European Microbiology Conference

26/27 June 2024


  • Pharmacopoeial Developments – From alternative Testing and Modern Methods
  • Contamination Control – Monitoring, Disinfection and more
  • Method Validation and Interpretation of Results
  • Monitoring – Challenges with Temperatures and more
  • Endotoxin and Pyrogen – USP, Ph.Eur. and Chinese Pharmacopoeia
  • Bioindicators


The role of pharmaceutical microbiology is getting more and more important. The microbial control concept is increasingly in the focus of regulators during product submission and inspections. Current challenges are Endotoxin-masking effects (“Low Endotoxin Recovery” implementation of alternative microbiological methods, control of cell- based products and ongoing issues with contamination control – there were an increasing number of findings in the authority reports.

The challenge is therefore to satisfy regulatory requirements alongside management’s financial expectations.

Target Audience

This conference is of interest to professionals in microbiology from

  • Pharmaceuticals and Biopharmaceutical Companies
  • Academic Research Institutions
  • Government Agencies
  • Contract Laboratories

who are involved in

  • Contamination Control
  • Monitoring
  • Validation
  • Quality Affairs
  • Regulatory Affairs
  • Research and Development


Dr Sven M. Deutschmann
Roche, Chair of the ECA Pharmaceutical Microbiology Working Group

Axel Schroeder
Administration Manager, Pharmaceutical Microbiology Working Group


Overview and Future Plans of the USP Rapid Microbiological Methods Subcommittee
Dr David Roesti, Novartis

  • General overview of the RMM chapters under drafting
  • General principles of the revised <72> and <73> chapters
  • Drafting and reviewing process within the USP microbiology expert committee

Revision of Technical Report 33 – Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Methods
Dr Michael Miller, Microbiology Consultants

  • Understand what’s new in the 2024 Technical Report and how it compares with current regulatory and pharmacopoeia guidance
  • Review new recommendations for validation and statistical analysis
  • Provide instruction on how to apply the guidance for short-life products and ATMPs

Remediation of Contaminated Protein A Chromatography Resin: Case Studies from Biophorum Members
Robin De Scheemaeker, Sanofi & Jacob Sonne-Hansen, Fujifilm

  • General overview of the challenges associated with protein A chromatography resins necessitate the development of effective sanitization approaches capable of addressing routine maintenance and responding to bacterial contamination events.
  • Review of case studies from different Biophorum members:
    - Sanofi Case study: Upscaling a Peracetic Acid cleaning method for protein A chromatography resin for application as a non-routine cleaning method involving PAA solution to remediate a column contamination.
    - Other Biophorum case studies - TBD

Use of Physics-Methods for Contamination Control (Space-Charge Electret / Nanoflashing)  
Jeanne Moldenhauer, Excellent Pharma Consulting

  • New physics-based technologies provide advantageous methods of contamination control without the disadvantages of many current systems
  • Identification of a new phenomenon that occurred in nature, that can now be used on demand and in a controlled fashion to inactivate microorganisms, viruses, and pollen
  • Presentation of real data from international laboratories and sites showing the effectiveness of this technology
  • Discussion of other potential applications

Contamination Control Strategies for Pharmaceutical Grade Water systems: Keeping it Clean and Preventing Biofilms
Dr Michael Miller, Microbiology Consultants

  • Review most common water systems, designs and microbial specifications
  • Identify design flaws and maintenance issues that lead to contamination and biofilm
  • Provide recommendations for gaps with a focus on contamination case studies

A Disinfectant Field Trial that Meets Annex I Guidance
Jim Polarine, Steris Corporation

  • A field trial of biopharmaceutical disinfectants - a component for a CCS
  • Ready-to-use quaternary ammonium disinfectant and a hydrogen peroxide/peracetic acid sporicide used to control bioburden in a new cleanroom after construction.
  • Impact of material flow, engineering controls, supplies and operating procedures
  • EM Data evaluation and synopsis

Taxonomy, Nomenclature, Genealogy of Type Culture Strains
Miriam Guest, Charles River Laboratories

  • Understanding the use of test strains in QC Micro
  • Variation in recommended test organisms in the Pharmacopoeia
  • Understanding the importance Taxonomy and Nomenclature

Facts or Fake? Interpretation and significance of microbiological test results
Dr Frank Mertens, Saercon

  • (In-)Accuracy of microbial count
  • Definition of specifications and limits
  • Some general challenges for identification methods

Primary Validation of Flow Cytometry as Online Bioburden Monitoring
Dr Jürgen Illerhaus, BWT

  • Presentation of the method and its applications
  • Fundamental questions for RMMs... What do we really measure and how can the data be interpreted?
  • Primary validation as the basis for further validation

EM Incubation Temperature – a View on a Dilemma for a QC Micro Lab
Dr Hans Joachim Anders, Novartis

  • Requirements - How useful are the guidelines?
  • Monitoring or release criteria?
  • Audit experiences
  • Thoughts on the choice and validation of an incubation regime
  • Results of comparative studies

Fact Checking On The Behavior Of Environmental Microbial Organisms In A Single Temperature Incubation Regime
Laurent Leblanc, bioMérieux

  • Overview of the regulatory landscape
  • Common incubation practices and microorganisms recovery challenges
  • Presentation of the “One media / One temperature” initiative
  • Result of an exploratory study of the impact of incubation temperature in the 30-35°C range

USP Updates on Bioburden, Endotoxins and Sterility Assurance/Microbial Control
Marsha Steed, JYA/Steed MicroBio

  • General principles of <1119> Bioburden Monitoring and <1119.1> Bioburden Test
  • General principles of <86> Bacterial Endotoxins Test Using Recombinant Reagents
  • Sterility Assurance and Microbial Control Subcommittee Updates

Latest Progress of Pyrogen/Endotoxin Test in Chinese Pharmacopoeia
Dr Qing He, National Institutes for Food and Drug Control

  • A brief introduction of NIFDC and CP
  • Development and requirement of pyrogen/endotoxin test in CP
  • Latest progress of pyrogen/endotoxin test based on 3Rs in CP

Effect of Container Types and Material on Endotoxin and ß-Glucan Recovery
Dr Bernhard Illes, Microcoat

  • Introduction to endotoxin masking
  • Understanding of container material (inert vs. influential) contribution to reduced endotoxin recoveries
  • Case studies with container dependent endotoxin recovery in drug formulations and of 1-3-ß-D-Glucans
  • Strategies to discover and prevent the influence of container effects

Sterilization Science; a Positive Biological Indicator (BI) Result at the End of the Proper Incubation Time: How Managing it
Luisa Bernuzzi, Mesa Labs

  • ISO and the USP expectations for a positive BI result
  • What to do if the identified orgamism is a BI organism
  • What to do if not
  • Conclusions and root cause analysis

Programme - Download



Programme of the Conference & Workshop as PDF.