USP 797/800 CLEANROOMS
A USP 797 cleanroom is a controlled sterile environment required for the compounding of non-hazardous sterile drugs. These cleanrooms comply with the United States Pharmacopeia (USP) Chapter 797, which outlines standards for air quality, cleaning, temperature, humidity, and pressure to ensure patient safety.
USP 797 is a regulation document that outlines procedures and environmental criteria for compounded sterile preparations. It went into force on January 1, 2004. It outlines procedures and environmental requirements for compounded sterile preparations (CSPs). As a top-rated cleanroom manufacturer, we can provide USP 797/800 complaint cleanrooms.
UPS 797/800 compliant cleanrooms require non-unidirectional airflow, a properly arranged workstation layout, guidelines for operator procedures, proper sanitation, and air cleanliness.
Facilities must pressurize non-hazardous compounding and storage spaces according to USP Chapter 797/800 cleanroom design. Primary engineering controls, buffer rooms, and ante-rooms are all supported in ISO 5, 7, and 8 environments.
- Primary Engineering Control (ISO Class 5)
- Positive Pressure Buffer Area (ISO Class 7)
- Positive Pressure Ante Room (ISO Class 8)
Positive pressure ensures that even if a barrier is breached, the region remains sterile. TPN (Total Parenteral Nutrition), antibiotic injections, eye drops, infusions, syringes, salves, oils, and more can all be compounded in positive pressure rooms. At least 30 ACH is required in a direct compounding area with an ISO Class 5 laminar flow equipment (air changes per hour).
