European Microbiology Conference 2021

European Microbiology Conference

on 5 - 6 May 2021

Highlights

Pharmacopoeial Developments and GMP Expectations
Burkolderia cepacia Complex – Regulatory Requirements and Methodology
Monitoring and New Methods – from Comparison up to Validation
Water Activity – USP and Laboratory Experiences
Endotoxin- and Pyrogen Testing
ECA - OOS/OOL Guide: New Chapter for Sterility Test Failures

Objectives

This event offers you a unique possibility to become acquainted with ongoing regulatory requirements, the development of microbiological methods for quality and process control as well as with the recent experiences in microbial contamination control.

Speakers from different scopes of pharmaceutical microbiology will give you the chance to get to know the different views on versatile microbiological topics. Also, as a participant you will have ample opportunity to ask questions in several Q & A Sessions throughout the conference.

Background

The role of pharmaceutical microbiology is getting more and more important. The microbial control concept also 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 the 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:

Pharmaceutical and biopharmaceutical companies
Academic Research Institutions
Government agencies
Contract service laboratories

who are involved in

Contamination control
Monitoring
Product Testing
Validation
Quality affairs
Regulatory affairs
Research and development

Moderators

Dr Sven M. Deutschmann,
Roche, Chairman ECA Pharmaceutical Microbiology Working Group

Axel H. Schroeder,
Administration Manager, Pharmaceutical Microbiology Working Group

Programme

	Implementation of European Pharmacopoeia methods: conventional methods versus alternative methods Emmanuelle Charton, EDQM Conventional methods, “suitable” methods, “example” methods, “substitute” methods, “alternative” methods: how to find your own method of choice and how to implement it. How much flexibility is provided by Ph. Eur.?
	Experiences with Burkolderia cepacia Complex Part 1 Laboratory Experience with existing Methods, Christian Lomb, Labor LS Part 2 Specific Growth Media, Laurent Leblanc, bioMérieux Part 3 PCR, Tony Cundell, USP
	Case Study - Comparison of Monitoring Systems Peter Huonker, Früh Packaging Technology Application area and function Comparison of two monitoring systems - Valimon from ValiSys and Labwatch Monitoring from GE (Amphenol) Pros/Cons
	Continuous microbial air monitoring for aseptic filling lines Dr Kai Nesemann, Sartorius Continuous air sampling for 8 hours non-stop using the Gelatine-Membrane-Filtration according to Annex 1 Presentation of a case study comparing the traditional impaction method with the filtration method with regard to microbial recovery
	Water Activity Part 1 – USP <992> Martin Coffey, USP Expert Volunteer
	Water Activity Part 2 - An important factor forrisk assessment Christine Weß, Labor LS Practical Experiences Application in the context of risk assessment
	Experiences and Data from OWBA – Online Water Bioburden Analyser Jesper Hjorth, Novo Nordisk Experience with different OWBA’s on PW and WFI Comparison of online data from different water types Status on OWBA implementation in Novo Nordisk
	VBmicro: a suitable lab device for bioburden determination of water and buffers in less than 1 hour Dr Ulrich Zuber & Michaela Ann Kinney, Roche Feasibility studies Steps to implementation
	Inspection of Micro Labs /Expectations of an Inspector on microbiological QC Dr Rainer Gallitzendörfer, Local Government of Upper Bavaria
	Performance Testing of Membrane Filters Barbara Gerten, Merck The revised ISO 7704 – background and changes Batch testing by demonstrating the suitability in the whole system in combination with the specific culture medium Additional testing for new types of membrane filters or in case of problems
	Microbial control in Downstream of biopharmaceutical manufacturing Dr Jan Feuser, Boehringer Ingelheim General aspects of microbial control strategy Microbial weak spots in Downstream manufacturing Approaching a bioburden investigation Attributes of microbial assessments
	Endotoxins versus pyrogen testing: how the European Pharmacopoeia texts can help Ioana Venet, EDQM An overview of the sources of information on these aspects in the Ph. Eur. A presentation of the current requirements in the Ph. Eur. texts An update on the Ph. Eur. methods that can be used for the testing of pyrogens and/or endotoxins
	Determination of Pyrogens: optimization of the MAT for Medical Device testing Wolfgang Rudy & Larissa Nkenmei-Pietsch, TentaMedix GmbH Endotoxin vs. Non Endotoxin Pyrogen detection in vitro Monocyte Activation Test as in vitro replacement of the Rabbit Pyrogen Test Pyrogens and Medical Devices Cytokine multiplexing
	New Chapter of ECAs OOS/OOL Guide: Guidance for sterility test failures Dr David Roesti, Novartis General Procedure Timelines Obvious laboratory failure prior to completion of the test 5 Laboratory invstigation – fro, ID up Conclusion Level II Full scale investigation Batch disposition and health authority notification