Filter integrity testing, from its origins in the 1970s, has undergone significant changes over the last 40 years as industry needs, and the evolution of regulatory expectations have pushed boundaries to reduce risk and increase patient safety. Our founder, Dr Pall, was a pioneer in filter integrity testing, having developed what he referred to as the ‘Forward Flow’ test in 1973. Prior to this and throughout the 1970s filter integrity testing was just a manual bubble point test for a few critical use filters, using a pressure gauge.. These initial manual tests paved the way for the first purpose-built integrity test instruments, developed in the 1980s specifically for the pharmaceutical market. The introduction of FDA guidance and European Good Manufacturing Practice (GMP) (regulators) in 1987 of mandatory integrity testing of critical use filters, accelerated the need for high performance automated test equipment.
By the mid-to-late 90s recommendations for filter integrity testing by the regulatory bodies had expanded. US regulators recommended integrity testing of vent filters in place, and new EU guidelines for GMP were published: Medicinal Products for Human and Veterinary Use (Annex 1) requiring that the integrity of a sterilizing grade filter is tested pre-use and post-sterilization (PUPSIT). This is a subject that still generates some discussion more than 20 years later.
As paper batch records have moved towards electronic, concerns over data integrity have been addressed and improved through Good Automated Manufacturing Practice (GAMP®) guidelines, and increased clarification by the FDA in the form of 21 CFR part 11. Currently, some models of filter integrity test instruments can offer secure data management and data transfer, and confidence that a static filter integrity test result is a true result that cannot be altered.
This guide will help you select the right integrity test instrument, including criteria that will allow accurate filter integrity testing that is fully compliant to current regulations.