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. The new 2011 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.
To demonstrate sterilisation capabilities in a dry gas process, data is provided showing how 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. The methods and protocols for sampling and challenge testing were carried out in accordance with the Parenteral Drug Association Technical Report 40 Sterilizing Filtration of Gases guidelines.
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 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.
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 Filtration Group 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.
For a copy of the 2011 Fluorofil Validation Guide please click here.