Bioburden Workshop
Regulatory Expectations and Practical Experiences
Im Auftrag der ECA Academy

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.