Wednesday, 26 January 2011
Pharmaceutical membrane filter validation guide
Membrane filters play a critical role in providing sterile air and gases in pharmaceutical, biotechnology and containment applications. The filters must be proficient in removing airborne viruses (bacteriophage) and spores from large volumes of moist air/gas streams over prolonged periods. This validation guide describes the results of testing Fluorofil cartridges under the approved protocol ASTM F838-05, a rigorous test for evaluating the bacterial retention characteristics of membrane filters used to sterilise liquids.
The test data confirmed that standard production Fluorofil filter cartridges will retain very high challenge levels of the industry standard test organism Brevundimonas diminuta. To demonstrate sterilisation capabilities in a dry gas process, the Fluorofil filters were challenged with aerosolised phage, as demonstrated using MS-2 coliphage and aerosols of non-vegetative spores, as demonstrated using spores of Bacillus atrophaeus.
Further information is provided to show all components used in the Fluorofil filter cartridge are non-toxic and biologically inert to comply with USP Class VI - 121OC and Code of Federal Regulations (CFR), Title 21. Fluorofil filter cartridges are also demonstrated to retain integrity after repeated steaming in place cycles (SIP). Data is provided to demonstrate the high performance liquid flow and air flow characteristics of Fluorofil membrane cartridges.
Fluorofil cartridges utilise the inherently hydrophobic expanded polytetrafluoroethylene (ePTFE) membrane, which provides the highest levels of biosecurity throughout the process industry. When combined with quality all-polypropylene components and high integrity manufacturing techniques, the Fluorofil filter cartridge is ideally suited to the most demanding process conditions.
Fluorofil cartridges are constructed in an ISO Class 5 clean room under tightly controlled conditions using advanced, highly specialised machinery. Quality and consistency of product are assured by the quality control and manufacturing procedures, which are in place throughout all stages of manufacture. Each module of every Fluorofil™PTFE membrane cartridge is 100% integrity tested during manufacture by the forward flow diffusion method.
A copy of the Fluorofil Membrane Cartridge Validation is available from www.porvairfiltration.com