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Bioburden Workshop - Regulatory Expectations and Practical Experiences

: 30 Jun 2020 - 1 Jul 2020

: Berlin, Germany

Sector: Pharmaceutical

Type: Workshop

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”?


  • 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

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



ECA Academy
Phone: +49 (0)6221 84 44 0
Email: info@gmp-compliance.org
Visit: https://www.gmp-compliance.org/training

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