| Inspection Category |
Inspection field |
Range of inspection |
Stage of Inspection |
Inspection criteria |
Inspection Activity Type |
Status |
| Lifting Equipment |
| - Mechanical, Electrical and Structural Engineering of Lifting Equipment
| | | BS 7121-2-1 | A | Active
|
| Environmental Monitoring |
| - Containment Devices Biosafety Cabinet Class II A1 Class II A2 Class II B1 Class II B2
| - 01. Airflow test 02. Air flow volume 03. Smoke pattern 04. Differential pressure 05. Leak test 06. Particle count 07. Noise 08. Light 09. Site installation assessment
| | - NSF/ANSI49 - EN12469 - Manufacture requirements - Customer Requirement when it is referred to known guideline - ISO 14644-3:2019 | A | Active
|
- Containment Devices Terminal HEPA Filter
| - 01. Airflow velocity 02. Air flow volume 03. Smoke pattern 04. Differential pressure 05. Leak test 06. Particle count
| -IEST-RP-CC002.3 -IEST-PR-CC006.3 -Customer Requirement when it is referred to known guideline | A | Active
|
- Clean Room-Class 10000 C ISO7: Sterile compounding Facilities,Operation Theater,Isolation protective room,Intravenous fluid rooms IVF,Hospital room listed in ashre 170,Control Environment Laboratory,Control Environment (Air borne Infection Isolation
| - 01. Airborne particle count 02. Airflow test (Air change per hour) 03. Air pressure difference test 04. Installed filter system leakage test 05. Airflow direction test and visualization 06. Temperature test 07. Humidity test 08. Noise 09. Light
| -USP797, USP800 -CETACAG-001 -CETACAG-002 -CETACAG-003 -ISO 14644, Part 1&3 -Manufacture requirements -Customer Requirement -Guidelines for Environmental Infection Control in Health-Care Facilities CDC GA 30329 -ASHRAE 170 -IEST PRCC006.3 | A | Active
|
| '-EU GMP annex 1 -EudraLex Vol 4 -USP797, USP800, -CETACAG-001, -CETACAG-002, -CETACAG-003. -ISO 14644, Part 1&3 -Manufacture requirements -Customer Requirement -CDC Guideline ASHRAE 170 -IEST-PRCC006.3. | A | Active
|
- Clean Room-Class 100000 D ISO8:Sterile Compounding Facilities,Operation Theater,Isolation protective Room,Intravenous Fluid Rooms IVF,Hospital Room Listed in ASHRAE 170,Control Environment Laboratory,Control Environment (Air borne Infection Isolation
| - 01. Airflow velocity 02. Air flow volume 03. Smoke pattern 04. Differential pressure 05. Leak test 06. Particle count 07. Noise 08. Light 09. Temperature 10. Humidity 11. VOC
| '-EU GMP annex 1 -EudraLex Vol 4 -USP797, USP800, -CETACAG-001, -CETACAG-002, -CETACAG-003. -ISO 14644, Part 1&3 -Manufacture requirements -Customer Requirement -CDC Guideline ASHRAE 170 -IEST-PRCC006.3 | A | Active
|
- Clean Room-Class 1000000 ISO9:Sterile Compounding Facilities,Operation Theater,Isolation protective Room,Intravenous Fluid Rooms IVF,Hospital Room Listed in ASHRAE 170,Control Environment Laboratory,Control Environment (Air borne Infection Isolation
| '-EU GMP annex 1 -EudraLex Vol 4 -USP797, USP800, -CETACAG-001, -CETACAG-002, -CETACAG-003. -ISO 14644, Part 1&3 -Manufacture requirements -Customer Requirement -CDC Guideline ASHRAE 170 -IEST-PRCC006.3 | A | Active
|