Bioburden Workshop - Regulatory Expectations and Practical Experiences

Bioburden Workshop  -  Regulatory Expectations and Practical Experiences

Berlin, Germany

Course No 17556




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Simon Guerrero Cruz, MSD, The Netherlands
Jörg Degen, Eurofins BioPharma Product Testing Munich GmbH, Germany
Sven M. Deutschmann,  Roche Diagnostics GmbH, Germany
Radhakrishna Tirumalai, Ph.D., USP
Nicole Klüh, Labor LS
Alexandra Stärk, Novartis Pharma Stein, Switzerland


During this workshop, the following contents and questions should be addressed by presentations and panel discussions.  Considering that, panel lists from the fields Non-Sterile Products, Sterile Products, Combination Products as well as biopharmaceutical APIs and HCT/Ps will on hand for the workshop.


In their Pharmacopeial Forum 39(4) in 2014, the USP published the draft of chapter <1115> „Bioburden Control of Non-sterile Drug Substances and Products“. The document outlines a risk-based approach to the control of potential contamination in non-sterile product manufacturing.

But “bioburden” is not only a topic of Non-Sterile Products. Annex 1 of the European GMP Guideline requires “The bioburden should be monitored before sterilisation. There should be working limits on contamination immediately before sterilisation, which are related to the efficiency of the method to be used. Bioburden assay should be performed on each batch for both aseptically filled product and terminally sterilised products.”

And last but not least, bioburden testing for medical devices made or used in the USA is governed by Title 21 of the Code of Federal Regulations and worldwide by ISO 11737.

The current developments determines us to address this topic in a special workshop session to look at this from various angles and provide you with information about the regulatory background and practical examples and strategies for bioburden control. Pharmacopoeial experts, representatives of pharmaceutical quality control and from testing laboratory will show you what are the challenges of the bioburden control strategy and how they implemented an adequate control in their companies.

Target Group

This workshop is of interest to professionals in microbiology from
  •  Pharmaceuticals and Biopharmaceutical Companies
  •  Academic Research Institutions
  •  Government Agencies
  •  Contract Service Laboratories
who are involved in
  •  Research and Development
  •  Validation
  •  Microbiological QA and QC


Topic: General Information
  • Bioburden control strategy dependent of the lifecycle phase of the product (so-called “Phase-appropriate control strategy”)
    •  Early clinical phase
    •  Late clinical phase
    •  Commercial phase
  •  Test for “specified microorganisms” and / or “objectionable microorganisms”?
    •  Raw materials
    •  In-process-control samples
    •  Drug substance
    •  Drug Product
    •  Final Product
Topic: 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 are the method in use ?
    •  TAMC
    •  TYMC
    •  MPN
    •  Any other bioburden testing method
    •  Rapid micro methods
  •  Is it necessary to  have a limited shelf life for bioburden samples?
  •  How to treat so called “missing bioburden” results ?
Topic: Limits
  • Predefined bioburden and / or endotoxins levels for your upstream / fermentation processes (if applicable) and downstream processes or for the whole process
  •  What will be 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, e.g.
    •  how many data points are required to define the limits
    •  philosophy for new processes / new manufacturing processes without having experience of process capabilities
Topic: Deviation Management
  • Do you perform ID?
    • If YES, when:
      • Each colony
      • Only in case of an excursion of limits / level
    • What’s the preferred ID technique
  • Measures in case of an excursion of a limit
Topic: 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
Presentation list:
  • European Regulations
  • USP<1115> Bioburden Control of Non-Sterile Drug Substances and Products
  • Various types of bioburden testing
  • Risk Assessment on Microbiological Control for a Low Bioburden Process
  • Microbial Control Strategy for Biopharmaceutical Manufacturing
  • Microbial Counts and Bioburden of Combination Products: Guidelines, Specifics and Case Studies
  • Bioburden for Sterile Operations
  • Bioburden Monitoring , USP<1229.3> applies to Sterile Products
  • Bioburden Testing of Modern Medicinal Products - Practical Experience of a Contract Lab
  • Technical challenges: Non-Steriles up to ATMP Assessment of Bioburden Excursions in Non-Sterile Biologics Manufacturing Processes
  • Practical Examples - from classic product to HCT/P

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