Workshop Bioindicators

07 May 2019

Barcelona, Spain

Course No 17236

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Speakers

Peter Annel, Novo Nordisk
Walid El Azab, Steris
Christian Doriath, Skan
Berthold Düthorn, Robert Bosch Packaging Technology
Verena Ehrlicher, Microcoat Biotechnologie
Barbara Gerten, Merck
Nadja Gilles, Miltenyi Biotec
Phillip Godden, Protak Scientific
Marcel Goverde, MGP Consulting
Peter Huonker, Früh Verpackungstechnik
Annett Kilic, Greiner Bio-One
Patrick Koch , CSL Behring
Erika Pfeiler, US Food and Drug Administration
Frank Pavan, Eurocom S.A.R.L.
Radhakrishna Tirumalai, United States Pharmacopeia Convention
Blandine de Saint-Vis, Boehringer Animal Health
Matthias Schaar, Novartis Pharma Stein AG
Robert Schwarz, FH Campus Vienna
Alexandra Stärk, Novartis Pharma Stein AG
Ulrich Zuber, F. Hoffmann-La Roche

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.

Background

Manufacturers of sterile medicinal products as well as producers of medical devices should provide safe and microbiological unobjectionable products. Therefore, they have to validate their processes for sterilisation, for autoclaving and for room gassing and fogging. In addition to multidisciplinary teamwork, this also requires suitable and high-quality bioindicators. USP <1035> defines BI as a characterized preparation of a specific microorganism that provides a defined and stable resistance to a specific sterilisation process which will be used in the performance qualification of the sterilisation equipment as well as in the development and establishment of a stable , validated sterilisation processes.

Target Group

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

Programme

USP Thinking on Bioindicators
Radhakrishna Tirumalai, USP
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

Biological Indicators for H2O2 Biodecontamination - Requirements, BI Production, Quality Control
Verena Ehrlicher, Microcoat Biotechnologie GmbH
Dr. Berthold Düthorn, Robert Bosch Packaging Technology
User requirements for H2O2 process validation
Challenges of BI development and results
Case study: Application of new BIs

Bioindicators – Expectations and Reality from
Manufacturers’ and Users’ Point of View
Christian Doriath, Skan
Expectations from regulatory requirements, customers and manufacturers
H2O2 Biological Indicators (BI): Model behavior of BI and design of BI components

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
Routine control of bioindicators for steam
sterilization
Matthias Schaar, Novartis
Requirements
Spore count determination
D-value determination

Industrial Experiences
Peter Annel, NovoNordisc

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

Enzyme BioIndicators
Phillip Godden, Protak
Frank Pavan, Eurocom
What is an Enzyme Indicator
Key improvements compare to Biological Indicators
Case studies

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