ECA-Pre-Conference Workshop Validation of Alternative/Rapid Microbiological Methods
Im Auftrag der ECA Academy

ECA-Pre-Conference Workshop Validation of Alternative/Rapid Microbiological Methods Im Auftrag der ECA Academy

Barcelona, Spain

Seminar Nr. 17842


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Dr Emmanuell Charton, EDQM
Dr Marja Claassen, MSD
Jordi Iglesias Cullell, CRL
Dr Sven M. Deutschmann, Roche
Dr Elena Ferber, Labor LS
Stefan Gärtner, Labor LS
Mike Gajdiss, Lonza
Dr Viviane Grunert da Fonseca, Roche
Peter Huonker, Früh Verpackungstechnik
Dr Pieta IJzerman-Boon, MSD
Dr Michael Miller, Microbiology Consultants LLC
Dr Kai Nesemann, Sartorius
Maria Eugenia Giribets Parra, Boehringer Ingelheim
Dr Wolfgang Rudy, TentaMedix
Dr Michael Ruffing, Boehringer Ingelheim
Alexandra Stärk, Novartis Pharma Stein
Dr Steffanie Strathdee, UCSD Department of Medicine
Dr Ulrich Zuber, Hoffmann-La Roche


In this year’s workshop, different approaches for the validation of alternative microbiological methods will be presented on the basis of case studies by microbiologists and statisticians. In particular, the statistical approach will be considered and subsequently the advantages and disadvantages will be discussed. What were the experiences of the scientists, what solutions were pursued and how was the validation carried out?


In a lecture on the European Pharmacopoeia Chapter 5.1.6, the EDQM defined Alternative Methods for Control of Microbiological Quality:
“The aim is to facilitate the implementation and use of alternative microbiological methods (AMM) where this can lead to cost-effective microbiological control and improved assurance for the quality of pharmaceutical products.
Even if the validation of alternative microbiological methods does not always prove to be easy, especially when it comes to demonstrating comparability with existing compendial methods, implementation in QC laboratories is making progress. It has been found that the collection, analysis and evaluation of the data obtained is of great importance for the validation of alternative and rapid methods. Especially if the results of the alternative methods cannot be presented in the classical cfu, the authority expects “use of statistics to demonstrate equivalency between an alternative and a growth-based compendial method.”
However, there may be different statistical approaches that can be used in the validation process, depending on the method or which microbiological test is affected.


  • Microbiologists from pharmaceutical and biopharmaceutical
  • industry
  • Manufacturer of medical devices
  • Responsible QC/QA staff
  • Experts from contract laboratories
  • Manufacturer and suppliers of BI
  • Responsible Authorities


Alternative methods in the European Pharmacopoeia
Dr Emmanuell Charton, EDQM
  • Relevant texts
  • Current expectations
Non-inferiority testing for RMM validation: Two use cases
Dr Viviane Grunert da Fonseca, Roche Diagnostics
  • Qualitative sterility test: Validation with respect to equivalence
  • Quantitative automated colony counter: Validation with respect to accuracy & precision
Validating a Rapid Sterility Test: Practical Strategies to Ensure Regulatory Compliance
Dr Michael Miller, Microbiology Consultants LLC
  • Review recent regulatory policies and compendial guidance for rapid sterility testing
  • Understand the required validation parameters including limit of detection, specificity, method suitability and equivalence
  • Consider sampling strategies when compendial requirements cannot be met
  • Discuss the impact of short-life products on detection time
  • Debate the need for using stressed microorganisms
  • Provide examples of real-life rapid sterility validation data
Validation Approach for an Alternative Method in Pharmaceutical QC
Dr Marja Claassen & Dr Pieta IJzerman-Boon, MSD
From visual counting to automation of water monitoring with the Growth DirectTM
Maria Eugenia Giribets Parra, Boehringer Ingelheim
  • Build your business case to show the impact of automation in your lab
  • Define your validation strategy: dos and don’ts
  • The Growth DirectTM in routine: benefits and opportunities


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