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Research ArticleTechnology/Application

The Development of a Microbial Challenge Test with Acholeplasma laidlawii To Rate Mycoplasma-Retentive Filters by Filter Manufacturers

Martha Folmsbee, Kerry Roche Lentine, Christine Wright, Gerhard Haake, Leesa Mcburnie, Dilip Ashtekar, Brian Beck, Nick Hutchison, Laura Okhio-Seaman, Barbara Potts, Vinayak Pawar and Helena Windsor
PDA Journal of Pharmaceutical Science and Technology May 2014, 68 (3) 281-296; DOI: https://doi.org/10.5731/pdajpst.2014.00976
Martha Folmsbee
aPall Corporation, Port Washington, NY;
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  • For correspondence: Martha_folmsbee@pall.com
Kerry Roche Lentine
bEMD Millipore, Billerica, MA;
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Christine Wright
bEMD Millipore, Billerica, MA;
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Gerhard Haake
cSartorius Stedim Biotech GmbH, Göttingen, Germany;
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Leesa Mcburnie
dMeissner Filtration Products, Inc. Camarillo, CA;
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Dilip Ashtekar
ePAREXEL International, Upland, CA;
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Brian Beck
fMicrobiologics, St. Cloud, MN;
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Nick Hutchison
gParker Hannifin Manufacturing Ltd, Durham, United Kingdom;
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Laura Okhio-Seaman
hSartorius Stedim Biotech, Bohemia, NY;
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Barbara Potts
iFDA, Silver Spring, MD; and
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Vinayak Pawar
jMycoplasma Experience, Reigate, Surrey, United Kingdom
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Helena Windsor
aPall Corporation, Port Washington, NY;
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Abstract

Mycoplasma are bacteria that can penetrate 0.2 and 0.22 μm rated sterilizing-grade filters and even some 0.1 μm rated filters. Primary applications for mycoplasma filtration include large scale mammalian and bacterial cell culture media and serum filtration. The Parenteral Drug Association recognized the absence of standard industry test parameters for testing and classifying 0.1 μm rated filters for mycoplasma clearance and formed a task force to formulate consensus test parameters. The task force established some test parameters by common agreement, based upon general industry practices, without the need for additional testing. However, the culture medium and incubation conditions, for generating test mycoplasma cells, varied from filter company to filter company and was recognized as a serious gap by the task force. Standardization of the culture medium and incubation conditions required collaborative testing in both commercial filter company laboratories and in an Independent laboratory (Table I). The use of consensus test parameters will facilitate the ultimate cross-industry goal of standardization of 0.1 μm filter claims for mycoplasma clearance. However, it is still important to recognize filter performance will depend on the actual conditions of use. Therefore end users should consider, using a risk-based approach, whether process-specific evaluation of filter performance may be warranted for their application.

LAY ABSTRACT: Mycoplasma are small bacteria that have the ability to penetrate sterilizing-grade filters. Filtration of large-scale mammalian and bacterial cell culture media is an example of an industry process where effective filtration of mycoplasma is required. The Parenteral Drug Association recognized the absence of industry standard test parameters for evaluating mycoplasma clearance filters by filter manufacturers and formed a task force to formulate such a consensus among manufacturers. The use of standardized test parameters by filter manufacturers, including the preparation of the culture broth, will facilitate the end user's evaluation of the mycoplasma clearance claims provided by filter vendors. However, it is still important to recognize filter performance will depend on the actual conditions of use; therefore end users should consider, using a risk-based approach, whether process-specific evaluation of filter performance may be warranted for their application.

  • © PDA, Inc. 2014
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PDA Journal of Pharmaceutical Science and Technology: 68 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 68, Issue 3
May/June 2014
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The Development of a Microbial Challenge Test with Acholeplasma laidlawii To Rate Mycoplasma-Retentive Filters by Filter Manufacturers
Martha Folmsbee, Kerry Roche Lentine, Christine Wright, Gerhard Haake, Leesa Mcburnie, Dilip Ashtekar, Brian Beck, Nick Hutchison, Laura Okhio-Seaman, Barbara Potts, Vinayak Pawar, Helena Windsor
PDA Journal of Pharmaceutical Science and Technology May 2014, 68 (3) 281-296; DOI: 10.5731/pdajpst.2014.00976

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The Development of a Microbial Challenge Test with Acholeplasma laidlawii To Rate Mycoplasma-Retentive Filters by Filter Manufacturers
Martha Folmsbee, Kerry Roche Lentine, Christine Wright, Gerhard Haake, Leesa Mcburnie, Dilip Ashtekar, Brian Beck, Nick Hutchison, Laura Okhio-Seaman, Barbara Potts, Vinayak Pawar, Helena Windsor
PDA Journal of Pharmaceutical Science and Technology May 2014, 68 (3) 281-296; DOI: 10.5731/pdajpst.2014.00976
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