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;
Kerry Roche Lentine
bEMD Millipore, Billerica, MA;
Christine Wright
bEMD Millipore, Billerica, MA;
Gerhard Haake
cSartorius Stedim Biotech GmbH, Göttingen, Germany;
Leesa Mcburnie
dMeissner Filtration Products, Inc. Camarillo, CA;
Dilip Ashtekar
ePAREXEL International, Upland, CA;
Brian Beck
fMicrobiologics, St. Cloud, MN;
Nick Hutchison
gParker Hannifin Manufacturing Ltd, Durham, United Kingdom;
Laura Okhio-Seaman
hSartorius Stedim Biotech, Bohemia, NY;
Barbara Potts
iFDA, Silver Spring, MD; and
Vinayak Pawar
jMycoplasma Experience, Reigate, Surrey, United Kingdom
Helena Windsor
aPall Corporation, Port Washington, NY;

References
- 1.↵
- Maniloff J.,
- McElhaney N.,
- Finch L.,
- Baseman J.
- 2.↵
- Hayflick L.
- 3.↵
- Molander C. W.,
- Kagan B. M.,
- Weinberger H. J.,
- Heimlich E. M.,
- Busser R. J.
- 4.↵
- 5.↵
- 6.↵
- Rottem S.
- 7.↵
- Saito Y.,
- McElhaney R. N.
- 8.↵
- Folmsbee M.,
- Noah C.,
- McAlister M.
- 9.↵
- 10.↵
- Razin S.,
- Tourtellotte M. E.,
- McElhaney R. N.,
- Pollack J. D.
- 11.↵
- Rottem S.,
- Panos C.
- 12.↵
- McElhaney R. N.,
- Tourtellotte M. E.
- 13.↵
- 14.↵
- 15.↵
- Rilfors L.,
- Wikander G.,
- Wieslander A.
- 16.↵
- Wieslander A.,
- Nordstrom S.,
- Dahlqvist A.,
- Rilfors L.,
- Lindblom G.
- 17.↵
- Lindblom G.,
- Hauksson J. B.,
- Rilfors L.,
- Bergenstahl B.,
- Wieslander A.,
- Eriksson P. O.
- 18.↵
- 19.↵
- Bates S.,
- Nguyen N.,
- Lentine K. R.
- 20.↵
- Krantz M.,
- Nordlander B.,
- Valadi H.,
- Johansson M.,
- Gustafsson L.,
- Hohmann S.
- 21.↵
- Jenkins D. E.,
- Chaisson S. A.,
- Matin A.
- 22.↵
- Kjelleberg S.
- 23.↵
- Weart R. B.,
- Lee A. H.,
- Chien A. C.,
- Haeusser D. P.,
- Hill N. S.,
- Levin P. A.
- 24.↵
- Givskov M.,
- Eberl L.,
- Moller S.,
- Poulsen L. K.,
- Molin S.
- 25.↵
- Velimirov B.
- 26.↵
- Brown M. R.,
- Williams P.
- 27.↵
- 28.↵
- McElwain M. C.,
- Williams M. V.,
- Pollack J. D.
- 29.↵
- Cronholm K.,
- Bates S.,
- Nguyen N.,
- Leahy A.,
- Blanchard M.,
- Lentine K. R.
- 30.↵
- 31.↵
- Drexler H. G.,
- Uphoff C. C.
- 32.↵
- Potts B.
- 33.↵
ASTM. Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration American Society for Testing and Materials (ASTM) 2013, ASTM Standard F838–05 (Reapproved 2013).
- 34.↵
PDA. PDA Technical Report No 26, Sterilizing Filtration of Liquids. PDA J Pharm Sci Technol. 2008, 62 (S-5), 1–60.
- 35.↵
Food and Drug Administration (FDA) Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice. FDA: Rockville, MD, 2004.
- 36.↵
The Rules Governing Medicinal Products in the European Union. Volume 4. Medicinal Products for Human and Veterinary Use: Good Manufacturing Practices Annex 1 Manufacture of sterile Medicinal Products. Belgium, 2003.
- 37.↵
Aseptic Processing of Health Care Products—Part 2: Filtration. In ISO 13408-2:2003(E), Standardization. Geneva, Switzerland, 2003.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 68, Issue 3
May/June 2014
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
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
Jump to section
Related Articles
- No related articles found.