Usp 797 Clean Room Humidity Requirements

Install hepa filters in ceiling fans.

Usp 797 clean room humidity requirements.

If the c sec for sterile compounding is a c sca the c sec should be externally vented. To meet the updated usp 797 requirements photo courtesy of r c. The following discussion describes considerations for functional operation of the suite cleanroom design usp requirements and basic hvac principles that must be carefully melded together to design and build a usp 797 suite that can be certified as compliant. It describes a number of requirements including responsibilities of compounding personnel training environmental monitoring.

Iso classification of particulate matter in room air particles 0 5 µm and larger per cubic meter iso class particle count 3 35 2 4 352 5 3 520 6 35 200 7 352 000 8 3 520 000. Inside the room and in which other relevant parameters e g temperature humidity and pressure are controlled as necessary it is critical to understand how your pharmacy cleanroom is impacted by the myriad of standards and references for cleanroom de sign and operation including usp chapter 797 require. Usp 797 clean room guidelines standards portafab specializes in the turn key design and construction of modular clean rooms including applications specifically requiring usp 797 compliance. And be at negative pressure between 0 01 and 0 03 inches of water.

Replace floors with seamless vinyl flooring. Favorable outcomes in usp 797 cleanrooms also require proper laminar flow workstation placement operator technique sanitation and room air cleanliness. Implement a web based software system to ensure usp 797 compliance. Replace non compliant ceiling tiles with clean room grade tiles.

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. Adopt usp 797 facility engineering clean room guidelines.