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Section1:Overview
Catalog
No. Item Value
1 Section1 Section1:Overview
2 Section2 Section2:Freeze Drying Recipe
3 Section3 Section3:Operation Parameters
4 Section4 Section4:History trend
Machine Information
No. Item Value
1 Manufacturer Name IMA Life
2 Manufacturer Address 101 Wangjing LizeZhongYuan,Chaoyang,100102,Beijing,China
3 Web Site www.IMALife.com
4 Service Phone 86-10-64399688
5 Service Fax 86-10-64392556
6 Custom Name PT. KALBE FARMA TBK.
Batch Information
No. Item Value
1 Initiator Full Name SAHIDIN
2 Abortor Full Name
3 Product Name PRANZA 40 MG
4 Product Type Vial
5 Product Quantity 24840
6 Container Size 10
7 Container Quantity 24840
8 Container Fill Volume 3
9 Product Container Type Vial
10 Batch Name AFD20190704155459
11 Batch Series Number 1288
12 Batch Comments PRANZA 40 MG BN (VPRZA90060)
13 Batch Description 4-Jul-19
14 Batch Start Time 7/4/2019 15:54
15 Batch End Time 7/6/2019 15:07
16 Batch End Mode Normal
17 Report template name VIT_AFD
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PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Recipe Information
No. Item Value
1 Freeze Drying Recipe Name VPRZ1R
2 Freeze Drying Recipe Number 2030
3 Freeze Drying Recipe Description REDUCE TIME
4 Freeze Drying Recipe Comments PERUBAHAN WAKTU LIOFILISASI
General Parameters
No. Name High Limit Low Limit Value Unit
1 Control vacuum high deviation 1000 0 30 µBar
2 Control vacuum low deviation 1000 0 30 µBar
3 Control vacuum pre-alarm setpoint 1000 0 500 µBar
4 Control vacuum alarm setpoint 1000 0 600 µBar
5 Vacuum control gas selection - - Nitrogen -
6 Pre-aeration gas selection - - Nitrogen -
Step Parameters
Step
Step Step Vacuum Step Time
Step Name Temperature
No.
(°C) (µbar) HH:MM MM:SS
1 Loading 5 -- -- --
2 Freezing 5 -- 0 : 30 --
3 Freezing -45 -- 1 : 40 --
4 Freezing -45 -- 1 : 30 --
5 Evacuation -- 200 -- --
6 Drying 5 200 1 : 40 --
7 Drying 5 200 15 : 0 --
8 Drying 5 200 0:0 --
9 Drying 50 200 1 : 30 --
10 Drying 50 200 6:0 --
11 Moisture Test -- 10 -- 60 : 60
12 Pre-Aeration -- -- -- --
13 Stoppering -- -- -- 0 : 20
14 Aeration -- -- -- --
15 Storage 20 -- 15 : 0 --
The hour part of P.R.T time setpoint is test repeat time(minute),minute part is test time(second).
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Approved by Date Page: 2 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 3 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 4 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 5 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 6 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 7 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 8 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 9 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 10 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 11 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 12 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 13 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 14 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 15 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 16 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 17 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 18 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 19 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 20 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 21 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 22 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 23 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 24 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 25 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 26 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 27 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 28 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 29 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 30 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 31 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 32 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 33 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 34 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 35 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 36 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 37 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 38 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 39 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 40 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 41 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 42 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 43 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 44 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 45 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 46 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 47 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 48 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 49 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 50 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 51 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 52 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 53 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 54 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 55 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 56 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 57 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 58 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 59 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 60 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 61 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 62 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 63 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 64 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 65 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 66 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 67 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 68 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 69 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 70 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 71 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 72 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 73 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 74 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 75 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 76 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 77 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 78 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 79 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 80 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 81 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 82 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 83 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 84 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 85 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 86 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 87 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 88 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 89 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 90 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 91 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 92 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 93 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 94 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 95 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 96 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 97 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 98 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 99 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 100 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 101 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 102 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 103 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 104 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 105 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 106 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 107 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 108 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 109 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 110 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section3:Operation Parameters
-------------------------------------------
Approved by Date Page: 111 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section4:History trend
4-1 AFD-1
Chamber vacuum Chamber vacuum PT102 Control vacuum setpoint Shelf inlet temperature
Shelf outlet temperature Shelf control temperature Condenser coil1 temperature Condenser coil2 temperature
1000 200
900
150
800
700
100
600
µBar
C
500 50
400
0
300
200
-50
100
0 -100
7/4/2019 7/4/2019 7/5/2019 7/5/2019 7/5/2019 7/5/2019 7/5/2019 7/6/2019 7/6/2019 7/6/2019
15:50 20:40 1:25 6:10 10:55 15:40 20:25 1:10 5:55 10:40
Date/Time(M/D/YYYY HH:MM:SS)
-------------------------------------------
Approved by Date Page: 112 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section4:History trend
4-2 AFD-2
Product temperature TE101 Product temperature TE102 Product temperature TE103
Product temperature TE104 Product temperature TE105
200
150
100
C
50
-50
-100
7/4/2019 7/4/2019 7/5/2019 7/5/2019 7/5/2019 7/5/2019 7/5/2019 7/6/2019 7/6/2019 7/6/2019
15:50:00 20:40:00 01:25:00 06:10:00 10:55:00 15:40:00 20:25:00 01:10:00 05:55:00 10:40:00
Date/Time(M/D/YYYY HH:MM:SS)
-------------------------------------------
Approved by Date Page: 113 of 114
PT. KALBE FARMA TBK.
AUTO FREEZE DRYING Batch Report
Project No MBE1115 Model Lyofast 15
Batch Name AFD20190704155459 Batch Series Number 1288
Batch Start Time 7/4/2019 15:54:59 Batch End Time 7/6/2019 15:07:15
Initiator Full Name SAHIDIN Abortor Full Name
Section4:History trend
4-3 AFD-3
Product temperature TE106 Product temperature TE107 Product temperature TE108
Product temperature TE109 Product temperature TE110
200
150
100
C
50
-50
-100
7/4/2019 7/4/2019 7/5/2019 7/5/2019 7/5/2019 7/5/2019 7/5/2019 7/6/2019 7/6/2019 7/6/2019
15:50:00 20:40:00 01:25:00 06:10:00 10:55:00 15:40:00 20:25:00 01:10:00 05:55:00 10:40:00
Date/Time(M/D/YYYY HH:MM:SS)
-------------------------------------------
Approved by Date Page: 114 of 114