High performance filtration and separation specialist Porvair Filtration has introduced a cost-effective, in-process, product validation service for its range of polymeric cartridge filters for use within the pharmaceutical industry.
The company’s polymeric cartridge filters are used in biopharmaceuticals, food and beverage, industrial and chemical process; however, process validation of cartridge filters, specific to a product is mandatory within the pharmaceutical industry to ensure compliance with standards set by regulatory authorities including the United States FDA, European Pharmacopeia and ISO 13408-2.
The sterile filters are already validated to remove bacteria in accordance with the recommendations of leading regulatory and advisory bodies such as HIMA, PDA and ASTM. A detailed validation guide for each product lists the tests undertaken to ensure bacterial retention and USP VI compliance, however, standardized tests do not reflect actual process conditions.
Ingredients used in the manufacture of pharmaceuticals, such as solvents and oils, can degrade filter cartridges; resulting in unacceptably high levels of leachables and extractables, or a compromise in product sterility.
In collaboration with FDA approved laboratories, Porvair Filtration will undertake independent testing for chemical compatibility, extractables, leachables, and bacterial retention. This is in line with the recommendations of the Parenteral Drug Association’s Technical Report 26 ‘Sterilizing Filtration of Liquids’ – the guidelines by which leading manufacturers of pharmaceuticals validate their sterile filtration processes in order to ensure compliance. Porvair Filtration
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