Join this two-day workshop to learn about bioburden control.

Workshop Content:

General Information

• 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”?

Testing

• 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?

Limits

• 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

Deviation Management

• 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