United States Pharmacopoeia (USP) Chapter 797 “Pharmaceutical Compounding – Sterile Preparations”. What is it?

USP 797 was established to have enforceable, detailed procedures and requirements for compounding sterile preparations. Although California has not fully adopted this as a requirement, it is highly recommended to adhere to the guidelines set forth in USP 797 as a standard for operation. The USP 797 regulation is endorsed by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). USP 797 was designed to reduce or prevent harm to patients resulting from contamination of Compounded Sterile Preparations (CSP’s)

CEPA Company provides the routine testing and sampling required to meet USP 797. Testing of your Cleanroom, including Viable and Non-Viable air sampling, Airflow and Air volume measurement, Room pressurization, Filter integrity testing as well as testing of all your types of Primary Engineering Controls (PEC’s). Biological Safety Cabinets (BSC’s), Laminar Air Flow Work Stations (LAFW’s), Compounding Aseptic Isolators (CAI’s), Compounding Aseptic Containment Isolators (CACI’s).


What do I need to do to become USP 797 compliant?

(CSP’s) must be manipulated within an ISO Class 5 PEC. Either a LAFW, CAI, CACI or other unidirectional ISO 5 space.
Cleanroom must meet ISO Classification for cleanliness
Cleanroom must have HEPA filtered air
Cleanroom should be constructed of materials to allow for proper cleaning and sanitization
Implementation of an Airborne Viable Monitoring Schedule and Evaluation