Evaluation of the Effect of the Volume Throughput and Maximum Flux of Low-Surface-Tension Fluids on Bacterial Penetration of 0.2 Micron–Rated Filters during Process-Specific Filter Validation Testing

References

1. 1.↵
   PDA Technical Report No. 26. Sterilizing Filtration of Liquids. PDA J. Pharm. Sci. Technol. 2008, 62 (Suppl. 5), 1–60.

   OpenUrlAbstract/FREE Full TextGoogle Scholar
2. 2.↵
   ASTM. Standard test method for determining bacterial retention of membrane filters utilized for liquid filtration. American Society for Testing and Materials 2005, ASTM Standard F838–05.

   Google Scholar
3. 3.↵
   U.S. Food and Drug Administration (FDA). Sterile Drug Products Produced by Aseptic Processing. In FDA Guidance for Industry; FDA: Silver Spring, MD, 2004.

   Google Scholar
4. 4.↵
   1. Onraedt A.,
   2. Folmsbee M.,
   3. Kumar A.,
   4. Martin J.

   Sterilizing filtration of adjuvanted vaccines: ensuring successful filter qualification. BioPharm Intl. Supplements 2010, October 2.

   Google Scholar
5. 5.↵
   1. Sundaram S.,
   2. Lewis M.,
   3. Eisenhuth J.,
   4. Howard G.,
   5. Larson B.

   , Method for qualifying microbial removal performance of 0.1 micron rated filters. Part IV: Retention of Hydrogenophaga pseudoflava (ATCC 700892) and Ralstonia picketti (ATCC700591) by 0.2 and 0.22 micron rated filters. PDA J. Pharm. Sci. Technol. 2002, 56 (3), 150–171.

   OpenUrlAbstract/FREE Full TextGoogle Scholar