Press Release Summary:
Available for polymeric cartridge filters used within pharmaceutical industry, in-process Product Validation Service ensures compliance with standards set by regulatory authorities including U.S. FDA, European Pharmacopeia, and ISO 13408-2. Company will provide independent testing for chemical compatibility, extractables, leachables, and bacterial retention. This is in line with recommendations of Parenteral Drug Association’s Technical Report 26 'Sterilizing Filtration of Liquids'.
Original Press Release:
Filtration Specialist Unveils Product Validation Service
An international leader in high performance filtration and separation has introduced a cost-effective, in-process, product validation service for its range of polymeric cartridge filters for use within the pharmaceutical industry.
Porvair Filtration Group’s range of polymeric cartridge filters are used across many markets including 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.
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.
Porvair Filtration, in collaboration with leading FDA approved laboratories, is 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 guidelines by which leading manufacturers of pharmaceuticals validate their sterile filtration processes in order to ensure compliance.
Offered as an additional service rather than expressly for commercial profit, Porvair’s in-process validation service is lower cost than those being offered by other leading cartridge filter manufacturers. In addition, Porvair Filtration Group is able to offer customers this service via a number of payment plans based on the customer’s individual requirements.
Market Manager Mike Hughes states: “Porvair is proud to be driving higher standards whilst bringing down costs in this important area. 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. 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. It represents another step forward as we continue to strive to widen our offering with best value and innovation in mind, and look forward to introducing users to the benefits.”