Usp 797 Clean Room Humidity Requirements

Favorable outcomes in usp 797 cleanrooms also require proper laminar flow workstation placement operator technique sanitation and room air cleanliness.

Usp 797 clean room humidity requirements. 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. 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 non compliant ceiling tiles with clean room grade tiles. 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.

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

Ensure that your facility has a modern clean room environment. 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. If the c sec for sterile compounding is a c sca the c sec should be externally vented. And be at negative pressure between 0 01 and 0 03 inches of water.

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. It describes a number of requirements including responsibilities of compounding personnel training environmental monitoring.