Monday 3 August 2015

Risks of non-endotoxin pyrogens

Although bacterial endotoxin remains the most ubiquitous pyrogenic substance in pharmaceutical processing, other microorganisms or microbial toxins can potentially present a pyrogenic risk, along with some chemicals. It is incumbent upon the pharmaceutical manufacturer to assess this. In a new paper, Tim Sandle considers these various risks. The abstract reads:

“This article considers pyrogens of microbial origin and the theoretical risks they pose to pharmaceutical products. The focus of the article IS with non-endotoxin pyrogens. The reasons for this are because of the voluminous content written about endotoxins and because non-endotoxin pyrogens often receive little discussion. Despite the low risk posed by non-endotoxin pyrogens, questions of their occurrence and risks are sometimes raised by regulators through inspections and by assessors during license changes and submissions. When such questions arise the pharmaceutical manufacturer is often called upon to undertake a risk assessment. Some of the information outlined within this article could be helpful in developing such an assessment.”

The reference is:

Sandle, T. (2015): Assessing Non-endotoxin Microbial Pyrogens in Relation in Pharmaceutical Processing. Journal of GXP Compliance, 19 (1): 1-10. Online at:

If you are interested in viewing a copy, please contact Tim Sandle.

Posted by Tim Sandle

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