Q: Auditors have requested test data to confirm that wipers used by a cleanroom consumables distributor are non-linting. Is this a requirement of USP 797?
A: Yes. The 2008 revision bulletin of The United States Pharmacopeial (USP) Convention states: “All cleaning materials, such as wipers, sponges, and mops shall be nonshedding, preferably composed of synthetic micro fibers, and dedicated to use in the buffer or clean area, ante-area, and segregated compounding areas and shall not be removed from these areas except for disposal.” The auditors were requiring validation documentation that the wipers in use were “non-shedding” or non-linting. The documented evidence is the particle contamination level data generated by the wiper manufacturer that is entered on the Certificate of Analysis accompanying each lot of wipers manufactured.
