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Author: Nathan Pett





January 9, 2024

Do I need a validation prior to routine testing?

As described in a previous blog (What are the common test methods for pyrogen testing and how to choose between them?), the LAL assay is an enzymatic assay. This means that substances present in the test mixture might inhibit or...

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December 11, 2023

Extraction of Medical Devices for Bacterial Endotoxin Testing

 When performing the Bacterial Endotoxin test, we observe changes within a solution that occur as a reaction to the presence of endotoxin. As such, it is necessary that the test medium be a liquid. For pharmaceutical products, the sample is...

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November 27, 2023

What are the common test methods for pyrogen testing and how to choose between them? 

There are several methods that can be applied to detect pyrogens:  the bacterial endotoxins test (BET – including kinetic chromogenic, kinetic turbidimetric, and gel-clot techniques) historically known as the Limulus amebocyte lysate (LAL) test, the rabbit pyrogen test (RPT), the...

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June 9, 2023

Are sterile devices microbiologically safe? Unraveling the relationship between pyrogens, bioburden, and sterility

Sterility assurance is of utmost importance for medical devices that come into contact with body cavities. However, bioburden and sterility are linked to a third concern—pyrogens—which may not be adequately addressed solely by ensuring device sterility. Pyrogens and Endotoxins: Understanding...

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