| Inspection Category |
Inspection field |
Range of inspection |
Stage of Inspection |
Inspection criteria |
Inspection Activity Type |
Status |
| Pressure Equipment |
| - Mechanical, Electrical and Structural Engineering of Pressure Equipment
| | | ASME BPVC Section I | A | Active
|
| Environmental Monitoring |
| - 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
|
- 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
|
- Containment Devices Biosafety Cabinet Class II A1 Class II A2 Class II B1 Class II B2
| - 01. Airflow test 02. Airflow direction test and visualization 03. Installed filter system leakage test 04. Air pressure difference test 05. Airborne particle count 06. Noise 07. Light 08. Electrical safety test 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 Biosafety Cabinet Class I
| - NSF/ANSI49 - EN12469 - Manufacture requirements - Customer Requirement when it is referred to known guideline - ISO 14644-3:2019 | A | Active
|
- Containment Devices Laminar Flow Hood Vertical Horizontal
| - 01. Airflow velocity 02. Air flow volume 03. Smoke pattern 04. Differential pressure 05. Leak test 06. Particle count 07. Noise 08. Light 09. Containment leak test 10. Electrical safety test
| -IEST-RP-CC002.3 -Manufacture requirements -Customer Requirement when it is referred to known guideline | A | Active
|
- Containment Devices Chemical Fume Hood Ducted Ductless (recirculating)
| - 01. Cross draft velocity test 02. Face Velocity test 03. Site installation test (Sash alarm verification) 04. Smoke pattern test 05. Light intensity test 06. Noise Level test
| -ASHRAE 110 -SEFA 1 -ANSI/AIHA Z.95 -Manufacture requirements -Customer Requirement when it is E21referred to known guideline | A | Active
|
- Containment Devices Isolator
| - 01. Main airflow velocity test 02. Main work zone chamber airborne chamber particle counter test 03. Pass through air chamber particle count test 04. HEPA filter leak test 05. Prepration ingress and egress test 06. Chanmber pressure test 07. Airflow
| -CETACAG-002 -ISO 14644-7 -Volume 4 EU Guidelines to Good Manufacturing Practice 2008 -Manufacture requirements -Customer Requirement when it is referred to known guideline | A | Active
|
- Containment Devices Glove boxes
| - 01. Airflow velocity 02. Air flow volume 03. Smoke pattern 04. Differential pressure 05. Leak test 06. Particle count 07. Noise 08. Light 09. Containment leak test 10. Electrical safety test
| -CETACAG-002 -ISO 14644-7 -Volume 4 EU Guidelines to Good Manufacturing Practice 2008 -Manufacture requirements -Customer Requirement when it is referred to known guideline | A | Active
|
