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Research ArticleRESEARCH

Method For Qualifying Microbial Removal Performance of 0.1 Micron Rated Filters PART IV: Retention of Hydrogenophaga pseudoflava (ATCC 700892) and Ralstonia pickettii (ATCC 700591) by 0.2 and 0.22 μm Rated Filters

Srikanth Sundaram, Michelle Lewis, Jean Eisenhuth, Glenn Howard and Bob Larson
PDA Journal of Pharmaceutical Science and Technology May 2002, 56 (3) 150-171;
Srikanth Sundaram
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  • For correspondence: Sri_Sundaram@pall.com
Michelle Lewis
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Jean Eisenhuth
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Glenn Howard Jr.
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Bob Larson
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Abstract

Ralstonia pickettii has emerged as a bioburden microorganism of considerable importance in pharmaceutical processes utilizing conventional 0.2 or 0.22 μm rated “sterilizing grade” filters. In this article, we re-evaluated and studied the retention efficiencies of 0.2 μm rated nylon 6,6 and 0.22 μm rated modified polyvinylidene fluoride (PVDF) filters for Hydrogenophaga pseudoflava (ATCC 700892) and R. pickettii (ATCC 700591). Out of a total of forty-four 0.2/0.22 μm rated filters discs tested in this study (spanning different challenge fluids, different challenge conditions, and different filter types), H. pseudoflava penetration was observed for every filter disc tested. Log titer reduction (LTR) values ranged from 0.3 to 2.0 logs for 20-48 hour challenges conducted in Water for Injection (WFI), and 3.8-7.1 logs for 6-hour challenges conducted in Minimal Media Davis (MMD). For 0.2 μm nylon 6,6 filter discs, penetration by R. pickettii was observed only in WFI challenges and was dependent on the culture and challenge conditions used. Penetration by R. pickettii was also restricted to only those membrane discs that were very close to the filter manufacturer's production integrity test (the Quantitative Bubble Point, QBP, test) limit. Where R. pickettii penetration was observed, LTR values were significantly higher than those observed for H. pseudoflava with the same filter discs. This study: 1) supports the use of H. pseudoflava as a worst-case challenge model for R. pickettii in process- and product-specific bacterial retention testing; 2) provides experimental evidence, for the first time, for the need to include filter membrane lots that have a physical integrity test value at or near the filter manufacturer's production (lower) limit in these tests; and 3) demonstrates how a standardized membrane integrity test (such as the QBP test) can be used select such “worst-case” membranes and to verify the inclusion of such “worst-case” membranes in these tests, thus serving as the link between the membrane disc used in bacterial retention validation testing and the production process filter.

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PDA Journal of Pharmaceutical Science and Technology
Vol. 56, Issue 3
May/June 2002
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Method For Qualifying Microbial Removal Performance of 0.1 Micron Rated Filters PART IV: Retention of Hydrogenophaga pseudoflava (ATCC 700892) and Ralstonia pickettii (ATCC 700591) by 0.2 and 0.22 μm Rated Filters
Srikanth Sundaram, Michelle Lewis, Jean Eisenhuth, Glenn Howard, Bob Larson
PDA Journal of Pharmaceutical Science and Technology May 2002, 56 (3) 150-171;
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Cited By...

  • Benchmarking of Sterilizing-Grade Filter Membranes with Liposome Filtration
  • Comparative Analysis of Bacterial Community Composition and Structure in Clinically Symptomatic and Asymptomatic Central Venous Catheters
  • 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
  • The Importance of Accurate Microorganism Identification in Microbial Challenge Tests of Membrane Filters. Part II. The Comparison of Hydrogenophaga pseudoflava ATTC 33668 and Curvibacter sp. ATCC 700892 by Microbial Challenge Tests with Membrane Filters
  • Sterilizing Filtration of Liposome and Related Lipid-Containing Solutions: Enhancing Successful Filter Qualification
  • The Importance of Accurate Microorganism Identification in Microbial Challenge Tests of Membrane Filters--Part I
  • Use of Hydrogenophaga pseudoflava Penetration To Quantitatively Assess the Impact of Filtration Parameters for 0.2-Micrometer-Pore-Size Filters
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  • A Proof-of-Concept Study on a Universal Standard Kit to Evaluate the Risks of Inspectors for Their Foundational Ability of Visual Inspection of Injectable Drug Products
  • Quantitative and Qualitative Evaluation of Microorganism Profile Identified in Bioburden Analysis in a Biopharmaceutical Facility in Brazil: Criteria for Classification and Management of Results
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Method For Qualifying Microbial Removal Performance of 0.1 Micron Rated Filters PART IV: Retention of Hydrogenophaga pseudoflava (ATCC 700892) and Ralstonia pickettii (ATCC 700591) by 0.2 and 0.22 μm Rated Filters
Srikanth Sundaram, Michelle Lewis, Jean Eisenhuth, Glenn Howard, Bob Larson
PDA Journal of Pharmaceutical Science and Technology May 2002, 56 (3) 150-171;

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