Gas filter technology aims to extinguish pharma fire risk
06/01/2005
EAST HILLS, N.Y.-Fire risk inherent with the production of certain protein-based drugs is the target of a new filtration technology developed by Pall Corp. (www.pall.com), which features specially designed PTFE (polytetrafluoroethylene) materials. The Emflon CPFR sterilizing-grade gas filter has been specifically designed for fermenter or bioreactor applications where potentially hazardous oxygen-enriched air is needed for aeration.
While oxygen enrichment used in protein-based pharmaceuticals improves production yields and lowers overall processing costs, it can also increase fire risk in sterilizing gas filtration operations. Elevated levels of oxygen in bioreactor airflows can spawn spontaneous ignition of conventional air-sterilizing filter materials.
Unlike polypropylene material used in the construction of comparable gas filters, the Emflon’s fire-resistant PTFE material has been complemented with support and drainage layers that have been designed to minimize combustibility. The filter’s technology also has been designed to resist the deteriorating effects of ozonization.
Addressing the PDA 2005 annual meeting this spring in Chicago, Dr. Christian Martin, Pall Life Sciences product manager, claimed, “This is the first filter for the oxygen-enriched aeration of mammalian cell culture and microbial fermentation operations that gives manufacturers a higher degree of safety. It enables drug producers to use modern aeration techniques safely, boosting cell culture yields and enabling a faster level of biotech drug production.”
The Emflon CPFR material has been evaluated by the Federal Institute for Material Research and Testing in Germany, which tests materials designed for gaseous oxygen use. The filter’s materials were subjected to pressure shock tests with 100 percent gaseous oxygen at 145 psi at 140°F. III