Article CommentaryCommentary
Challenges Encountered in the Implementation of Bio-Fluorescent Particle Counting Systems as a Routine Microbial Monitoring Tool
Allison Scott, Ans Vanbroekhoven, Cedric Joossen, Chris Knutsen, David Govezensky, Hans-Joachim Anders, James Cannon, Joanny Salvas, Michael Dingle, Patrick Hutchins, Petra Merker, Philip Villari, Stephanie Ramsey, Anthony Cundell, Victoria Navarro and Margit Franz-Riethdorf
PDA Journal of Pharmaceutical Science and Technology January 2023, 77 (1) 2-9; DOI: https://doi.org/10.5731/pdajpst.2021.012726
Allison Scott
1PEMM/Azbil North America Research and Development: BioVigilant, 2005 W. Ruthrauff Rd. #151, Tucson, AZ 85705;
Ans Vanbroekhoven
2BioPhorum/Sanofi, Cipalstraat 8, 2440 Geel, Belgium;
Cedric Joossen
3OWBA/Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium;
Chris Knutsen
4BioPhorum/Bristol-Myers Squibb, New Brunswick, NJ;
David Govezensky
5BioPhorum/Bio-Technology General (Israel) Ltd., POB 571, Be'er Tuvia Industrial Zone, Kiryat Malachi 8310402, Israel;
Hans-Joachim Anders
6OWBA/Novartis Pharma Stein AG, Schaffhauserstrasse 101, 4332 Stein, Switzerland;
James Cannon
7PEMM/Mettler-Toledo Thornton, Inc., 900 Middlesex Turnpike, Building 8, Billerica, MA 01821;
Joanny Salvas
8BioPhorum/Pfizer, Kirkland, Quebec, Canada;
Michael Dingle
9PEMM/TSI Incorporated, 500 Cardigan Road, Shoreview, MN 55126;
Patrick Hutchins
9PEMM/TSI Incorporated, 500 Cardigan Road, Shoreview, MN 55126;
Petra Merker
10BioPhorum/Bayer AG, Müllerstr. 178, D-13353 Berlin, Germany;
Philip Villari
11BioPhorum/PEMM/Merck & Co., Inc., Kenilworth, NJ;
Stephanie Ramsey
12BioPhorum/Amgen, Inc., One Amgen Center Dr., Thousand Oaks, CA 91320;
Anthony Cundell
13PEMM/Microbiological Consulting, LLC., 105 Lee Rd, Scarsdale, NY 10583;
Victoria Navarro
14BioPhorum/Pfizer, S. S. de los Reyes, Madrid, Spain; and
Margit Franz-Riethdorf
15BioPhorum Operations Group Limited, 5 Westbrook Court, Sharrowvale Road, Sheffield, S11 8YZ, United Kingdom
References
- 1.↵
- 2.↵
- Irie K.,
- Scott A.,
- Hasegawa N.
- 3.↵
- Miller M. J.,
- Lindsay H.,
- Valverde-Ventura R.,
- O'Conner M. J.
- 4.↵
- Cundell A.,
- Gordon O.,
- Haycocks N.,
- Johnston J.,
- Luebke M.,
- Lewis N.,
- Mateffy J.,
- Weber J.-W.
- 5.↵
- Moldenhauer J.
- 6.↵
- 7.↵U.S. Food and Drug Administration. Guidance for Industry PAT –A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance. Center for Drug Evaluation and Research, U.S. Department of Health and Human Services: Rockville, MD, 2004.
- 8.↵
- Scott A.,
- Forng R.-Y.,
- Russ M.,
- Dalmaso G.,
- Hooper S.,
- Villari P.,
- Cannon J.,
- Francis J.,
- Dingle M.
- 9.↵
- Weber J.,
- Hauschild J.,
- IJzerman-Boon P.,
- Forng R.-Y.,
- Horsch J.,
- Yan L.,
- Prasad A.,
- Henry R.,
- Claassen M.,
- Villari P.,
- Shereefa S.,
- Wyatt J.,
- Bolden J. S.,
- Pycke J.-T.,
- Dassu D.
- 10.↵
- Prasad A.,
- Scott A.,
- Manzer D.,
- Weber J.,
- Chen J.-P.,
- Lawson L.,
- Dingle M.,
- Noverini P.,
- Villari P.,
- Hooper S.
- 11.↵
- Anders H.-J.,
- Ayers F.,
- Fitch B.,
- Forng R.-Y.,
- Hooper S.,
- Luebke M.,
- Mateffy J.,
- Noverini P.,
- Termine B.,
- Yan L.,
- Weber J.
- 12.↵Online Water Bioburden Analyzer Workgroup. A Better Approach to Pharmaceutical Water Testing – User Requirements for an Online Water Bioburden Analyzer. Pharm. Online [Online] 2018. https://www.pharmaceuticalonline.com/doc/a-better-approach-to-pharmaceutical-water-testing-user-requirements-for-an-online-water-bioburden-analyzer-0001 (accessed June 27, 2021).
- 13.↵
- Prasad A.,
- Villari P.,
- Henry R.,
- Weber J.,
- Hauschild J.,
- Yan L.,
- Horsch J.,
- Shereefa S.,
- Rau J. E.,
- Milling A.,
- Bolden J. S.,
- Plourde L.,
- Claassen M.,
- IJzerman-Boon P.,
- Forng R.-Y.,
- Portmann R.,
- Urwyler S.,
- Dassu D.
- 14.↵
- Epstein S. S.
- 15.↵U.S. Pharmacopeial Convention. General Chapter <1223> Validation of Alternative Microbiological Methods. In USP 38–NF 33, USP: Rockville, MD, 2015.
- 16.↵European Commission, EudraLex—The Rules Governing Medicinal Product in the European Union, Volume 4: Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Annex 1: Manufacture of Sterile Medicinal Products. European Commission: Brussels, 2010.
- 17.↵European Commission. Second Targeted Stakeholders' Consultation on the Draft Revision 12 of Annex 1, on Manufacturing of Sterile Medicinal Products, of Eudralex Volume 4. https://ec.europa.eu/health/medicinal_products/consultations/2020_sterile_medicinal_products_en (accessed August 15, 2021)
- 18.↵
- Hussong D.,
- Mello R.
- 19.↵
- Cundell T.
- 20.↵Parenteral Drug Association Inc. Technical Report No. 33: Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Methods; Bethesda, MD, 2013.
- 21.↵Council of Europe, Alternative Methods for Control of Microbiological Quality, Chapter 5.1.6. In European Pharmacopoeia (Phar. Eur.), Council of Europe: Strasbourg, France, 2015.
- 22.↵
- Miller M. J.
- 23.↵U.S. Pharmacopeial Convention. General Chapter <1223> Validation of Alternative Microbiological Methods. In USP 29–NF 24, Suppl. 2, USP: Rockville, MD, 2006; p 3807.
- 24.↵U.S. Pharmacopeial Convention. General Chapter <1223> Validation of Alternative Microbiological Methods. In USP 37–NF 32, USP: Rockville, MD, 2014; p 1152.
- 25.↵Parenteral Drug Association. Technical Report 33 Evaluation, Validation and Implementation of New Microbiological Testing Methods. PDA J. Pharm. Sci. Technol. 2000, 54 (3, Suppl).
- 26.↵Council of Europe. Alternative Methods for Control of Microbiological Quality, Chapter 5.1.6, In European Pharmacopoeia (Ph. Eur.), Council of Europe: Strasbourg, France, 2006.
- 27.↵
- Montenegro-Alvarado J.-M.
- 28.↵
- Montenegro-Alvarado J.-M.,
- Salvas J.,
- Weber J.,
- Mejias S.,
- Arroyo R.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 77, Issue 1
January/February 2023
Challenges Encountered in the Implementation of Bio-Fluorescent Particle Counting Systems as a Routine Microbial Monitoring Tool
Allison Scott, Ans Vanbroekhoven, Cedric Joossen, Chris Knutsen, David Govezensky, Hans-Joachim Anders, James Cannon, Joanny Salvas, Michael Dingle, Patrick Hutchins, Petra Merker, Philip Villari, Stephanie Ramsey, Anthony Cundell, Victoria Navarro, Margit Franz-Riethdorf
PDA Journal of Pharmaceutical Science and Technology Jan 2023, 77 (1) 2-9; DOI: 10.5731/pdajpst.2021.012726
Challenges Encountered in the Implementation of Bio-Fluorescent Particle Counting Systems as a Routine Microbial Monitoring Tool
Allison Scott, Ans Vanbroekhoven, Cedric Joossen, Chris Knutsen, David Govezensky, Hans-Joachim Anders, James Cannon, Joanny Salvas, Michael Dingle, Patrick Hutchins, Petra Merker, Philip Villari, Stephanie Ramsey, Anthony Cundell, Victoria Navarro, Margit Franz-Riethdorf
PDA Journal of Pharmaceutical Science and Technology Jan 2023, 77 (1) 2-9; DOI: 10.5731/pdajpst.2021.012726
Jump to section
Related Articles
- No related articles found.
Cited By...
- No citing articles found.
More in this TOC Section
Similar Articles
Keywords