USP 797 and 800: The Future of Safe Compounding
Why USP 797 and 800 Matter
USP Chapters 797 and 800 are revolutionizing pharmaceutical compounding. If you handle sterile or hazardous drugs, compliance isn’t optional—it’s essential. But what do these regulations mean for your facility?
USP 797: The Gold Standard for Sterile Compounding
USP 797 ensures sterile medication compounding occurs in a contamination-free environment. It relies on ISO 14644 cleanroom standards, requiring precise airflow, pressure control, and environmental monitoring to maintain sterility and safety.
Key Requirements:
- Air Quality & Filtration: HEPA filters, HVAC control, ISO-classified cleanrooms.
- ISO Classifications: Buffer rooms (ISO 7), Ante-rooms (ISO 8 or ISO 7 for negative pressure), Primary Engineering Controls (ISO 5).
- Personnel Training: Aseptic techniques, routine testing, and competency validation.
- Monitoring & Beyond-Use Dating (BUD): Environmental sampling, batch sterility testing, risk classification for compounded preparations.
FTS Cleanrooms provides turnkey solutions to ensure full USP 797 compliances, offering modular cleanrooms with optimized airflow and environmental controls.
USP 800: Safe Handling of Hazardous Drugs
USP 800 focuses on minimizing exposure to hazardous drugs, requiring strict containment measures. Unlike USP 797, it mandates negative pressure environments to prevent contamination.
Facility & Safety Requirements:
- Negative Pressure & Ventilation: Hazardous drug rooms must maintain 0.01–0.03 inches of water column pressure with externally vented air.
- ISO-Classified Spaces: Containment Secondary Engineering Controls (ISO 7), Biological Safety Cabinets (BSCs), and Containment Aseptic Isolators (CACIs).
- Personnel Protection: PPE protocols, closed-system drug-transfer devices (CSTDs), and routine monitoring.
FTS Cleanrooms specializes in designing negative-pressure cleanrooms with advanced exhaust and airflow control to meet USP 800 standards.
The Path to Compliance
USP 797 and 800 shape the future of pharmaceutical safety. The key to compliance?
- Facility Upgrades: Invest in cleanrooms designed for sterility and containment.
- Staff Training: Ensure best practices in handling sterile and hazardous drugs.
- Technology & Automation: Enhance efficiency while maintaining regulatory compliance.
Looking for expert guidance? FTS Cleanrooms delivers tailored solutions for seamless USP compliance. Contact us today and future-proof your cleanroom for compounding pharmacy facility!
