Porvair Filtration Group, a provider of filtration and separation products, offers validation services for its polymeric and disposable cartridge filters for a range of pharmaceutical manufacturing processes.
The cartridge filters are designed and manufactured in accordance with international standards for the safe application into pharmaceutical processes, depending on specific project requirements. These include filter compatibility assessments, bacterial challenge testing, extractable analysis, adsorption studies and product wetted integrity test studies.
All validation studies take into account the critical parameters and worst-case conditions of a particular manufacturing process; adhering to the standards and guidelines established by regulatory authorities (FDA and EU), as well as the recommendations of the Parenteral Drug Association’s Technical Report No26 “Sterilizing Filtration of Liquids.”
Equipped with state-of-the-art facilities, Porvair and their partner laboratories simulate the process conditions and carry out physio-chemical and microbiological studies to meet and exceed the standards required by regulatory authorities. Studies at partner laboratories are carried out under the umbrella of strict Good Laboratory Practice (GLP) guidelines to ensure data integrity.
Porvair demonstrates bacterial retention and acceptable extractables in actual process conditions. Its validation experience encompasses a range of injectable products and manufacturing processes, including antibiotics, vitamins, aggressive-solvent and oil-based formulations. Working with independent laboratories allows Porvair to guarantee that the highest GLP standards are met, and customers are assured that data integrity and quality are safeguarded by a facility with many years’ experience of providing analytical support in the pharmaceutical sector.