Bioburden Workshop - Regulatory Expectations and Practical Experiences
: 30 Jun 2020 - 1 Jul 2020
: Berlin, Germany
Join this two-day workshop to learn about bioburden control.
- Bioburden control strategy dependent of the lifecycle phase of the product (so-called “Phase-appropriate control strategy”)
- Test for “specified microorganisms” and/or “objectionable microorganisms”?
- Where is bioburden tested in processes?
- Predefinition of bioburden and/or endotoxins levels for raw materials
- Assessment of the presence/absence of “objectionable microorganisms” in your raw materials?
- What is the method in use?
- Is it necessary to have a limited shelf life for bioburden samples?
- How to treat so-called “missing bioburden” results?
- Predefined bioburden and/or endotoxins levels for your upstream / fermentation processes (if applicable) and downstream processes or for the whole process
- What is preferred? A two-tiered-control system (warning and alert level) or a three-tiered control system (warning and alert level AND rejection level)?
- Methodologies in use to define the limits
- Do you perform ID?
- Measures in case of an excursion of a limit
USP <1115> and USP<1229.3>
“Bioburden Control of Non-sterile Drug Substances and Products” - USP and Industrial View
Bioburden Monitoring, USP<1229.3> applies to Sterile Products
Who should attend?
This workshop is of interest to professionals in microbiology from:
- Pharmaceuticals and Biopharmaceutical Companies
- Academic Research Institutions
- Government Agencies
- Contract Service Laboratories