The U.S. Food and Drug Administration (FDA) has specific requirements for pharmaceutical cleanrooms under 21 CFR Parts 210 and 211. Key compliance areas include:
Facility Design (21 CFR 211.42)
Buildings must have adequate size, construction, and location to facilitate cleaning, maintenance, and proper operations. Specific requirements for floors, walls, and ceilings.
Environmental Control (21 CFR 211.46)
Adequate ventilation, air filtration (HEPA), temperature/humidity control, and pressure differentials between adjacent areas of different classifications.
Monitoring and Documentation
Continuous environmental monitoring programs with documented procedures, action/alert limits, and investigation protocols for excursions. Sz Pharma cleanroom solutions are designed to meet or exceed all FDA requirements.