TY - JOUR T1 - The Development of a Microbial Challenge Test with <em>Acholeplasma laidlawii</em> To Rate Mycoplasma-Retentive Filters by Filter Manufacturers JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol SP - 281 LP - 296 DO - 10.5731/pdajpst.2014.00976 VL - 68 IS - 3 AU - Martha Folmsbee AU - Kerry Roche Lentine AU - Christine Wright AU - Gerhard Haake AU - Leesa Mcburnie AU - Dilip Ashtekar AU - Brian Beck AU - Nick Hutchison AU - Laura Okhio-Seaman AU - Barbara Potts AU - Vinayak Pawar AU - Helena Windsor Y1 - 2014/05/01 UR - http://journal.pda.org/content/68/3/281.abstract N2 - 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. ER -