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Bacterial Endotoxin Testing

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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March 23, 2016

Updated Pyrogenicity Considerations for New Medical Devices

Effective March 21, 2016, FDA released updates to the guidance Submission and Review of Sterility Information in Premarket Notification (501(k)) Submissions for Devices Labeled as Sterile: Guidance for Industry and Food and Drug Administration Staff. Specifically, the document addresses an...

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February 24, 2016

3-D Medical Device Validation

Three-dimensional (3-D) printed medical devices are becoming more common in the industry. Subtractive manufacturing, the more traditional method for a milled device, consists of starting with a block of material and removing different parts of the material in order to...

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October 4, 2013

Nelson Labs Automates Bacterial Endotoxin Test

Nelson Labs’ bacterial endotoxin (BET) test is now fully automated! As of August 2013, the new paperless system generates final reports directly from raw data entered into the endotoxin testing software. As soon as the raw data and final report...

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