Research ArticleResearch
Evaluation of a Rapid Microbiological Method with a Mixed Culture Biofilm Model
Patrick J. McCormick, Michael J. Schoene, Matthew A. Dehmler, James J. Kaiser, Susan E. Norton, Alexandre Pizon and Mark A. Fornalik
PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 512-532; DOI: https://doi.org/10.5731/pdajpst.2013.00932
Patrick J. McCormick
Bausch and Lomb, Inc., Rochester, NY, USA, and Labege, France
Michael J. Schoene
Bausch and Lomb, Inc., Rochester, NY, USA, and Labege, France
Matthew A. Dehmler
Bausch and Lomb, Inc., Rochester, NY, USA, and Labege, France
James J. Kaiser
Bausch and Lomb, Inc., Rochester, NY, USA, and Labege, France
Susan E. Norton
Bausch and Lomb, Inc., Rochester, NY, USA, and Labege, France
Alexandre Pizon
Bausch and Lomb, Inc., Rochester, NY, USA, and Labege, France
Mark A. Fornalik
Bausch and Lomb, Inc., Rochester, NY, USA, and Labege, France

References
- 1.↵
- Miller M.J.
- Miller M. J.
- 2.↵
- Miller M. J.
- 3.↵
- Miller M. J.
- Bierman C.
- 4.↵
PDA Technical Report 33. Evaluation, validation, and implementation of new microbiological testing methods. J. Parent. Sci. Technol. 2000, 54 (3).
- 5.↵
USP. Chapter 1223. Validation of Alternative Microbiological Methods. In United States Pharmacopeia; U.S. Pharmacopeial Convention: Rockville, MD, 2012; pp 873–875.
- 6.↵
Ph. Eur. Chapter 5.1.6. Alternative Methods for Control of Microbiological Quality. In European Pharmacopeia; Council of Europe: Strasburg, France, 2009; pp 532–543.
- 7.↵
- Miller M. J.
- London R.,
- Schwedock J.,
- Sage A.,
- Michalek M.,
- Valley H.,
- Lacirigonla J.,
- Welter P.,
- Jimenez L.,
- Buhl S.,
- Straus D.
- 8.↵
- Miller M. J.
- Ohresser S.
- 9.↵
- Miller M. J.
- Yvon P.
- 10.↵
- Donlan R. W.,
- Costeron W. J.
- 11.↵
- Bridier A.,
- Briandet R.,
- Thomas V.,
- Dubois-Brissonnet F.
- 12.↵
- Costerton J. W.,
- Lewandoski Z.,
- Caldwell D. E.,
- Korber D. R.,
- Lappin-Scott H. M.
- 13.↵
- McCormick K.
- 14.↵
- Flemming H. C.,
- Geesey G. G.
- Mittelmann M. W.
- 15.↵
Guide to Inspections of High Purity Water Systems. Retrieved April 5, 2013 from http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074905.htm.
- 16.↵
- Clontz L.,
- Wagner C. M.
- Fornalik M.
- 17.↵
- Williams K. L.
- Haberer K.
- 18.↵
ISO 11989-8:2006/Amd 1:2011. Ophthalmic implants—intraocular lenses—Part 8: Fundamental requirements. Amendment 1.
- 19.↵
- Bradshaw D. J.
- 20.↵
- Yao Y.,
- Sturdevant D. E.,
- Otto M.
- 21.↵
- Shemesh M.,
- Tam A.,
- Steinberg D.
- 22.↵
Guidance for Industry. Validation of growth-based rapid microbiological methods for sterility testing of cellular and gene therapy products. Center for Biologics Evaluation and Research, U.S. Food and Drug Aministration, 2008.
- 23.↵
- Chavez de Paz L. E.,
- Hamilton I. R.,
- Svensäter G.
- 24.↵
- Battin T. J.
- 25.↵
- Shams A.,
- Rose L. J.,
- Hodges L.,
- Arduino. M. J.
- 26.↵
- McBain A. J.
- 27.↵
- 28.↵
- 29.↵
- Lau Y. L.,
- Liu D.
- 30.↵
USP. Chapter 1231. Water for Pharmaceutical Purposes. United States Pharmacopeia, 35th ed.; U.S. Pharmacopeial Convention: Rockville, MD, 2012; p 5231.
- 31.↵
- Niemira B. A.,
- Solomon E. B.
- 32.↵
- 33.↵
- 34.↵
- 35.↵
- Costanzo S. P.,
- Borazjani R. N.,
- McCormick P. J.
- 36.↵
- Jones D. L.,
- Brailsford M. A.,
- Drocourt J.-L.
- 37.↵
- Jacobs A.,
- Chenia H. Y.
- 38.↵
- 39.↵
ISO 21527-2:2009. Microbiology of food and animal feeding stuffs—Horizontal method for the enumeration of yeasts and moulds—Part 2: Colony count technique in products with water activity less than or equal to 0.95.
- 40.↵
USP. Chapter 1227. Validation of Microbial Recovery. United States Pharmacopeia; U.S. Pharmacopeial Convention: Rockville, MD, 2012; pp 883–884.
- 41.↵
- Sutton S.
- 42.↵
- Smith R.,
- Von Tress M.,
- Tubb C.,
- Vanhaecke E.
- 43.↵
- 44.↵
- Gapp G.,
- Guyomard S.,
- Nabel P.,
- Scouvart J.
- 45.↵
- Miller M. J.
- McDaniel A.
- 46.↵
- Vanhee L. M. E.,
- Nelis H. J.,
- Coenye T.
- 47.↵
- Baudart J.,
- Coallier J.,
- Laurent P.,
- Prevost M.
- 48.↵
- Parthuisot N.,
- Binet M.,
- Touron-Bodilis A.,
- Pougnard C.,
- Lebaron P.,
- Baudart J.
- 49.↵
- 50.↵
- Pitts B.,
- Hamilton M. A.,
- Zelver N.,
- Stewart P. S.
- 51.↵
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 67, Issue 5
September/October 2013
Evaluation of a Rapid Microbiological Method with a Mixed Culture Biofilm Model
Patrick J. McCormick, Michael J. Schoene, Matthew A. Dehmler, James J. Kaiser, Susan E. Norton, Alexandre Pizon, Mark A. Fornalik
PDA Journal of Pharmaceutical Science and Technology Sep 2013, 67 (5) 512-532; DOI: 10.5731/pdajpst.2013.00932
Evaluation of a Rapid Microbiological Method with a Mixed Culture Biofilm Model
Patrick J. McCormick, Michael J. Schoene, Matthew A. Dehmler, James J. Kaiser, Susan E. Norton, Alexandre Pizon, Mark A. Fornalik
PDA Journal of Pharmaceutical Science and Technology Sep 2013, 67 (5) 512-532; DOI: 10.5731/pdajpst.2013.00932
Jump to section
Related Articles
- No related articles found.