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Pharmaceutical Membrane Filter Validation Guide
Porvair Filtration Group, a world leader in filtration and separation technologies, has developed a new 24-page validation guide for its FluorofilTM membrane cartridges.
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 FluorofilTM 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 FluorofilTM 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 FluorofilTM 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 FluorofilTM filter cartridge are non-toxic and biologically inert to comply with USP Class VI - 121OC and Code of Federal Regulations (CFR), Title 21. FluorofilTM 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 FluorofilTM membrane cartridges.
Porvair Filtration Group (Microfiltrex division) has specifically designed FluorofilTM membrane cartridges, for use in the pharmaceutical industry and other critical applications. FluorofilTM 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 FluorofilTM filter cartridge is ideally suited to the most demanding process conditions.
FluorofilTM 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 FluorofilTM PTFE membrane cartridge is 100% integrity tested during manufacture by the forward flow diffusion method.
A copy of the FluorofilTM Membrane Cartridge Validation is available from www.porvairfiltration.com or by contacting Porvair Filtration Group on +44-1489-864330 / +1-804-550-1600 or email email@example.com.
Filtration and separation processes in the pharmaceutical industry are critical, not only to ensure products are adequately purified and fit for consumption, but also to optimise process economics and prevent loss of valuable product. Porvair has over 25 years experience in providing innovative solutions that meet the customer's requirements as well as standards set by the regulatory authorities. Manufacturing of their high performance, cost effective products is underpinned by their quality assurance programme, cGMP practices and clean room environment to ensure products meet the stringent requirements of the Pharmaceutical, Generics and Veterinary Medicines industry.
Porvair Filtration Group is an international leader in the development and supply of materials and products for applications in filtration and separation. Their expertise in a wide range of media and the dedication of their design, manufacturing, sales, test and research teams ensure they are at the forefront of filtration technology, delivering world class performance to the Aerospace, Defence, Nuclear, Energy, Chemical Process, Industrial Process, Water Treatment, Printing and Life Science markets. With offices and manufacturing sites located in the UK, Europe and the USA combined with a world-wide network of market representatives and distributors, they pride themselves on their continuous innovation and research to meet global demands.