Validation & Qualification Facillity

No. Description
1 Water Treatment Plan
a Develop Design & URS (DQ)
b Material Approval
c Develop Critical Quality Attributes (CQA) and Critical Process Parameter (CPP)
d Develop Protocol and Execution Installation Qualification (IQ)
c Develop SOP & Conduct Training
d Testing & Commissioning
c Develop Protocol & Execution Operational Qualification (OQ)
d Develop Protocol & Excecution Perfomance Qualification (PQ)
2 RO System
a Develop Design & URS (DQ)
b Material Approval
c Develop Critical Quality Attributes (CQA) and Critical Process Parameter (CPP)
d Develop Protocol and Execution Installation Qualification (IQ)
c Develop SOP & Conduct Training
d Testing & Commissioning
c Develop Protocol & Execution Operational Qualification (OQ)
d Develop Protocol & Excecution Perfomance Qualification (PQ)
3 Purified Water
a Develop Design & URS (DQ)
b Material Approval
c Develop Critical Quality Attributes (CQA) and Critical Process Parameter (CPP)
d Develop Protocol and Execution Installation Qualification (IQ)
c Develop SOP & Conduct Training
d Testing & Commissioning
c Develop Protocol & Execution Operational Qualification (OQ)
d Develop Protocol & Excecution Perfomance Qualification (PQ)
4 Water For Injection
a Develop Design & URS (DQ)
b Material Approval
c Develop Critical Quality Attributes (CQA) and Critical Process Parameter (CPP)
d Develop Protocol and Execution Installation Qualification (IQ)
c Develop SOP & Conduct Training
d Testing & Commissioning
c Develop Protocol & Execution Operational Qualification (OQ)
d Develop Protocol & Excecution Perfomance Qualification (PQ)
5 Pure Steam
a Develop Design & URS (DQ)
b Material Approval
c Develop Critical Quality Attributes (CQA) and Critical Process Parameter (CPP)
d Develop Protocol and Execution Installation Qualification (IQ)
c Develop SOP & Conduct Training
d Testing & Commissioning
c Develop Protocol & Execution Operational Qualification (OQ)
d Develop Protocol & Excecution Perfomance Qualification (PQ)
6 Compress Air
a Develop Design & URS (DQ)
b Material Approval
c Develop Critical Quality Attributes (CQA) and Critical Process Parameter (CPP)
d Develop Protocol and Execution Installation Qualification (IQ)
c Develop SOP & Conduct Training
d Testing & Commissioning
c Develop Protocol & Execution Operational Qualification (OQ)
d Develop Protocol & Excecution Perfomance Qualification (PQ)
7 HVAC System (Production Area & Laboratory Area)
a Develop Design & URS (DQ)
b Material Approval
c Develop Critical Quality Attributes (CQA) and Critical Process Parameter (CPP)
d Develop Protocol and Execution Installation Qualification (IQ)
c Develop SOP & Conduct Training
d Testing & Commissioning
c Develop Protocol & Execution Operational Qualification (OQ)
d Develop Protocol & Excecution Perfomance Qualification (PQ)
8 Building Automation System
a Develop Design & URS (DQ)
b Material Approval
c Develop Critical Quality Attributes (CQA) and Critical Process Parameter (CPP)
d Develop Protocol and Execution Installation Qualification (IQ)
c Develop SOP & Conduct Training
d Testing & Commissioning
c Develop Protocol & Execution Operational Qualification (OQ)
d Develop Protocol & Excecution Perfomance Qualification (PQ)
9 Cold Storage for Ware House
a Develop Design & URS (DQ)
b Material Approval
c Develop Critical Quality Attributes (CQA) and Critical Process Parameter (CPP)
d Develop Protocol and Execution Installation Qualification (IQ)
c Develop SOP & Conduct Training
d Testing & Commissioning
c Develop Protocol & Execution Operational Qualification (OQ)
d Develop Protocol & Excecution Perfomance Qualification (PQ)
idation & Qualification Facillity

Scope Of Work/Constraints Remark

P&ID
Isometric Loop (BAS)
Instrument Calibration
Back Up Software PLC and HMI Siemens
Passivation
Welding Record
Inspection by Borescope
Contaminated/Damage Part
Lab Test (pH, TOC, Microbiolgy, etc)
P&ID
Isometric Loop (BAS)
Instrument Calibration
Back Up Software PLC and HMI Siemens
Passivation
Welding Record
Inspection by Borescope
Contaminated/Damage Part
Lab Test (pH, TOC, Microbiolgy, etc)
P&ID
Isometric Loop (BAS)
Instrument Calibration
Back Up Software PLC and HMI Siemens
Passivation
Welding Record
Inspection by Borescope
Contaminated/Damage Part
Lab Test (pH, TOC, Microbiolgy, etc)
P&ID
Isometric Loop (BAS)
Instrument Calibration
Back Up Software PLC and HMI Siemens
Passivation
Welding Record
Inspection by Borescope
Contaminated/Damage Part
Lab Test (pH, TOC, Microbiolgy, etc)
P&ID
Isometric Loop (BAS)
Instrument Calibration
 Back Up Software PLC and HMI Siemens
Passivation
Welding Record
Inspection by Borescope
Contaminated/Damage Part
Lab Test (pH, TOC, Microbiolgy, etc)
P&ID
Isometric Loop (BAS)
Instrument Calibration
Back Up Software PLC and HMI Siemens
Passivation
Piping Leak Test
Inspection by Borescope
Contaminated/Damage Part
Lab Test (Hydrocarbon, Particle, Oil, Microbiology, dew Point)
Schematic
Layout Duct
Instrument Calibration
Back Up Software PLC and HMI Siemens
Check Pressurize
Duct Leak Test
HEPA filter Leak Test
Balancing Chiller
Balancing Air Supply
Schematic
Layout
Instrument Calibration
Back Up Software PLC and HMI Siemens

Schematic
Layout
Instrument Calibration
Back Up Software PLC and HMI Siemens
Data Logging System
Equipment to be Qualified
Production
No Machine/Devices
1 Vertical Ultrasonic Washing Machine
2 Sterilizing & Drying Tunnel
3 Filling and Stoppering Machine
4 Capping Machine
5 Labelling Machine
6 Biological Safety Cabinet
7 Laminar Air Flow Hoods
8 Laminar Air Flow Hoods
9 Laminar Air Flow Hoods
10 Laminar Air Flow Hoods
11 Laminar Air Flow Hoods
12 Laminar Air Flow Hoods
13 Laminar Air Flow Hoods
14 Laminar Air Flow Hoods
15 Laminar Air Flow Hoods
16 Laminar Air Flow Hoods
17 Laminar Air Flow Hoods
18 Laminar Air Flow Hoods
19 Laminar Air Flow Hoods
20 Laminar Air Flow Hoods
21 Pulse Vacuum Sterilizer
22 Pulse Vacuum Sterilizer
23 Pulse Vacuum Sterilizer
24 Pulse Vacuum Sterilizer
25 Pulse Vacuum Sterilizer
26 Pulse Vacuum Sterilizer
27 Dry heat
28 Inkubator Telur R.Pra
29 Inkubator Telur R.Pra
30 Inkubator Telur R.Pra
31 Inkubator Telur R.Pra
32 Cold Room (2~8 deg)
33 Cold Room (2~8 deg)
34 Cold Room (2~8 deg)
35 Cold Room (2~8 deg)
36 Cold Room (2~8 deg)
37 Cold Room (2~8 deg)
38 Cold Room (2~8 deg)
39 Drying Room (40±5 deg)
40 Bio Cultivationg Box | Incubator Media
41 Balance Analytical

QC
No Machine/Devices
1 Bio Cultivationg Box | Incubator Media
2 Bio Cultivationg Box | Incubator Media
3 Bio Cultivationg Box | Incubator Media
4 Bio Cultivationg Box | Incubator Media
5 Bio Cultivationg Box | Incubator Media
6 Bio Cultivationg Box | Incubator Media
9 Egg incubator
10 Biological Safety Cabinet
11 Biological Safety Cabinet
12 Biological Safety Cabinet
13 Biological Safety Cabinet
15 Pulse Vacuum Sterilizer
16 Pulse Vacuum Sterilizer
16 Autoclave Portable
17 Dry heat
18 Refrigerator
19 Refrigerator
20 Refrigerator
21 Refrigerator
22 Ultra-low freezer -80
27 Particle counter
28 Total Organic Carbon
29 Balance analytical
30 Balance analytical
31 pH meter
32 Waterbath
33 Conductivity test equipment
34 Spectrophotometer
35 Fume hood
36 Viscometer
37 Caliper
38 Thermohygrometer
39 Freezer thermometer
40 Biuret titrator
41 Oven
 Merk Qty Room Remark
Truking Technology Limited 1 B-803
Truking Technology Limited 1 B-803
TOFFLON 1 B-709
TOFFLON 1 B-711
TOFFLON 1 B-129
Suzhou Antai Airtech Co.LTD 1 B-707
2 B-606
2 B-905
24 B-709
4 B-117
2 B-209
2 B-508
2 B-506
2 B-405
2 B-413
2 B-409
2 B-411
4 B-305
4 B-310
2 B-312
Shandong Xinhua Medical Instrument Co.Ltd., 1 B-803
Shandong Xinhua Medical Instrument Co.Ltd., 1 B-806
Shandong Xinhua Medical Instrument Co.Ltd., 1 B-127
Shandong Xinhua Medical Instrument Co.Ltd., 1 B-604
Shandong Xinhua Medical Instrument Co.Ltd., 1 B-118
Shandong Xinhua Medical Instrument Co.Ltd., 1 B-117
Shandong Xinhua Medical Instrument Co.Ltd., 1 B-604
Qingdao Xingyi Electronic Equipment 1 B-206
Qingdao Xingyi Electronic Equipment 1 B-206
Qingdao Xingyi Electronic Equipment 1 B-206
Qingdao Xingyi Electronic Equipment 1 B-206
Kontraktor: CESE 2 1 B-213 34.5 m2 x 2.7 m
Kontraktor: CESE 2 1 B-212 24 m2 x 2.7 m
Kontraktor: CESE 2 1 B-126 18.8 m2 x 2.7 m
Kontraktor: CESE 2 1 B-408 14.8 m2 x 2.7 m
Kontraktor: CESE 2 1 B-407 11.4 m2 x 2.7 m
Kontraktor: CESE 2 1 B-308 7.3 m2 x 2.7 m
Kontraktor: CESE 2 1 B-309 14.5 m2 x 2.7 m
Kontraktor: CESE 2 1 B-607 14.5 m2 x 2.7 m
Shanghai Sumsung Laboratory Instrument Co.Ltd., 5 B-114
 1 B-905

Merk Qty Room Remark

Shanghai Sumsung Laboratory Instrument Co.Ltd., 1 D-128
Shanghai Sumsung Laboratory Instrument Co.Ltd., 1
Shanghai Sumsung Laboratory Instrument Co.Ltd., 1
Shanghai Sumsung Laboratory Instrument Co.Ltd., 1
Shanghai Sumsung Laboratory Instrument Co.Ltd., 1
Shanghai Sumsung Laboratory Instrument Co.Ltd., 1
1 D-305
Suzhou Antai Airtech Co.LTD 1 D-305
Suzhou Antai Airtech Co.LTD 1 D-206
Suzhou Antai Airtech Co.LTD 1 D-404
Suzhou Antai Airtech Co.LTD 1 D-404
Shandong Xinhua Medical Instrument Co.Ltd., 1 D-116
Shandong Xinhua Medical Instrument Co.Ltd., 1 D-305
1
Shandong Xinhua Medical Instrument Co.Ltd., 1 D--116
1
1
1
1
1
Lighthouse 1
Teledyne Tekmar 1 D-125
1
1
1
1
1
Eppendorf 1
1
1
Insize 1
Sanfix 1
Sanfix 1
1
1