Language selection: PharmaLab Kongress - Switch to the German version of the website DE | PharmaLab Congress - English version of the websiteEN

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

Programme

Different Measurement Methods/Systems - Pros and Cons
Annette Kunz, CSL

Implementation of a Real Time System of Mettler Toledo
Natascha Staub, Mibelle

Automated Colony Counting
Dr Jan Erik Rau, Lonza
t.b.a, Lonza

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

Experiences at Roche – Water/EM?
t.b.a.

Monitoring/Trending
Dr David Roesti, Novartis

New Generation of Solid Phase Cytometry for Rapid Detection of Microbiological Contaminants in Water Samples
Joseph Pierquin, Redberry

Speakers

Annette Kunz, CSL Behring
Manager Monitoring.

Dr Sunhee Hong, Charles River Microbial Solutions, USA
Microbial Solutions R&D Senior Staff Scientist.

Dr Michael J. Miller, Microbiology Consultants, USA
Global expert in rapid methods, validation and pharmaceutical microbiology.

Diarmaid O’Riordan, Pfizer
QC Microbiologist.

Joseph Pierquin, Redberry
Chief Technical Officer.

Dr Jan Erik Rau, Lonza
Head of QC Microbiology.

Natascha Staub, Mibelle
Microbiological QC.

Dr David Roesti, Novartis Pharma Stein
Technical Steward Microbiology, Manufacturing Science&Technology.