December 7, 2021
Understanding the sterility assurance level To understand how steam sterilization processes are validated, it is important to understand some key concepts about sterilization. The purpose of sterilization is to inactivate microbiological contaminants, thereby rendering products sterile[1]. The kinetics of inactivation...
See BlogMarch 23, 2016
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...
See BlogFebruary 24, 2016
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...
See BlogApril 7, 2015
Nelson Laboratories will be exhibiting at the MD&M Texas show, May 7-8, 2014, at the Fort Worth Convention Center in booth #523. Presentation: Medical Device Sterilization: Selection of SAL, Evaluation of Bioburden Data, Alert and Action Levels of Bioburden Excursions...
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