| Inspection Category |
Inspection field |
Range of inspection |
Stage of Inspection |
Inspection criteria |
Inspection Activity Type |
Status |
| Environmental Monitoring |
| - Containment Devices Vertical and Horizontal Laminar Flow Cabinet
| - Air Flow Velocity Test, Smoke Pattern Test, Noise Level Test, Light Intensity Test, UV Intensity Test, Leak Particle Counter Test, Filter Leak Test Electrical safety test, Sash Alarm Function Induction Leak Test
| | IEST-RP-CC002.4 Manufacturer specifications Customer acceptance limits based on known standard method | A | Active
|
- Containment Devices Biosafety Cabinet Class II A1 Class II A2 Class II B1 Class II B2
| - Downflow Airflow Velocity Test, Inflow Airflow Velocity Test, Smoke Pattern Test, Airborne particle count/concentration Airflow direction test and visualization Noise Level Test, Light Intensity Test, UV Light Intensity Test, HEPA/ULPA Filter Leak Te
| ce -NSF/ANSI49EN12469 ISO 14644-3 Manufacturer specifications Customer acceptance limits based on known standard method | A | Active
|
- Fume Hood (ducted and ductless)
| - Airflow velocity test, Airflow volume test, Smoke visualization/pattern test, Gas Containment Test, Noise Level test, Light intensity test, Sash alarm function test, Electrical safety test, Site installation test
| ASHRAE 110 -SEFA 1 ANSI/AIHA/ASSP Z9Manufacturer specifications Customer acceptance limits based on known standard method | A | Active
|
| - Downflow Velocity Inflow Velocity Smoke Pattern Test, Noise Level test Light Intensity Test, (Lux) Differential Pressure Test, (Pa) Work zone chamber airborne chamber particle counter test, UV light intensity test, HEPA Filter Integrity Test, Electri
| CETACAG-002 ISO 14644-7 EudraLex Volume 4 EU Guidelines to Good Manufacturing Practice Manufacturer specifications Customer acceptance limits based on known standard method | A | Active
|
- Containment Devices Terminal HEPA Filter
| - Airflow velocity Airflow volume Airflow changes per hour Smoke visualization/pattern test Differential pressure Leak test Particles count/concentration test
| USA Department of Energy standard DOE-STD-3020-2015 IEST-RP-CC002.4 IEST-RP CC006.3 Customer acceptance limits based on known standard method | A | Active
|
- Clean Room -Sterile compounding Facilities -Operation Theater -Isolation protective room-Intravenous fluid rooms IVF -Hospital room listed in ashre 170 -Controlled Environment Laboratory -Controlled Environment (Airborne Infection Isolation Room) -Pr
| - Airborne particle count Airflow test Air change per hour Airflow direction test and visualization Differential pressure test Filter system leakage test Temperature test Humidity test Noise level Visible Light intensity
| USP 795 USP797 USP800 CETA Application Guide 001, 002, 003 -ISO 14644, Part 1&3 Manufacturer specifications Customer acceptance limits based on known standard method Guidelines for Environmental Infection Control in Health Care Facilities CDC GA 3032 | A | Active
|
