Usp 797 Clean Room Humidity Requirements

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.

Usp 797 clean room humidity requirements.

If the c sec for sterile compounding is a c sca the c sec should be externally vented. 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. To meet the updated usp 797 requirements photo courtesy of r c.

It describes a number of requirements including responsibilities of compounding personnel training environmental monitoring. The iso class 7 ante room or non hd buffer room should maintain a positive pressure of at least 0 02 inches of water column to all adjacent unclassified areas usp 800 2016. Install hepa filters in ceiling fans. And be at negative pressure between 0 01 and 0 03 inches of water.

Ensure that your facility has a modern clean room environment. Replace floors with seamless vinyl flooring. 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.

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. Adopt usp 797 facility engineering clean room guidelines.