USP797 USP800 Cleanroom

American Cleanroom Systems® is knowledgeable about cleanroom requirements for USP797 USP 800 for compounding and filling rooms.

Due to the differing State Board of Pharmacy regulations in each state, American Cleanroom Systems® only builds USP797 USP 800 cleanrooms in Southern California.

  • Wipe down Pharmacy cleanrooms
    • New modular construction
    • Upgrade existing room to cleanroom
    • Gowning room / airlock
  • Custom Class 100 cleanroom benches
  • Cleanroom cabinets and tables
  • Pass Thru’s
  • Cleanroom certification

Under USP 797 regulation compounding pharmacies are required to compound sterile preparations (CSPs) utilizing a laminar flow workstation within a clean room. Sterile compounding is classified into 3 risk groups: Low Risk, Medium Risk, and High Risk. If your institution prepares CSPs, which meet the definition of the specific categories, described in USP Chapter 797 you must comply with USP 797. The standards are intended to apply to all persons who prepare CSPs and all places where CSPs are prepared including physicians offices.

The USP 797 cleanroom requirements are general in nature, but refer to the International Standards Organization ISO-14644 standards for cleanrooms. To achieve USP 797 compliance, pharmacies must perform sterile drug compounding within an ISO 5 (Class 100) hood environment, enclosed within a larger compounding “Buffer Zone” of ISO 7 (Class 10,000) positive pressure controlled-air environment (Cleanroom). The ISO 5 compounding environment can be maintained utilizing a Laminar Flow Work Station within an ISO 7 cleanroom. Maintaining the proper pressure within the cleanroom must be evaluated and taken into consideration when designing and balancing the overall sterile environment. To be in compliance with USP-797, the cleanroom design also needs to meet the criteria for the risk level of protection for sterile compounding. American Cleanroom Systems® offers a variety of controlled environment solutions to meet the USP 797 compounding regulations.

American Cleanroom Systems® prefabricated, non-shedding, modular clean room walls meet the USP 797 regulations and can be designed as a totally freestanding self-contained room or in conjunction with existing walls. Modular wall panels made of FRP (reinforced plastic) and HPL (high pressure laminate) are used most often in pharmaceutical, USP 797 compounding rooms, and medical device clean rooms. These panels can withstand repeated cleaning and sanitizing without breaking down. American Cleanroom Systems® modular wall system is an economical and cost effective method to achieve the USP 797 requirements.

Some USP800 rules propose changes handling hazardous drugs (HD) that affect cleanrooms:

  • Require negative pressure rooms and BSC
  • Signs and demarcation lines warning of hazard
  • Labeling requirements
  • Storage requirements
  • Pass thru requirements
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