Speakers
Dr. Erika Pfeiler, FDA
Robert Schwarz, Baxalta
Heike Esch, Skan
Jörg Degen, Eurofins
Donald C. Singer, Vice Chair of USP Microbiology Expert Committee
Matthias Schaar, Novartis
Objectives
This workshop will show you 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. This needs a multidisciplinary team work but additionally suitable biological indicators 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
Pre-Conference Workshop on Bioindicators:
The Various Roles of Biological Indicators in Pharmaceutical Manufacturing –
an FDA Perspective
BIs as load monitors – FDA’s parametric release policy
BIs in validation and qualification – are reduced incubation times and/or reduced spore counts appropriate?
Evolution of the FDA’s Centers perspectives on BI use for drugs and devices
Case studies of BIs in sterility assurance
BI in sterilisation validation – old hat or state of the art with pitfalls?
Comparative D-value study
Time is money – Potential for optimizing analytics
F-value concept vs biological system
Bioindicators – expectations and reality
Expectations from regulatory requirements, customers and manufacturers
H2O2 Biological Indicators (BI): Model behaviour of BI and design of BI components
Biological indicators – helpful tools for process validation
Product types
Test strains
Characteristics
Manufacturer’s and user’s responsibilities
Application
Methods
Pharmacopoeial Requirements in USA
Relevant chapters
Last developments and revisions
Incoming control of bioindicators for steam sterilization – practical example
Requirements
Spore count determination
D-value determination
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