title: The Development of a Microbial Challenge Test with Acholeplasma laidlawii To Rate Mycoplasma-Retentive Filters by Filter Manufacturers.
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.
  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.
authors.affiliation: Pall Corporation, Port Washington, NY; Martha_folmsbee@pall.com.
authors.forename: Martha
authors.initials: M
authors.lastname: Folmsbee
authors.affiliation: EMD Millipore, Billerica, MA;
authors.forename: Kerry Roche
authors.initials: KR
authors.lastname: Lentine
authors.affiliation: EMD Millipore, Billerica, MA;
authors.forename: Christine
authors.initials: C
authors.lastname: Wright
authors.affiliation: Sartorius Stedim Biotech GmbH, Göttingen, Germany;
authors.forename: Gerhard
authors.initials: G
authors.lastname: Haake
authors.affiliation: Meissner Filtration Products, Inc. Camarillo, CA;
authors.forename: Leesa
authors.initials: L
authors.lastname: Mcburnie
authors.affiliation: PAREXEL International, Upland, CA;
authors.forename: Dilip
authors.initials: D
authors.lastname: Ashtekar
authors.affiliation: Microbiologics, St. Cloud, MN;
authors.forename: Brian
authors.initials: B
authors.lastname: Beck
authors.affiliation: Parker Hannifin Manufacturing Ltd, Durham, United Kingdom;
authors.forename: Nick
authors.initials: N
authors.lastname: Hutchison
authors.affiliation: Sartorius Stedim Biotech, Bohemia, NY;
authors.forename: Laura
authors.initials: L
authors.lastname: Okhio-Seaman
authors.affiliation: FDA, Silver Spring, MD; and.
authors.forename: Barbara
authors.initials: B
authors.lastname: Potts
authors.affiliation: Mycoplasma Experience, Reigate, Surrey, United Kingdom.
authors.forename: Vinayak
authors.initials: V
authors.lastname: Pawar
authors.affiliation: Pall Corporation, Port Washington, NY;
authors.forename: Helena
authors.initials: H
authors.lastname: Windsor
mesh_terms: D000128:Acholeplasma laidlawii / Q000254:growth & development / Q000302:isolation & purification*; D001431:Bacteriological Techniques / Q000295:instrumentation* / Q000592:standards; D004340:Drug Contamination / Q000517:prevention & control*; D004867:Equipment Design; D005374:Filtration / Q000295:instrumentation* / Q000592:standards; D008851:Micropore Filters / Q000592:standards; D009174:Mycoplasma / Q000254:growth & development / Q000302:isolation & purification*; D010316:Particle Size; D011786:Quality Control; D013997:Time Factors