The new cleanroom at our global headquarters in Salt Lake City, Utah, was designed for today's rigorous contamination control expectations, driven by EU GMP Annex 1. Learn More
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...
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...
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...
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...
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...
