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Controlling Endotoxin Contamination During Pharmaceutical Production

Published Date: May 31, 2023

Join this webinar to learn how to prevent endotoxin contamination during pharmaceutical production, as well as to gain insights into sampling plans, test methods, and method optimization.

Key Takeaways

  • Learn about the possible contamination sources and how to limit and control introduction of endotoxins.
  • Understand how to set up a formal endotoxin sampling plan.
  • Find out how to identify critical control points.

More Information

Endotoxins are substances that cause a fever when in contact with blood or cerebrospinal fluid. Endotoxins are a part of the cell wall of gram-negative bacteria, so endotoxin contamination is always linked to bacterial contamination.

Endotoxins are very resistant to most sterilization processes like steam, ethylene oxide (EtO/EO) sterilization, radiation sterilization, and disinfection methods. Obtaining endotoxin-free end products should thus mainly be based on preventing introduction of contamination rather than removal or destruction. Therefore, it essential to understand the effect the manufacturing process has on endotoxin contamination.

Endotoxin-free pharmaceuticals, like sterile pharmaceuticals, cannot be assured simply by end product testing. It is important to be aware of the possible contamination sources in order to limit and control the introduction of endotoxins. The identification, sampling and testing of endotoxin contamination sources should be part of a formal endotoxin sampling plan.

When considering a sampling plan for the control of endotoxins, one must consider all possible sources of contamination. From this knowledge critical control points (CCP) should be identified. CCPs can be defined as places in the process where endotoxin can either be added to or eliminated from the system. Testing and setting limits of identified intermediate CCPs will provide the drug or device manufacturer with a significant measure of risk control.

In conclusion, endotoxin sampling plans and testing schemes are vital for manufacturing endotoxin-free end products. Sampling plans should be based on knowledge of the production process and the origin and characteristics of endotoxins.

Learn more about the presenter below.


Peter Cornelis

Senior Microbiology Expert

Peter Cornelis graduated from the Catholic University of Leuven, Belgium, in 2000 with a master's degree in Applied Biological Sciences. In 2003 he started working for Toxikon Europe (acquired by Nelson Labs) as a study director in microbiology and in-vitro toxicology. From 2007 to 2016 he was department supervisor for microbiology and in-vitro toxicology. Since 2016 he has been responsible for research, validation, and development of new microbiological and in-vitro toxicological methods. Peter is a member of the ISO committee TC 194 WG5, Cytotoxicity and WG 8, Irritation and Sensitization.

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