Conducting rapid microbiological monitoring in fill-finish with biofluorescent particle counters: a collaborative case study

Mike Dingle is a Senior Product Specialist at TSI where he provides application support for the BioTrak Real-Time Viable Particle Counter and other TSI products used to test and monitor controlled environments. Prior to joining TSI, Mike worked as a QC Microbiologist in the pharmaceutical and medical device industries for over 20 years where he developed and managed environmental monitoring programs for a wide variety of controlled environments.

Ann Carwell is an experienced professional in Life Science and contamination control. Currently, she serves as the National Sales Manager, Contamination Control group with TSI, Inc. Ann’s career started in Pharmaceutical Manufacturing and has had held a variety of Sales and Sales Management roles. She has worked with Pharmaceutical, Diagnostic Manufacturing and Semiconductor customers.



Dr. Michael J. Miller is an internationally recognized microbiologist and subject matter expert in pharmaceutical microbiology, contamination control and the validation of rapid microbiological methods. He is the President of Microbiology Consultants, LLC and owner of http://rapidmicromethods.com, an educational website dedicated to the advancement of rapid microbiological methods.

For more than 35 years, he has held numerous R&D, manufacturing, quality, business development and executive leadership roles at Johnson & Johnson, Eli Lilly and Company, Bausch & Lomb, and his consulting company. In his current role, Dr. Miller advises multinational companies in the areas of microbiology, quality and regulatory affairs in support of rapid methods, sterile and non-sterile pharmaceutical manufacturing and contamination control.

Dr. Miller has authored more than 100 technical publications and presentations and currently serves on the editorial and scientific review boards for American Pharmaceutical Review, European Pharmaceutical Review and the PDA Journal. Dr, Miller is the chairperson for the PDA Technical Report #33 revision: and has served as an advisor to the USP Microbiology Expert Committee in the area of rapid sterility testing.

Dr. Miller holds a Ph.D. in Microbiology and Biochemistry from Georgia State University (GSU), a B.A. in Anthropology and Sociology from Hobart College

Noël Long is a contamination control and sterility assurance professional with in-depth understanding of global regulatory requirements across pharmaceutical, biopharmaceutical, medical device, and healthcare industries. Noël’s experience has focused on aseptic drug product manufacturing and contamination control and reaches across API, cell banking, cell culture, purification, formulation, filtration, aseptic filling, lyophilization, and drug product inspection activities. In her career which includes validation, manufacturing, and quality roles, Noël has held positions of increasing responsibility at Wyeth, GSK, Morphotek, Alexion Pharmaceuticals, GE Healthcare, and Cytiva. Her most recent projects include the airflow visualization studies and biofluorescent particle counter studies for Cytiva’s robotic gloveless filling isolator.