The process validation of cartridge filters specific to a product is mandatory in the pharmaceutical industry to ensure compliance with standards set by regulatory authorities including the United States FDA, European Pharmacopeia and ISO 13408-2.
Porvair’s sterile filter range is 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, standardised 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.
New recommendations
Porvair, in collaboration with FDA approved laboratories, is now offering to 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 company says that its in-process validation service is lower cost than those being offered by other leading cartridge filter manufacturers.
“It is our intention to remove the cost barrier validation has historically presented, to allow customers the freedom to select our products for their process,” said market manager Mike Hughes. “We believe that our product- and process specific validation service provides considerable peace of mind, going above and beyond standardised tests, and promoting new levels of assurance.”
