@article {Aranha67, author = {H. Aranha and J. Meeker}, title = {Microbial Retention Characteristics of 0.2-{\textmu}m-rated Nylon Membrane Filters during Filtration of High Viscosity Fluids at High Differential Pressure and Varied Temperatures}, volume = {49}, number = {2}, pages = {67--70}, year = {1995}, publisher = {Parenteral Drug Association (PDA)}, abstract = {Regulatory guidelines for aseptic manufacture of pharmaceuticals recommend validation of sterilizing filters by bacterial challenge under {\textquotedblleft}worst case{\textquotedblright} conditions. The microbial retention characteristics of a sterilizing grade, 0.2-{\textmu}m-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 {\textpm} 5{\textdegree}C, 42 {\textpm} 1{\textdegree}C, and 50 {\textpm} 1{\textdegree}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.}, issn = {0006-3363}, URL = {https://journal.pda.org/content/49/2/67}, eprint = {https://journal.pda.org/content/49/2/67.full.pdf}, journal = {PDA Journal of Pharmaceutical Science and Technology} }