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PDA Journal of Pharmaceutical Science and Technology

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Research ArticleResearch

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

Martha Folmsbee
PDA Journal of Pharmaceutical Science and Technology March 2015, 69 (2) 307-316; DOI: https://doi.org/10.5731/pdajpst.2015.01026
Martha Folmsbee
Pall Corporation, 25 Harbor Park Dr., Port Washington, NY
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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 Text
  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.
  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.
  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.
  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 Text
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PDA Journal of Pharmaceutical Science and Technology: 69 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 69, Issue 2
March/April 2015
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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
Martha Folmsbee
PDA Journal of Pharmaceutical Science and Technology Mar 2015, 69 (2) 307-316; DOI: 10.5731/pdajpst.2015.01026

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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
Martha Folmsbee
PDA Journal of Pharmaceutical Science and Technology Mar 2015, 69 (2) 307-316; DOI: 10.5731/pdajpst.2015.01026
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