A cleanroom is only as clean as its last certification proves. For compounding pharmacies, IVF labs and research cleanrooms, certification is the evidence that air is moving, filtered and pressurized the way the room was designed. Here is what gets tested and how often.
How often cleanrooms are certified
Compounding cleanrooms and their primary engineering controls, such as biosafety cabinets and compounding aseptic isolators, are certified at least every six months under USP <797> and <800>. Certification is also needed:
- Before a new or renovated room is used
- After a primary engineering control is installed or moved
- After major HVAC changes or repairs
- When investigating a contamination problem
Cleanrooms outside compounding usually follow ISO 14644 and the schedule in your own quality system.
What the certification measures
- Airflow and air changes: supply air volume through each HEPA filter, converted to air changes per hour
- HEPA filter integrity: a leak test across each filter face and seal
- Non-viable particle counts: airborne particles counted and compared to the room's ISO class, such as ISO 5, 7 or 8
- Pressure differentials: each room's pressure relative to the next, positive for sterile compounding and negative for hazardous drugs
- Airflow visualization: smoke studies showing air moves in the right direction at hood openings and doorways
- Viable sampling: air and surface samples cultured for microbial growth, on the schedule USP sets for your compounding category
What the report should include
- Every measured value next to its acceptance limit
- The ISO class achieved for each room and hood
- Test methods and the standards followed
- Instrument calibration information for the certifier's equipment
- Any failures, with the corrective action and retest results
- Date, certifier credentials and next due date
One schedule for the whole suite
Cleanroom suites, biosafety cabinets and fume hoods often sit side by side. Certifying them on one visit keeps the dates aligned and the reports in one place. BMCA manages cleanroom certification across Florida and Puerto Rico, with field testing by our certification partner, Medrep Technologies. See also biosafety cabinet certification.