Nelson Laboratories, Inc.

Nelson Laboratories, Inc.
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Nelson Laboratories, Inc.

 •  February 7

Using chemical characterization to support biocompatibility assessments and cleaning validations for medical devices is now widely accepted, but it remains a moving target as the approaches develop. A variety of chemical characterization strategies are now available with differing degrees of scientific rigor and diverse regulatory body acceptance....

Nelson Laboratories, Inc.

 •  February 1

The Packaging Department at Nelson Laboratories is often asked by manufacturers “What do I need to do to validate my packaging?” or “What package testing do I need to have performed in order to comply with regulations?” There is not a one-size-fits-all answer to these questions as unique product, packaging, and sterilization combinations require...

Nelson Laboratories, Inc.

 •  December 18, 2017

By: Gregory Grams, Michael Padilla, Peter Strain, Thor Rollins The Current Regulatory Landscape for EO Residue Levels in Medical Devices: What Manufacturers Need To Know Now, and What May Be on the Horizon Ethylene oxide gas sterilization, in particular, is one of the most efficient and effective ways of deactivating bacteria and other potentially...

Nelson Laboratories, Inc.

 •  November 14, 2017

Sterile barrier systems are key components in medical device sterilization, so selecting the right barrier is essential. Reusable medical devices,prior to use in healthcare facilities, must undergo validation testing to demonstrate the effectiveness of the cleaning instructions and the microbiocidal instructions that will be provided to the...

Nelson Laboratories, Inc.

 •  November 8, 2017

In March of 2017, the new ISO 18562 standard series was released. This standard covers the general principles regarding biocompatibility assessment of medical device materials which comprise the gas pathway. This standard greatly increases the scrutiny for gas path devices and their required tests. This presentation will cover the required...

Nelson Laboratories, Inc.

 •  October 31, 2017

Acquisition creates the leading global extractables and leachables lab testing platform to serve the pharmaceutical and medical device industries CLEVELAND, OH. – Oct. 31, 2017—Sterigenics International LLC announced today that it has acquired Toxikon Europe N.V., the European division of Toxikon Corporation, a Bedford, Mass.-based preclinical...

Nelson Laboratories, Inc.

 •  October 25, 2017

The AAMI Sterilization Standards Meetings were held on 16-18 October 2017. There were almost 300 medical device manufacturers, FDA personnel, heath care facility personnel, testing laboratory personnel, consultants, and others in attendance. One item of interest from USFDA/CDRH is that the Office of Device Evaluation (ODE), Office of Compliance...

Nelson Laboratories, Inc.

 •  October 3, 2017

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...

Nelson Laboratories, Inc.

 •  August 9, 2017

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...

Nelson Laboratories, Inc.

 •  August 4, 2017

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...