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Microbiological Real Time Counting and Testing
13 November 2019
In this course we give an overview of the current requirements, available systems and methods and their areas of application. Speakers from industry, laboratories and manufacturers will report on their experiences and the challenges involved in introducing, establishing and validating real-time test systems.
Microbiological control, whether for environmental monitoring, in-process control or release testing, is mandatory in many cases. In order to be able to react quickly to deviations or to achieve the greatest possible safety for products with a short shelf life, be it ATMP or radiopharmaceuticals, methods for real-time measurement would be desirable. Some of these methods are already available on the market, but they present us with a number of challenges during implementation, e.g:.
- Comparability with Compendial Methods
- Greater sensitivity than previous methods (limit conflict with current requirements)
- Possibility of further cultivation
- Differentiation live/dead
All employees who have to deal with real-time systems, i.e.
- in the laboratory
- in quality control
- during validation
- in the context of inspections or audits
- at regulatory level
Laboratory Services - from Outsourcing to a strategic partnership (Key Note Presentation at the Plenum)
Dr Jürgen Balles, Dr Thomas Meindl and Ingo Grimm, Labor LS
Different Measurement Methods/Systems - Pros and Cons
Annette Kunz, CSL
Implementation of a Microbial Detection Analyzer For Real-Time Monitoring of Microbial Contamination for Purified Water
Natascha Staub, Mibelle
Biofluorescent Particle Counting (BFPC) for continuousmonitoring in aseptic manufacturing
Dr Marja Claassen-Willemse, MSD
Evaluation of the Scanstation 100 system for the automated incubation and analysis of pharmaceutical environmental monitoring samples using standard Petri plates
Diarmaid O’Riordan, Pfizer
Case Study: Using continuous Real-Time intrinsic Fluorescence Techniques for EM in Isolators
Dr Michael Miller, Microbiology Consultants
IMD-W “In-line system for purified water systems” and other decvices for rapid water bioburden analyses
Dr Sven Deutschmann, Roche Diagnostics
Calculating alert levels and trending of microbiological data
Dr David Roesti, Novartis Stein Pharma
New Generation of Solid Phase Cytometry for Rapid Detection of Microbiological Contaminants in Water Samples
Joseph Pierquin, Redberry
Dr Sven M. Deutschmann, Roche Diagnostics
Dr Marja Claassen-Willemse, MSD, The Netherlands
Senior microbiological specialist, Microbiology Center of Excellence.
Dr Sven M. Deutschmann, Roche Diagnostics, Germany
Head of Global ASAT "Adventitious Agents Testing and Alternative Microbiologica. Chairman of the Advisory Board of the ECA “Pharmaceutical Microbiology Interest Group”, Member of PDA Task Forces.
Annette Kunz, CSL Behring, Switzerland
Dr Michael J. Miller, Microbiology Consultants, USA
Global expert in rapid methods, validation and pharmaceutical microbiology.
Diarmaid O’Riordan, Pfizer, Ireland
Joseph Pierquin, Redberry, France
Chief Technical Officer.
Dr David Roesti, Novartis Pharma Stein, Switzerland
Technical Steward Microbiology, Manufacturing Science & Technology.
Natascha Staub, Mibelle, Switzerland