Porvair Filtration Group has announced that its range of absolute rate filters have been tested for and meet United States Pharmacopeia 788 as well as Federal Drug Administration Title 21, Section 211.72 regulations.
These regulations detail how filters for liquid filtration used in the manufacture, processing, or packing of injectable drug products intended for human use must not release fibres into such products. Unlike some lower cost alternatives this means that Porvair Filtration Group filters have been tested to be safe for the filtration of injectable drug products.
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 our high performance cost effective products is underpinned by Porvair's strict 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 polymeric cartridge filters are constructed from FDA-approved materials carrying the CFR 21 number for biological safety and materials of construction meet USP Class VI-121°C plastics. Designed and manufactured for robustness, our sterilising grade polymeric filters are fully validated providing retention of >107 colony forming units per square centimetre of effective filtration area as stipulated by PDA Technical Report 26.
For further information please contact Porvair Filtration Group on +44-1489-864330 / +1-804-550-1600 or email info@porvairfiltration.com.