Published Papers, Posters, and Books
Scott Sutton, Donald Singer - Microbiology best laboratory practices, USP <1117>. Value and recent changes to a guidance of quality laboratory practices - American Pharmaceutical Review, May/June 2011, 41-47
Elaine Kopis Sartain, Jim Polarine - Prevention of microbial contamination. A holistic approach to establishing robust control measures - Pharmaceutical Technology, June 2011, 62-65
Phil Geis, Tony Rook - Microbiological quality of consumer products - happi, May 2011, 82-87
Jerry Lanese - Anatomy of an OOS result - PFQ, May 2011, 30-32
Michael Miller - QbD, PAT, and the future of microbiology - Contract Pharma, May 2011, 70-73
Mark Calmann, Douglas Smith, Tricia Ehmann, Melissa Ruch - Evaluating library databases for microbial ID: Critical aspects and recommendations – PDA Annual Conf., April 2011, Poster
Jeanne Moldenhauer - Proteotypic Identification methods - A change in Identification methods - American Pharmaceutical Review, April 2011, 34-37
Oliver Gordon, Jennifer Gray, Hans-Joachim Anders, Alexandra Staerk, Oliver Schlaefli - Overview of rapid microbiological methods evaluated, validated and implemented for microbiological quality control - European Pharmaceutical Review, April 2011
James Agalloco, James Akers - Revisiting interventions in aseptic processing - Pharmaceutical Technology April 2011, 69-72
Scott Sutton - Successful microbiological investigations - American Pharmaceutical Review, March 2011, 34-42
Barbara Potts - Adventitious agent control and regulations of raw materials used in biopharmaceutical manufacturing - American Pharmaceutical Review, March 2011, 75-79
Kalavati Suvarna, Anastasia Lolas, Patricia Hughes, Richard Friedman - Case studies of microbial contamination in biologic product manufacturing - American Pharmaceutical Review, Jan./Feb. 2011, 50-56
James Akers, James Agalloco, Madhu Raju Saghee - Scientific aspects of aseptic processing - Pharma Times, October 2010
Jennifer Gray, Alexandra Staerk, Manfred Bertchtold, Manuel Mercier, Gunther Neuhaus, Andreas Wirth - Introduction of a Rapid Microbiological Method as an alternative to the Pharmacopeial method for the sterility test - American Pharmaceutical Review, 88-94, October 2010
Mario Hellings, Tom Van den Kerkhof, Jeroens Geens, Steve Mehrman - Applying PAT in pharmaceutical processes - European Pharmaceutical Review, 14-17, October 2010
Jeanne Moldenhauer - Use of a viability test method. Does it mean what you think? - American Pharmaceutical Review, August 2010
Angel Salaman-Byron - Bioburden method suitability for cleaning and sanitation monitoring: How far do we have to go? - Pharmaceutical Technology, August 2010, Vol 34, issue 8
Dawn McIver - Using RMM for environmental monitoring. RMMs can also be used for air and surface monitoring, with modest regulatory resistance - Pharma Manufacturing, August 2010
Tim Sandle - Selection of active air samplers - The Journal, Institute of Sciences and Technology, Summer 2010, pp25-31
Jennifer Gray, Alexandra Staerk, Manfred Bertchtold, Werner Hecker, Gunther Neuhaus, Andreas Wirth - Growth-promoting properties of different solid nutrient media evaluated with stressed and unstressed microorganisms - PDA Journal, May/June 2010, 64:249-263
Luis Jimenez, Narendra Rana, Kasey Travers, Verce Tolomanoska, Kimberly Walker - Evaluation of the Endosafe Portable Testing System for the rapid analysis of biopharmaceutical samples - PDA Journal, May 2010
Claudio Denoya, Edwin Dawson, Darwin Sessoms, Michael Baumstein, John Shabushnig - A rapid microbiological assay to monitor the effectiveness of a vaccine injector sanitization following a microbial challenge procedure - American Pharmaceutical Review, April 2010
John Duguid - Top 10 validation considerations when implementing a rapid Mycoplasma test - American Pharmaceutical Review, April 2010
Kevin Williams - The BET as a backdrop for establishing PAT and RMM goals - American Pharmaceutical Review, December 2009
Gavin Halbert - The weakest link is getting stronger - European Pharmaceutical Review, December 2009
Frances DeGrazio - Extractables & leachables testing for drug packaging - Contract Pharma, November 2009
Babur Chowdhry, Saima Jabeen, Bruce Alexander - Raman spectroscopy in pharmaceutical analysis - European Pharmaceutical Review, October 2009
Stephen Langille, Lynne Ensor, David Hussong - Quality by design for pharmaceutical microbiology - American Pharmaceutical Review, September 2009
Michael Miller – It’s time to get rapid – PDA Letter, April 2009
Pascal Yvon – Rapid Microbio ROI. Calculating scientific benefits as return on investment dollars – Pharmaceutical Formulation and Quality, June 2009
Michael Miller – Breaking the rapid microbiological method financial barrier: a case study – BioPharm International, September 2009
Eric Bagur – Current evaluation of both compendia and rapid methods (ATP Bioluminescence) for monitoring water quality in pharmaceutical manufacturing – European Pharmaceutical Review, 2009
Gilberto Dalmaso – Qualification of high-recovery, flocked swabs as compared to traditional rayon swabs for microbiological environmental monitoring of surfaces – PDA Journal, June 2008
William Fleming – Rapid microbiology: what is truly possible? – American Pharmaceutical Review, December 2008
Jeanne Moldenhauer - A case for regulatory guidelines for verifying automated microbiological methods - American Pharmaceutical Review, July/August 2008
Steven Richter - Pharmaceutical sterility testing: essential things to know - Contract pharma, March 2008
Hans-Joachim Anders, Marion Keller, Manfred Berchtold, Werner Hecker - Polyphasic approach to microbial identification - American Pharmaceutical Review, Nov./Dec. 2007.
Luis Jimenez - Microbial Diversity in Pharmaceutical Product Recalls and Environments - PDA Journal of Pharmaceutical Science and Technology, Volume 61, Number 5, September-October 2007.
Phil Geis - Fundamental elements of cosmetic and OTC drug microbiological quality - American Pharmaceutical Review, May/June 2007
Pascal Yvon - Automation justification - Pharmaceutical Formulation & Quality - May 2007
Maosheng Yao, Gediminas Mainelis - Analysis of portable impactor performance for enumeration of viable bioaerosols - Journal of Occupational and Environmental Hygiene, 2007
John Broad, Barbara Kanegsberg - Minimizing viable and non-viable contamination: standards and guidance for medical device manufacturers - Controlled environments, September 2007
Phil Geis - Fundamental elements of cosmetic and OTC drug microbiological quality - American Pharmaceutical Review, May 2007
Angel Salaman-Byron - Implementation of microbial EM program for non-aseptic pharmaceutical processes - American Pharmaceutical Review, July/August 2006
Anthony Cundell - Microbial identification strategies in the pharmaceutical - PDA Journal, March/April 2006.
James Oliver - The viable but nonculturable state in bacteria - The Journal of Microbiology, February 2005
Michel Drancourt - 16S ribosomal DNA sequence analysis of a large collection of environmental and clinical unidentifiable bacterial isolates - Journal of Clinical Microbiology, October 2000
