Live Online Training: Bioburden - Regulatory Expectations and Practical Experiences

Live Online Training: Bioburden - Regulatory Expectations and Practical Experiences

Course No 18658

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Dr Marja Claassen-Willemse, MSD, The Netherlands
Dr Jörg Degen,ITM Isotopen Technologien München AG, Head of Microbiology
Dr Sven M. Deutschmann,Roche Diagnostics GmbH, Germany
Nicole Klüh, Labor LS
Dr Sebastian Thölken, Novartis Pharma Stein AG, Switzerland
Radhakrishna Tirumalai, Ph.D., USP


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


In their Pharmacopeial Forum 39(4) in 2014, the USP published the draft of chapter <1115> “Bioburden Control of Nonsterile 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 Live Online Training 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

Technical Requirements

For our Live Online Training Courses and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.

At you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in.  Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.


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
  •  Refresher on biofilms including case studies
    •  Biofilm biology
    •  How to recognize biofilms in bioburden trends
    •  Lessons learned from a company
  • 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 ?
  • 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
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
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:
  • USP<1115> Bioburden Control of Non-Sterile Drug Substances and Products
  • Refresher on biofilms including case studies
  • 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
    • Various types of bioburden testing 
    • Technical challenges: Non-Steriles up to ATMP
    • Practical Examples - from classic Pharmaceutical Products to HCT/Ps
  • Assessment of Bioburden Excursions in Non-Sterile Biologics Manufacturing Processes

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