RT Journal Article
SR Electronic
T1 Microbial Retention Characteristics of 0.2-µm-rated Nylon Membrane Filters during Filtration of High Viscosity Fluids at High Differential Pressure and Varied Temperatures
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 67
OP 70
VO 49
IS 2
A1 Aranha, H.
A1 Meeker, J.
YR 1995
UL http://journal.pda.org/content/49/2/67.abstract
AB 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-µm-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°C, 42 ± 1°C, and 50 ± 1°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.