Usp 797 Clean Room Humidity Requirements

To meet the updated usp 797 requirements photo courtesy of r c.

Usp 797 clean room humidity requirements.

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. 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. Replace floors with seamless vinyl flooring. Implement a web based software system to ensure usp 797 compliance.

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. If the c sec for sterile compounding is a c sca the c sec should be externally vented. Standards for compounding sterile preparations usp 797 helps to ensure patients receive quality preparations that are free from contaminants and are consistent in intended identity strength and potency. And be at negative pressure between 0 01 and 0 03 inches of water.

Replace non compliant ceiling tiles with clean room grade tiles. Favorable outcomes in usp 797 cleanrooms also require proper laminar flow workstation placement operator technique sanitation and room air cleanliness. Adopt usp 797 facility engineering clean room guidelines. 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.

It describes a number of requirements including responsibilities of compounding personnel training environmental monitoring. Ensure that your facility has a modern clean room environment.