title: Microbial retention characteristics of 0.2-microns-rated nylon membrane filters during filtration of high viscosity fluids at high differential pressure and varied temperatures.
abstract: Regulatory guidelines for aseptic manufacture of pharmaceuticals recommend validation of sterilizing filters by bacterial challenge under "worst case" conditions. The microbial retention characteristics of a sterilizing grade, 0.2-microns-rated Nylon 66 membrane filter were evaluated for filtration of high viscosity fluids. Glycerol (80%) was used as the carrier fluid and Pseudomonas diminuta ATCC 19146 as the challenge organism. Testing was carried out at a constant differential pressure of 60 psig over a six-hour test period. Test runs were undertaken at three different temperature conditions (25 +/- 5 degrees C, 42 +/- 1 degree C, and 50 +/- 1 degree C). Under the test conditions, the Nylon 66 membranes provided total retention of P. diminuta. The results demonstrated that a high pressure differential challenge using a high viscosity fluid over a six-hour test period at ambient and elevated temperatures did not alter the retention characteristics of the membrane filter.
authors.affiliation: Pall Corporation, Port Washington, New York, USA.
authors.forename: H
authors.initials: H
authors.lastname: Aranha
authors.forename: J
authors.initials: J
authors.lastname: Meeker
mesh_terms: D008567:Membranes, Artificial; D009757:Nylons; D011312:Pressure; D011549:Pseudomonas; D013242:Sterilization / Q000295:instrumentation*; D013696:Temperature; D014462:Ultrafiltration / Q000295:instrumentation*; D014783:Viscosity
chemical_list: D008567:Membranes, Artificial; D009757:Nylons