RT Journal Article
SR Electronic
T1 Microbial Retention Characteristics of Sterilizing-grade Membrane Filters with Alginate Substituted for Oil-based Products
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 248
OP 254
VO 56
IS 5
A1 So-Hee Lee
A1 Chan-Wha Kim
YR 2002
UL http://journal.pda.org/content/56/5/248.abstract
AB For oil-based products, FDA recommends substitution of the oil with a compound which has similar viscosity and physical characteristics. In this study, a substitute for oil-based products was screened by measuring the viscosity and filterability, and examined for the presence of cell clumps in the various test fluids using an optical microscopy. The viscosity of the test fluids measured in the range of about 60-75 cP. Brevundimonas diminuta (formerly Pseudomonas diminuta), a standard challenge test organism for validation of 0.2 μm rated membrane filters, formed clumps in oils (corn, olive, sesame, and soybean) and polyethylene glycol (PEG, Molecular Weight (MW) = 400 and 1,000). During the viability test, cells suspended in 80% glycerol showed a ten-fold mortality rate after an exposure for 6 hours, but there was no significant change in viability in alginate (low, medium, and high viscosity) for 24 hours. These results suggested that alginate is better suited as a substitute for oil-based products than 80% glycerol. Since high viscosity fluids take longer to filter, the glycerol mortality rate would influence the challenge test negatively. A scaled-down filtration system has been developed for the described trials, and the bacterial challenge and bubble point tests have been performed in 1.6% alginate (66.7 cP), which was the choice of carrier fluid.