Integrity Testing
Integrity testing sterilizing filters is a fundamental requirement of critical process filtration applications in the pharmaceutical industry. FDA Guidelines require integrity testing of filters used in the processing sterile solutions such as large volume parenterals (LVPs) and small volume parenterals (SVPs). The FDA also requires corresponding testing documentation be included with batch product records
FDA Guideline 21 Part 11 states all drug products produced using systems with data acquired automatically must conform to the new guidelines that govern the requirements to batch records generated electronically. Today's integrity testers must provide for batch records to include three characteristics including unalterable files, audit trails and electronic signatures.
Two classifications of integrity testing are destructive and nondestructive. Millipore's practice is to perform destructive testing as a lot release criterion on samples from each manufacturing lot of all fabricated sterilizing grade filter products, and nondestructive testing on each sterilizing grade filter prior to sale to insure its integrity.
