USP 797 Guidelines: Sterile Compounding Cleanroom Design, Components, and Procedure

USP Chapter 797 cleanroom design requires that facilities pressurize non-hazardous compounding and storage areas. ISO 5, 7 and 8 environments support primary engineering controls, buffer rooms, and ante-rooms.

Upgrading a USP 797 Cleanroom to USP 800?

USP 800 cleanroom upgrades - ISO 5 with ISO 7 Buffer room

New USP guidelines may present challenges for compounding facilities. Some facilities need infrastructural and mechanical modifications for compliance. System evaluation includes duct systems, HEPA fan filters, differential pressure standards, air monitoring, and external air exhaust equipment.