Purpose of Clean Room Validation
1.To verify compliance with design specifications
InClean room airflow, temperature, humidity, differential pressure, particle count, etc. should be maintained as per design. The manufacturing area is divided into classes A (for devices) B, C & D according to their particle concentration through HEPA filters.
2.To ensure environmental control
It should be ensured that in controlled environment airborne particles, microbial contamination should be controlled so that there is no effect on the product and patient in Hospitals (OT, ICU, NICU etc.)
3.To demonstrate effectiveness of HVAC system
To check HEPA filter efficiency, air change rate, airflow pattern and airborne particle is controlled or not.
4.To maintain regulatory compliance
As per Validation GMP (Good Manufacturing Practice), ISO 14644, or NABH/NABL guidelines
5.To ensure product & personnel safety
All these testes ensure that the controlled room environment is free from contamination, which is especially critical in pharmaceuticals, medical devices manufacturing and hospitals.
Parameters to be tested
| 1. Particle monitoring Test in every 6 month |
| 2. HEPA filter Integrity Test, yearly |
| 3. Air changes rate in every 6 month |
| 4. Air visualization Test, yearly |
| 5. Air pressure differential test in yearly |
| 6. Temperature & Humidity Test |
| 7. Recovery Test, yearly |
| 8. Light Intensity Test |
| 9. Noise Intensity Test |
Seperative Devices (HEPA Equipped)
Bio Safety Cabinet, Laminar Air Flow Cabinet (Horizontal & Vertical), Dynamic Pass Box, Sterile Dress Cabinet, Hanging LAF, Sampling Booth, Dispensing Booth, PCR Cabinet
Parameters to be tested in sepetative devices
| 1. Particle monitoring Test |
| 2. HEPA filter Integrity Test |
| 3. Air changes rate |
| 4. Air visualization Test |
| 5. Air pressure differential test |
| 6. Temperature & Humidity Test |
| 7. Recovery Test, yearly |
| 8. Light Intensity Test |
| 9. Noise Intensity Test |
Acceptance Criteria
As per ISO 14644-1:2015, EN 12469:2000, EN 1822-1:2009, NSF/ ANSI 49:2019, CGMP Schedule’ M’
Operation Theatre Validation
- Purpose of OT validation
The purpose of OT validation is to verify the indoor air quality as per NABH guidelines to improve healthcare quality and patient safety based on ISO 14644 standard.
- Types of OT
The operation theatres have been divided into two groups
Type A (Erstwhile Super specialty OT): This includes operation theatres for Neurosciences, Orthopedics (Joint Replacement), Cardiothoracic and Transplant Surgery (Renal, Liver, heart etc.).
Type B (Erstwhile General OT): This includes operation theatres for Ophthalmology, day-care surgeries and all other basic surgical disciplines.
- Parameters To be Tested
Validation of system should be done every 6 month as per ISO 14644
- Air changes per hour
- Air velocity
- Pressure Differential levels of the OT with respect to ambient / adjoining areas
- Air particulate count
- Temperature and Humidity
- HEPA filter Integrity Test