USP <800> Compounding Cleanrooms

USP 800 is a cleanroom compounding standard that was issued in March of 2014 by the United States Pharmacopeial Convention (USP). It’s primary focus is expanding the safety of healthcare workers, patients, and the environment for processing hazardous drugs. It’s scope reflects a number of stages in the delivery of sterile and non-sterile compounds, including:

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.

How Does USP 800 Change Storage and Unpacking of Hazardous Drugs?

Facilities unpacking hazardous drugs within a negative pressure room do not require procedural changes to meet USP unpacking area requirements. Facilities unpacking HDs within positive pressure ante rooms or facility spaces will require reconsideration.