Nelson Laboratories, Inc.

Nelson Laboratories, Inc.
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Nelson Laboratories, Inc.

 •  October 3

Sterigenics International and Noxilizer announce partnership to provide NO2 sterilization for pharmaceutical, biotech and medical device products Agreement supports customers with global manufacturing networks October 3, 2017 (Baltimore, MD and Broadview Heights, OH) Noxilizer, Inc. and Sterigenics International LLC announce the signing of a global...

Ensuring pharmaceutical products and medical devices are sterile and free of contamination is a dividing line between meaningful treatment and harmful disservice. This concept applies to nearly every section of the medical device and pharmaceutical realm. In this battle for sterility, packaging integrity should be a chief focus. A package with a...

Fourier transform infrared (FTIR) analysis is a popular analytical tool for material screening. The technique works because each different type of molecular bond in a molecule vibrates differently, and there is often a set of molecular vibrations that involve the entire molecule that form a characteristic “fingerprint.” When measuring a molecular...

There are many considerations that need to be taken into account by medical device manufacturers when designing reprocessing validations, and it only takes one oversight to cause a failure mode. Alpa Patel, Senior Scientist at Nelson Laboratories and member of AAMI, ASTM, and AATB, will share her expertise in this presentation and discuss the key...

It has become more prevalent and acceptable to use the results of chemistry testing to assess the overall biocompatibility of medical devices. For many devices with prolonged or permanent patient contact, chemistry followed by toxicological assessment can provide a cost and time saving alternative to in vivo tests such as chronic, sub-chronic,...

Nelson Laboratories, Inc.

 •  December 7, 2016

In April of 2016, the FDA released their long-awaited guidance document on ISO 10993. This 65 page document provides insights and changes to how the FDA views biocompatibility. We will discuss the top 10 items in the document that will make the greatest impact; we will also discuss how this update impacts the newest draft of ISO 10993-1. Attendees...

Nelson Laboratories, Inc.

 •  August 15, 2016

An analyst performs the Bacterial Endotoxin Test (BET). The U.S. Food and Drug Administration (FDA) released a new guidance document titled “Submission and Review of Sterility Information in Premarket Notification [510(k)] Submissions for Devices Labeled as Sterile” on Jan. 21, 2016, which underwent some small editorial changes and was updated in...