USP797 USP800 Cleanroom

USP797 USP800 Cleanroom

USP797 USP800 Cleanroom Manufacturer, Supplier & Exporter

Manufacturing high integrity USP797 USP800 Cleanroom in Mumbai-India

Purchase USP797 USP800 Cleanroom at Best Cost

USP797 USP800 Cleanroom

Axenic system is based in Mumbai-India; we are established manufacturer, supplier and exporter in this clean room business. To make your products not affected or contaminated by environment is one of the three pillars we set our company on. Because of this, we developed turn-key solutions for industries like yours who require the most stringent specification in clean and sterile environments.

Experienced : professional Turnkey Complete Cleanrooms, Modular Cleanrooms, Modular Hard wall clean Rooms, Modular Softwall Clean Rooms, Modular Dry Clean room or Dry Cleanroom, LEED Cleanroom, Medical Device Cleanrooms, USP797 USP800 Cleanroom, Cleanroom Ceilings design, manufacturing, installation and certification since 2000. We had built more than 100 cleanrooms. Axenic System Quality construction: We manufacture all our components in house. Installation is done by our factory team. We will design, manufacture and install a custom cleanroom based on your application.

Axenic system know about the cleanroom requirements of USP797 USP800 Cleanroom for compounding and filling rooms

It's our pleasure to help your pharmacy meet the requirements.
  • Wipe down Pharmacy cleanrooms
    • New modular construction
    • Upgrade existing room to cleanroom
    • Gowning room / airlock
    • Pass Thru's
    • Cleanroom certification
  • Custom Class 100 cleanroom benches
  • Cleanroom cabinets and tables
  • Pass Thru's
  • Cleanroom certification
Within USP 797 classification 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 applied to all persons who prepare CSPs and all places where CSPs are prepared including physicians' offices.

The USP 797 cleanroom requirements are usual 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.

Axenic System 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 affiliation 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.

USP800 rules propose changes handling hazardous drugs (HD) that affect cleanrooms:
  • Require negative pressure rooms and BSC
  • Signs and de-marketing lines warning of hazard
  • Labeling requirements
  • Storage requirements
  • Pass thru requirements