USP 797 Guidelines: Sterile Compounding Cleanroom Design, Components, and Procedure

USP 797 Guidelines: Sterile Compounding Cleanroom Design, Components, and Procedure

USP 797 Guidelines: Sterile Compounding Cleanroom Design, Components, and Procedure

USP 797 Pharmaceutical Compounding - Positive Pressure Cleanroom Design

United States Pharmacopeia USP 797 took effect on January 1st, 2004 as a regulatory document which outlines procedures and environmental requirements for compounded sterile preparations (CSPs). Favorable outcomes in USP 797 cleanrooms also require proper laminar flow, workstation placement, operator technique, sanitation, and room air cleanliness.

USP 797 expands compounding guidelines for the preparation, storage, and handling of sterile drugs, both hazardous and non-hazardous.

797 Non-Hazardous Cleanroom Design

USP Chapter 797 cleanroom design requires that facilities pressurize non-hazardous compounding and storage areas. ISO 5, 7 and 8 environments support primary engineering controls, buffer rooms, and ante-rooms.

  • ISO Class 5 Primary Engineering Control (external venting not required)
  • ISO Class 7 Positive Pressure Compounding Room
  • ISO Class 8 Positive Pressure Ante Room

Positive pressure ensures that in the case of a breached barrier, the space maintains sterility. Positive pressure rooms allow compounding of TPN (Total Parenteral Nutrition), antibiotic injections, eye-drops, infusion, syringes, salves, oils, and more. A direct compounding area with an ISO Class 5 laminar flow device requires no less than 30 ACH (air changes per hour).

797 Hazardous Cleanroom Design

USP 797 builds upon USP 795 engineering controls. Further, USP 797 requires that hazardous compounding stations be externally vented, be supported by an ISO 7 buffer room, and mandates strict air pressure differentials.

  • ISO Class 5 Primary Engineering Control
  • ISO Class 7 Negative Pressure Buffer Room
  • ISO Class 7 Positive Pressure Ante-Room
  • 0.01″ of Water Column Relative to the Adjacent Area

Negative pressure environments mitigate the risk for harm to both the environment and workers when compounding or packaging antineoplastic drugs, hormonal therapies radiopharmaceuticals, or during the research of pathogens, viruses, and other harmful bacteria.

USP 797 Cleanroom Requirements: Furniture, Ceilings, Walls Floors, and Process Support Equipment

All furniture and materials that enter the area must be non-permeable, non-shedding, cleanable, and resistant to disinfectants. Ceilings, walls, floors, shelving, fixtures, cabinets, pass-throughs, and counters must also support cleaning, be non-shedding, and remain free of cracks and crevices that hinder sanitation.

Cleanrooms have limited space. Factoring in the footprint, ergonomics and aseptic management of various equipment, tools, and furniture requires help from cleanroom design experts. The placement of a sink, bench, storage cabinet or doorway may hinder effectiveness or disrupt laminar flow. The final cleanroom design must consider all essential processes, procedures, and personnel. 

USP 797 Compliance: Gowning, Garbing, and PPE

USP 797 standards require consideration for proper gowning and personal protective equipment (PPE). The requirements may differ based on the State Board of Pharmacy. Some items like gloves, hoods, face masks, bunny suits, and shoe covers require safe and clean-forward disposal after every session. Cleanroom dispensers and receptacle arrangements are essential for throughput and efficient workflow. Less movement means faster task completion and reduced particulate generation.

Automated gowning is popular for facilities with limited space, but also for high-volume facilities. Automatic shoe cover dispensers and removers ease congestions, cut bottlenecks and transfer fewer particulates during the gowning process.

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The content provided is for informational purposes only. It does not constitute a recommendation for your facility or organization. This post serves as a general guideline and summary. At time of publication, the information is in good faith, critically reviewed, and according to the most concurrent information available. Compliance requires temporal evaluation on a case-by-case basis according to state and federal law. The content heirin, linked content, or other web content provided by Production Automation Corporation (PAC) makes no claims as to the final interpretations or implementation of regulatory documents provided by the FDA, State Board of Pharmacy, or United States Pharmacopeia (USP). For this reason, PAC provides on-staff, licensed engineers who are experts in regulatory and application compliance. They are available every business day, toll free (888) 903-0333 for consultation at no cost, no obligation.