USP 797/USP 800, cGMP Cleaning
USO 797 and 800 are continuing to change and since the previous revision pharmaceutical compounding personnel have been the ones held responsible for the cleanliness of their sterile compounding areas. This includes the cleanliness of the biosafety cabinets (BSCs), compounding aseptic isolators (CAIs), laminar flow benches (LAFWs) and then the buffer areas, anti arears and any other segregated compounding areas.
PMSI can help USP 797 and 800 facilities come up with cleaning schedule and frequency, how to do the proper cleaning, what materials to use based on the certification methods and type of product being compounded. Training is essential based on the protocol that the customer has in place, and must be enforced. It is not enough to expect employees to follow protocols without fully understand why and what they are doing. PMSI can provide the protocols or provide the cleaning itself, in order for the customer to have successful viable and non-viable certifications. More USP 797 and 800 clients fail their certifications due to improper cleaning by their own personnel, and PMSI can help remediate these, and save clients’ money by having one successful certification.