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

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

USP 797 Cleanroom Design

USP 797 Cleanroom Requirements

USP 797 Pharmaceutical Compounding - Positive Pressure Cleanroom Design

United States Pharmacopoeia 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 Chapter <797> expands compounding guidelines for the preparation, storage, and handling of sterile drugs, both hazardous and non-hazardous.

UPS 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).

USP 797 Hazardous Cleanroom Design

While USP 797 previously established requirements for hazardous drug compounding, USP Chapter 800 sets forth new requirements. USP 800 is the latest United States Pharmacopeia (USP) revision which clarifies and expands upon hazardous drug compounding (both sterile and non-sterile). Enhanced engineering and procedural controls extend protection to operators and environments when packaging, handling, and compounding hazardous substances (including 2018 updates to the NIOSH list). USP 797 facilities compounding or handling hazardous drugs may require a number of new concessions including updated equipment, storage, engineering controls, and negative pressure environments. What upgrades does a USP 797 facility require for USP 800 compliance?

  • 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

OR

  • An Equivalent CACI with Respect to Sterile vs Non-Sterile Parameters

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 Hazardous Compounding Updates

While USP 797 previously established requirements for hazardous drug compounding, USP Chapter 800 sets forth new requirements. USP 800 is the latest United States Pharmacopeia (USP) revision which clarifies and expands upon hazardous drug compounding (both sterile and non-sterile). Enhanced engineering and procedural controls extend protection to operators and environments when packaging, handling, and compounding hazardous substances (including 2018 updates to the NIOSH list). USP 797 facilities compounding or handling hazardous drugs may require a number of new concessions including updated equipment, storage, engineering controls, and negative pressure environments. 

What upgrades does a USP 797 facility require for USP 800 compliance?

New USP guidelines may present challenges for compounding facilities. Some facilities need infrastructural and mechanical modifications for compliance. System evaluation includes duct systems, HEPA fan filters, differential pressure standards, air monitoring, and external air exhaust equipment. Learn more.

The newest USP compounding guideline, Chapter 800, clarifies and expands upon the hazardous drug guidelines found in USP 797. USP 800 expands controls for the protection of workers and environments against hazardous drug compounds. In contrast to USP 797, which only remedies sterile compounding activities, USP 800 takes a 360° approach for processing hazardous drugs, both sterile and nonsterile.

Previous to USP 800, USP 797 made some exemptions for small volumes of HDs (hazardous drugs) compounded in a positive pressure room when using a negative pressure laminar flow workstation or compounding aseptic containment isolator (CACI). These exceptions were generally removed by the USP 800 revisions for facilities storing, handling, and processing HDs

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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Disclaimer

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 herein, 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 Pharmacopoeia (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.