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Encyclopedia of Rapid Microbiological Methods, Volume 4 (Hardcover)

Edited by: Michael Miller

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Rapid microbiological methods have made amazing strides recently and this volume complements Dr. Miller's previous three volumes by offering up-to-the-minute advances, new techniques, case studies, new equipment and much more.

Contents of the Encyclopedia of Rapid Microbiological Methods, Volume 4 include details about: quality control, choosing appropriate methods, future use and technologies, mass spectrometry, genotypic methods for identification, new case studies, detection, application of USP and other guidelines, environmental monitoring, alternative tests, validation, sterility testing, mycoplasma testing, application of rapid microbiological methods as they relate to both bio-processing and regulatory considerations, many product-specific method advances and much, much more.

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Table of Contents:

Click here to download >>>Table of Contents

  • 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

"Modern approaches to process control (including Process Analytical Technology) require the availability of results in real-time (or at least close to real-time) to enable the operator to use the test results to make process decisions and adjustments. These current rapid microbiological test methods are now able to start providing some of the advantages (from a process control and economic return standpoint) long enjoyed by our colleagues in the clinical and food microbiology labs. Pharmaceutical microbiologists would be well served by considering which of their samples would provide a benefit with a more rapid result and then assessing the current alternate microbiological methods to see if any of them are a good fit for their needs. The Encyclopedia of Rapid Microbiological Methods would be an excellent resource to start that assessment."

Bryan S. Riley, Ph.D.
New Drug Microbiology Staff
Office of Pharmaceutical Science, Center for Drug Evaluation and Research
US Food and Drug Administration, Silver Spring, MD, USA

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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).


Date of Publication: January 2013
ISBN Number: 1933722665
Format:
Number of Pages: 608
Binding: Hardcover