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medical device sterilization

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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December 7, 2021

Which parameters must be validated during a steam sterilization validation?

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...

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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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April 7, 2015

MD&M Texas

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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