Filtration in the pharmaceutical industry is a readily understood process ranging from clarification of cough syrups and linctuses through to cold sterilisation of heat labile injectable products. Other applications include sterile filtration of air and feedstocks to fermentation processes, filtration of solvents for tabletting processes, tabletting powder handling and recovery systems, sterile filtration of services including water, air and process gases, sterile filtration of ophthalmic solutions and sterile filtration of serum and growth media.
The industry is well regulated and it is important that any filters used in critical applications are fully supported with validation guides. All Porvair Filtration Group membrane filters, supplied to pharmaceutical customers, meet the following internationally recognised standards:
- a minimum retention of >107 cfu/cm2 Brevundimonas diminuta per HIMA methodology
- manufactured from non-toxic materials of construction, including o-rings and seals
- non-fibre releasing
- integrity testable by end-user
- traceable identification number
- manufactured in a clean room environment with a recognised quality system
In addition, our membrane filters have been validated using an independent testing laboratory, covering the following critical tests:
- bacterial challenge tests
- materials of construction (FDA CFR numbers)
- USP toxicity tests
- MEM elution tests
- limulus test
- physicochemical test
- sterilisation by in-line steam
- sterilisation by hot water
Our validated filters used in the pharmaceutical industry include, BiofilTM II, BiofilTM Plus, FluorofilTM, FluorofilTM Plus, PolyfilTM, KlearfilTM and MicrofilTM GP.
Please contact a Porvair Filtration Group company representative for further information and advice on our complete range of filtration solutions for the pharmaceutical industry, and our design and manufacturing services.