Encyclopedia of Rapid Microbiol Methods, Volume 4

Table of Contents:

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• Foreword by Bryan S. Riley

1. The Application of Modern Microbial Methods to the Quality Control Testing of Probiotics by Anthony M. Cundell
2. Considerations for Choosing a Rapid Microbiological Method: Aligning Your Needs with Available Technology by Julie Schwedock
3. Looking to the Future: Rapid and Automated Microbial Identification Technologies by Michael J. Miller, Ph.D.
4. Use of MALDI-TOF Mass Spectrometry for Microbiological Identification in the Pharmaceutical Industry by Lothar Bomblies
5. Implementation of a Genotypic Method for Microbial Identification by Sara Gamberini and Emiliano Toso
6. Microbial Identification Using the bioMerieux VITEK^® 2 System — An Update by David H. Pincus
7. Case Study of a New Growth-Based Rapid Microbiological Method that Detects the Presence of Specific Organisms and Provides an Estimation of Viable Cell Count by Ruth Eden and Roger Brideau
8. Evaluation of the Millipore Milliflex^® Quantum Rapid Detection System: An Internal Study of a Novel Rapid Method for Microbial Detection in Traditional Membrane Filtration Bioburden Assays by Eric J. Ward
9. Application of USP <1223> and Other Guidelines to Comprehensively Assess an Environmental Monitoring RMM for Validation by Scott Morris
10. Evaluation of the BioVigilant IMD-A^™, A Novel Optical Spectroscopy Technology for the Continuous and Real-time Environmental Monitoring of Viable and Nonviable Particles. Part 1. Review of the Technology and Comparative Studies with Conventional Methods by Michael J. Miller, Horatio Lindsay, Rene Valverde-Ventura, and Michael J. O'Conner
11. Evaluation of the BioVigilant IMD-A^™, A Novel Optical Spectroscopy Technology for the Continuous and Real-time Environmental Monitoring of Viable and Nonviable Particles. Part 2. Case Studies in Environmental Monitoring During Aseptic Filling, Intervention Assessments, and Glove Integrity Testing in Manufacturing Isolators by Michael J. Miller, Michael R. Walsh, Jerry L. Shrake, Randall E. Dukes, and Daniel B. Hill
12. A Rapid Microbiological Method for the Release Testing of Sterile And Non-Sterile Products by Alessio Fantuzzi
13. Validation of the Bact/Alert^® Microbial Detection System as an Alternate Rapid Sterility Test for Dendreon Active Cellular Immunotherapy Products by Timothy D. Wood
14. Rapid Method for Microbiological Quality Control to Obtain Same Day Results: A Validation Approach by Ir Peter Cornelis
15. Feasibility Studies on Rapid Sterility Testing Using a Bioluminescence-based Method by Claudio Denoya, Jennifer Reyes, Maitry Ganatra, and Daniel Eshete
16. Statistics of Validating an Alternate Sterility Test: Limits of Detection and Other Problems by Julie Schwedock
17. Validation of SECOND Generation ATP Monitoring Technology for Rapid Microbiological Quantification in Fluid Applications by David R. Tracey, Patrick A. Whalen, and James E. Cairns
18. Detection of Specified Microorganisms in Drug Formulations Using A New Quantitative Polymerase Chain Reaction (qPCR) System with Preloaded Multi-well Discs by Daniel Eshete, Maitry Ganatra, and Claudio Denoya
19. Mycoplasma Testing: Overview, Detection and Validation by Fabrizio Lecce, Fabio La Neve, Federica Gillone, and Emiliano Toso
20. A Microarray for Mycoplasma Detection and Identification: Cytolnspect^™ by Annett Kilic and Jorg Stappert
21. Rapid Viral Methods (RVM) for Biological Quality Control (BQC) by Laura Barberis and Emiliano Toso
22. Rapid Microbiological Methods and New Pharmaceutical Microbiology Curriculum by Claudio D. Denoya
23. Application of Rapid Microbiological Methods in BioProcessing and Regulatory Considerations by Anastasia G. Lolas

About the Editor

Dr. Michael J. Miller is an internationally recognized microbiologist and subject matter expert in pharmaceutical microbiology and the design, validation and implementation of rapid microbiological methods. He is currently the President of Microbiology Consultants, LLC. Dr. Miller consults with multinational companies in providing technical, quality and regulatory solutions in support of RMMs, sterile and non-sterile pharmaceutical manufacturing, contamination control, isolator technology, validation and microbiological PAT. He also provides comprehensive training for his clients in the areas of rapid method validation and implementation.

Dr. Miller has authored more than 100 technical publications and presentations in the areas of rapid microbiological methods, PAT, ophthalmics, disinfection and sterilization, is the editor of PDA's Encyclopedia of Rapid Microbiological Methods. He currently serves on the editorial and review boards for European Pharmaceutical Review, American Pharmaceutical Review, and the PDA Journal of Science and Technology. Dr. Miller is also co-chairing the revision of PDA Technical Report #33: Evaluation, Validation and Implementation of New Microbiological Testing Methods, and routinely provides RMM training programs for the industry and professional organizations worldwide. Dr. Miller was appointed the John Henry Hobart Fellow in Residence for Ethics and Social Justice, awarded PDA's Distinguished Service Award and was named Microbiologist of the Year by the Institute of Validation Technology (IVT).