These regulations cover liquid filters used in the manufacture, processing, or packing of injectable drug products intended for human use and state that they must not release fibres into such products. Porvair Filtration Group filters are now safe for the filtration of injectable drug products.
Porvair’s 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. The sterilising grade polymeric filters are fully validated, providing retention of >10,000,000 colony forming units per square centimetre of effective filtration area as stipulated by PDA Technical Report 26.