. European Microbiology Conference 2019 .

Workshop “Bioindicators”

on 07 May 2019

Objectives

This workshop will provide you with the current regulatory developments in relevant guideline documents e.g.  Ph Eur 5.1.2. USP <1229.8> or <1035> regarding Biological Indicators (BI) and practical experiences of  industrial experts and BI manufacturers on validation of processes, evaluating BI resistance and more.
Furthermore, you will get the possibility to discuss the challenges in the use of BI with speakers and colleagues during the presentation and the following panel discussion.

Target Audience

  • 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

Moderator

Dr. Sven M. Deutschmann, Roche Diagnostics GmbH
Chairman of  ECAs Pharmaceutical Microbiology Working Group

Programme

Radhakrishna Tirumalai

USP Thinking on Bioindicators

Radhakrishna Tirumalai, USP

 

Verena Ehrlicher
Dr. Berthold Düthorn

Biological Indicators for H2O2 Biodecontamination - Requirements, BI Production, Quality Control

Verena Ehrlicher, Microcoat Biotechnologie
Dr. Berthold Düthorn, Robert Bosch Packaging Technology

  • Biological Indicators ( BI) are only tools to measure efficacy of the sterilization process
  • BI is not the target of the Sterilization process. It is the bioburden in the article that is being sterilized that should be the focus for the process.
  • Complete destruction of a BI is not necessary to develop a validated sterilization process

 

Jean-Baptiste Sauvet

Bioindicators – Expectations and Reality from Manufacturers' and Users' Point of View

Jean-Baptiste Sauvet, Skan

  • Expectations from regulatory requirements, customers and manufacturers
  • H2O2 Biological Indicators (BI): Model behavior of BI and design of BI components

 

Robert Schwarz

Bioindicators in sterilization and decontamination validation - pitfalls and some maths

Robert Schwarz, FH Campus Vienna

  • Differences in bioindicators for sterilization and decontamination
  • Comparative D-Value Study
  • Time is money - considerations for optimization
  • Calculation models vs biological system

 

Matthias Schaar

Routine control of bioindicators for steam sterilization

Matthias Schaar, Novartis

  • Requirements
  • Spore count determination
  • D-value determination

 

Peter Annel

Industrial Experiences

Peter Annel, NovoNordisc

 

Walid El Azab

Biological Indicators – Common challenges observed

Walid El Azab, Steris and Customer (TBC)

  • Supplier qualification and validation (production to shipping)
  • Common challenges/failure observed at end-users’ site
  • Common challenges during QC testing
  • Failure decision tree

 

Phillip GoddenFrank Pavan

Enzyme BioIndicators

Phillip Godden, Protak
Frank Pavan,  Eurocom

  • What is an Enzyme Indicator
  • Key improvements compare to Biological Indicators
  • Case studies