 -80.7 200 200 230 170 192
6/26/2019 06:09:00 50.0 50.0 -56.6 -80.7 200 200 230 170 192
6/26/2019 06:10:00 50.0 50.0 -56.6 -80.7 200 200 230 170 192
6/26/2019 06:11:00 50.0 50.0 -56.6 -80.7 200 200 230 170 192
6/26/2019 06:12:00 50.0 50.0 -56.6 -80.7 200 200 230 170 192
6/26/2019 06:13:00 50.0 50.0 -56.6 -80.8 200 200 230 170 192
6/26/2019 06:14:00 50.0 50.0 -56.6 -80.8 200 200 230 170 192
6/26/2019 06:15:00 50.0 50.0 -56.6 -80.8 200 200 230 170 192
6/26/2019 06:16:00 50.0 50.0 -56.6 -80.8 200 200 230 170 192
6/26/2019 06:17:00 50.0 50.0 -56.6 -80.8 200 200 230 170 192
6/26/2019 06:18:00 50.0 50.0 -56.7 -80.8 200 200 230 170 192
6/26/2019 06:19:00 50.0 50.0 -56.7 -80.8 200 200 230 170 192
6/26/2019 06:20:00 50.0 50.0 -56.7 -80.8 200 200 230 170 192
6/26/2019 06:21:00 50.0 50.0 -56.8 -80.9 200 200 230 170 192
6/26/2019 06:22:00 50.0 50.0 -56.7 -80.8 200 200 230 170 192
6/26/2019 06:23:00 49.9 50.0 -56.7 -80.8 200 200 230 170 192
6/26/2019 06:24:00 50.0 50.0 -56.8 -80.8 200 200 230 170 192
6/26/2019 06:25:00 50.0 50.0 -56.8 -80.8 200 200 230 170 192
6/26/2019 06:26:00 50.0 50.0 -56.8 -80.8 200 200 230 170 192
6/26/2019 06:27:00 50.0 50.0 -56.9 -80.9 200 200 230 170 192
6/26/2019 06:28:00 50.0 50.0 -56.8 -80.8 200 200 230 170 192
6/26/2019 06:29:00 50.0 50.0 -56.9 -80.9 200 200 230 170 192
6/26/2019 06:30:00 50.0 50.0 -56.9 -80.9 200 200 230 170 192
6/26/2019 06:31:00 50.0 50.0 -57.0 -80.9 200 200 230 170 192

-------------------------------------------
Approved by Date Page: 92 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/26/2019 06:32:00 50.0 50.0 -57.0 -80.9 200 200 230 170 192
6/26/2019 06:33:00 50.0 50.0 -57.0 -80.9 200 200 230 170 192
6/26/2019 06:34:00 50.0 50.0 -57.1 -80.9 200 200 230 170 192
6/26/2019 06:35:00 50.0 50.0 -57.1 -80.9 200 200 230 170 192
6/26/2019 06:36:00 50.0 50.0 -57.2 -80.9 200 200 230 170 192
6/26/2019 06:37:00 50.0 50.0 -57.2 -80.9 200 200 230 170 192
6/26/2019 06:38:00 50.0 50.0 -57.2 -80.9 200 200 230 170 192
6/26/2019 06:39:00 50.0 50.0 -57.2 -80.9 200 200 230 170 192
6/26/2019 06:40:00 50.0 50.0 -57.2 -80.9 200 200 230 170 192
6/26/2019 06:41:00 50.0 50.0 -57.3 -80.9 200 200 230 170 192
6/26/2019 06:42:00 50.0 50.0 -57.3 -80.9 200 200 230 170 192
6/26/2019 06:43:00 50.0 50.0 -57.3 -81.0 200 200 230 170 192
6/26/2019 06:44:00 50.0 50.0 -57.3 -80.9 200 200 230 170 192
6/26/2019 06:45:00 50.0 50.0 -57.4 -81.0 200 200 230 170 192
6/26/2019 06:46:00 50.0 50.0 -57.4 -80.9 200 200 230 170 192
6/26/2019 06:47:00 50.0 50.0 -57.4 -80.9 200 200 230 170 192
6/26/2019 06:48:00 50.0 50.0 -57.5 -81.0 200 200 230 170 192
6/26/2019 06:49:00 50.0 50.0 -57.5 -81.0 200 200 230 170 192
6/26/2019 06:50:00 50.0 50.0 -57.5 -81.0 200 200 230 170 192
6/26/2019 06:51:00 50.0 50.0 -57.6 -81.0 200 200 230 170 192
6/26/2019 06:52:00 50.0 50.0 -57.7 -81.0 200 200 230 170 192
6/26/2019 06:53:00 50.0 50.0 -57.7 -81.0 200 200 230 170 192
6/26/2019 06:54:00 50.0 50.0 -57.7 -81.0 200 200 230 170 192
6/26/2019 06:55:00 50.0 50.0 -57.8 -81.0 200 200 230 170 192
6/26/2019 06:56:00 50.0 50.0 -57.8 -80.9 200 200 230 170 192
6/26/2019 06:57:00 50.0 50.0 -57.9 -81.0 200 200 230 170 192
6/26/2019 06:58:00 50.0 50.0 -57.9 -80.9 200 200 230 170 192

-------------------------------------------
Approved by Date Page: 93 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/26/2019 06:59:00 50.0 50.0 -57.9 -81.0 200 200 230 170 192
6/26/2019 07:00:00 50.0 50.0 -58.0 -80.9 200 200 230 170 192
6/26/2019 07:01:00 50.0 50.0 -58.1 -81.0 200 200 230 170 192
6/26/2019 07:02:00 50.0 50.0 -58.1 -81.0 200 200 230 170 192
6/26/2019 07:03:00 50.0 50.0 -58.1 -81.0 200 200 230 170 192
6/26/2019 07:04:00 50.0 50.0 -58.2 -80.9 200 200 230 170 192
6/26/2019 07:05:00 50.0 50.0 -58.2 -80.9 200 200 230 170 192
6/26/2019 07:06:00 50.0 50.0 -58.4 -80.9 200 200 230 170 192
6/26/2019 07:07:00 50.0 50.0 -58.6 -80.9 200 200 230 170 192
6/26/2019 07:08:00 50.0 50.0 -58.8 -80.9 200 200 230 170 192
6/26/2019 07:09:00 50.0 50.0 -58.9 -80.9 200 200 230 170 192
6/26/2019 07:10:00 50.0 50.0 -59.1 -80.9 200 200 230 170 192
6/26/2019 07:11:00 50.0 50.0 -59.3 -81.0 200 200 230 170 192
6/26/2019 07:12:00 50.0 50.0 -59.5 -80.9 200 200 230 170 192
6/26/2019 07:13:00 50.0 50.0 -59.6 -80.9 200 200 230 170 192
6/26/2019 07:14:00 50.0 50.0 -59.8 -80.9 200 200 230 170 192
6/26/2019 07:15:00 50.1 50.0 -60.0 -80.9 200 200 230 170 192
6/26/2019 07:16:00 50.0 50.0 -60.3 -80.9 200 200 230 170 192
6/26/2019 07:17:00 50.0 50.0 -60.6 -80.9 200 200 230 170 192
6/26/2019 07:18:00 50.0 50.0 -60.8 -80.9 200 200 230 170 192
6/26/2019 07:19:00 50.0 50.0 -60.9 -80.9 200 200 230 170 192
6/26/2019 07:20:00 50.0 50.0 -61.1 -80.9 200 200 230 170 192
6/26/2019 07:21:00 50.0 50.0 -61.3 -80.9 200 200 230 170 192
6/26/2019 07:22:00 50.0 50.0 -61.5 -80.9 200 200 230 170 192
6/26/2019 07:23:00 50.0 50.0 -61.6 -80.8 200 200 230 170 192
6/26/2019 07:24:00 50.0 50.0 -61.6 -80.9 200 200 230 170 192
6/26/2019 07:25:00 50.0 50.0 -60.9 -80.9 200 200 230 170 191

-------------------------------------------
Approved by Date Page: 94 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/26/2019 07:26:00 50.0 50.0 -60.3 -80.8 200 200 230 170 192
6/26/2019 07:27:00 50.0 50.0 -59.9 -80.8 200 200 230 170 191
6/26/2019 07:28:00 50.0 50.0 -59.7 -80.9 200 200 230 170 192
6/26/2019 07:29:00 50.0 50.0 -59.8 -80.8 200 200 230 170 192
6/26/2019 07:30:00 50.0 50.0 -59.9 -80.9 200 200 230 170 192
6/26/2019 07:31:00 50.0 50.0 -59.7 -80.9 200 200 230 170 192
6/26/2019 07:32:00 50.0 50.0 -59.9 -80.9 200 200 230 170 192
6/26/2019 07:33:00 50.0 50.0 -60.1 -80.8 200 200 230 170 192
6/26/2019 07:34:00 50.0 50.0 -60.2 -80.9 200 200 230 170 192
6/26/2019 07:35:00 50.0 50.0 -59.9 -80.9 200 200 230 170 192
6/26/2019 07:35:30 Event: - Step advanced to [11] Moisture Test
6/26/2019 07:35:35 Event: - The pressure rise test is started.
6/26/2019 07:36:00 50.0 50.0 -59.7 -80.9 174 200 230 170 15
6/26/2019 07:36:55 Event: - Pressure rise test passed.Pressure rise test setpoint value is [10µBar] Pressure rise test setpoint time is
[60Sec.] The final chamber vacuum rise in this test is [1µBar] Pressure rise test process time is [60Sec.]
Event: - Step advanced to [12] Pre-aeration
6/26/2019 07:37:00 50.0 50.0 -59.8 -80.9 - - 230 170 7
6/26/2019 07:38:00 50.0 50.0 -59.8 -80.9 - - 230 170 6
6/26/2019 07:39:00 50.0 50.0 -59.5 -80.9 - - 230 170 5
6/26/2019 07:39:05 Event: - Step advanced to [13] Stoppering
6/26/2019 07:40:00 50.0 50.0 -59.7 -80.9 - - 230 170 5
6/26/2019 07:41:00 49.9 50.0 -59.9 -81.0 - - 230 170 5
6/26/2019 07:42:00 49.7 50.0 -60.1 -81.1 - - 230 170 5
6/26/2019 07:42:05 Event: - Step advanced to [14] Aeration
6/26/2019 07:43:00 49.8 50.0 -60.3 -81.2 - - 230 170 4
6/26/2019 07:44:00 50.0 50.0 -60.5 -81.0 - - 230 170 4
6/26/2019 07:45:00 50.1 50.0 -60.7 -80.8 - - 230 170 4

-------------------------------------------
Approved by Date Page: 95 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/26/2019 07:46:00 50.1 50.0 -60.9 -80.6 - - 230 170 4
6/26/2019 07:47:00 50.1 50.0 -61.0 -80.4 - - 230 170 3
6/26/2019 07:48:00 50.1 50.0 -60.8 -80.3 - - 230 170 3
6/26/2019 07:49:00 50.0 50.0 -61.0 -80.1 - - 230 170 3
6/26/2019 07:50:00 50.0 50.0 -61.1 -79.9 - - 230 170 2
6/26/2019 07:51:00 49.9 50.0 -60.3 -78.9 - - 230 170 2
6/26/2019 07:52:00 49.9 50.0 -59.5 -77.2 - - 230 170 2
6/26/2019 07:53:00 49.9 50.0 -58.4 -74.9 - - 230 170 2
6/26/2019 07:54:00 49.9 50.0 -57.4 -72.6 - - 230 170 2
6/26/2019 07:55:00 50.0 50.0 -56.4 -70.7 - - 230 170 2
6/26/2019 07:55:51 Audit: - Trend.grpDuration.strDuration.CurrentValue set to 5 by IDIN.
6/26/2019 07:55:58 Audit: - Trend.grpDuration.strDuration.CurrentValue set to 50 by IDIN.
6/26/2019 07:56:00 50.0 50.0 -55.6 -68.7 - - 230 170 2
6/26/2019 07:57:00 50.1 50.0 -54.2 -66.8 - - 230 170 2
6/26/2019 07:58:00 50.1 50.0 -52.9 -64.8 - - 230 170 2
6/26/2019 07:59:00 50.0 50.0 -52.0 -63.0 - - 230 170 2
6/26/2019 08:00:00 50.0 50.0 -51.0 -61.1 - - 230 170 2
6/26/2019 08:01:00 49.9 50.0 -50.2 -59.3 - - 230 170 19
6/26/2019 08:02:00 49.9 50.0 -49.5 -57.8 - - 230 170 35
6/26/2019 08:03:00 49.9 50.0 -48.9 -56.6 - - 230 170 39
6/26/2019 08:04:00 50.0 50.0 -48.3 -55.5 - - 230 170 42
6/26/2019 08:05:00 50.0 50.0 -47.7 -54.5 - - 230 170 45
6/26/2019 08:05:40 Event: - Step advanced to [15] Storage
6/26/2019 08:06:00 48.3 20.0 -47.1 -53.7 - - 230 170 48
6/26/2019 08:06:26 Alarm: CLOSE - Heater failure.
6/26/2019 08:06:36 Alarm: CLOSE - Heater failure.
6/26/2019 08:06:48 Alarm: CLOSE - Heater failure.

-------------------------------------------
Approved by Date Page: 96 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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)
6/26/2019 08:07:00 44.7 20.0 -46.6 -53.2 - - 230 170 50
6/26/2019 08:07:32 Alarm: CLOSE - Heater failure.
6/26/2019 08:07:40 Alarm: CLOSE - Heater failure.
6/26/2019 08:08:00 42.2 20.0 -46.2 -52.4 - - 230 170 53
6/26/2019 08:09:00 39.9 20.0 -45.7 -51.9 - - 230 170 56
6/26/2019 08:10:00 38.0 20.0 -45.2 -51.4 - - 230 170 58
6/26/2019 08:11:00 35.9 20.0 -44.8 -50.8 - - 230 170 61
6/26/2019 08:12:00 33.9 20.0 -44.3 -50.1 - - 230 170 63
6/26/2019 08:13:00 31.9 20.0 -44.0 -49.6 - - 230 170 66
6/26/2019 08:13:42 Alarm: CLOSE - Heater failure.
6/26/2019 08:13:58 Alarm: CLOSE - Heater failure.
6/26/2019 08:14:00 29.8 20.0 -43.6 -49.5 - - 230 170 68
6/26/2019 08:15:00 27.9 20.0 -43.2 -49.6 - - 230 170 71
6/26/2019 08:15:02 Alarm: CLOSE - Heater failure.
6/26/2019 08:15:05 Alarm: CLOSE - Heater failure.
6/26/2019 08:16:00 25.9 20.0 -42.9 -49.4 - - 230 170 74
6/26/2019 08:16:07 Alarm: CLOSE - Heater failure.
6/26/2019 08:17:00 23.9 20.0 -42.5 -48.9 - - 230 170 76
Alarm: CLOSE - Heater failure.
6/26/2019 08:18:00 21.8 20.0 -42.3 -48.2 - - 230 170 79
6/26/2019 08:18:23 Alarm: CLOSE - COM1 motor over temperature.
6/26/2019 08:18:25 Audit: - The freeze drying cycle is advanced to the next step by IDIN.
Event: - Auto freeze drying advanced to next step.
6/26/2019 08:18:30 20.7 20.0 -42.1 -48.0 - - 230 170 80
Event: - Auto freeze drying cycle ended.

-------------------------------------------
Approved by Date Page: 97 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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
6/24/2019 6/24/2019 6/25/2019 6/25/2019 6/25/2019 6/25/2019 6/25/2019 6/25/2019 6/26/2019 6/26/2019
16:05 20:15 0:20 4:25 8:30 12:35 16:40 20:45 0:50 4:55
Date/Time(M/D/YYYY HH:MM:SS)

-------------------------------------------
Approved by Date Page: 98 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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
6/24/2019 6/24/2019 6/25/2019 6/25/2019 6/25/2019 6/25/2019 6/25/2019 6/25/2019 6/26/2019 6/26/2019
16:05:00 20:15:00 00:20:00 04:25:00 08:30:00 12:35:00 16:40:00 20:45:00 00:50:00 04:55:00
Date/Time(M/D/YYYY HH:MM:SS)

-------------------------------------------
Approved by Date Page: 99 of 100
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190624160819 Batch Series Number 1273
Batch Start Time 6/24/2019 16:08:19 Batch End Time 6/26/2019 08:18:30
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
6/24/2019 6/24/2019 6/25/2019 6/25/2019 6/25/2019 6/25/2019 6/25/2019 6/25/2019 6/26/2019 6/26/2019
16:05:00 20:15:00 00:20:00 04:25:00 08:30:00 12:35:00 16:40:00 20:45:00 00:50:00 04:55:00
Date/Time(M/D/YYYY HH:MM:SS)

-------------------------------------------
Approved by Date Page: 100 of 100

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