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Microbiological Real Time Counting and Testing

13 November 2019

Objectives

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.

Background

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

Target Audience

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