Downstream Processing

Integrity Testing Low-Area Filters Using Air–Water Diffusion and an Automatic Integrity Tester

Both FDA and EMEA guidelines require integrity testing of filters used in processing sterile solutions such as large- and small-volume parenterals (LVPs and SVPs). The same regulatory agencies also require that corresponding test documentation be included with batch product records. PRODUCT FOCUS: PARENTERALSPROCESS FOCUS: DOWNSTREAM PROCESSING, SCALE-UPWHO SHOULD READ: QA/QC, PROCESS ENGINEERS, AND ANALYTICAL PERSONNELKEYWORDS: FILTRATION, INTEGRITY TESTING, VALIDATION, AUTOMATIONLEVEL: BASIC The function of integrity testing is to determine whether a particular filter is within or outside the validated specifications…