Usp 797 Clean Room Humidity Requirements

Ensure that your facility has a modern clean room environment.

Usp 797 clean room humidity requirements.

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. Replace non compliant ceiling tiles with clean room grade tiles. And be at negative pressure between 0 01 and 0 03 inches of water. 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. Replace floors with seamless vinyl flooring. Adopt usp 797 facility engineering clean room guidelines. 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.

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. If the c sec for sterile compounding is a c sca the c sec should be externally vented. Implement a web based software system to ensure usp 797 compliance.

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. Install hepa filters in ceiling fans.