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Author: Piet Christiaens





December 11, 2019

The Case against “Lazy” E&L-Identifications in GC/MS

In Chemical Characterization studies for Medical devices, as well as in Extractables & Leachable Studies for Pharmaceutical Packaging Systems, it is of the utmost importance that one can correctly identify the compounds encountered by your screening methods. The reason for...

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November 5, 2019

OFFICIAL AMES REPORT ON HALO-RUBBER OLIGOMERS (C13) NOW AVAILABLE AT NELSON LABS EUROPE

  During their Extractable & Leachable Qualification work, many Pharma and Biopharma companies qualifying their Small Volume Parenteral Container Closure systems (vial, syringe, or cartridge) may have come across certain compounds that they now recognize as rubber oligomers. While the...

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August 19, 2019

Chemical Characterization Has Come a Long Way

Prior to this past spring the latest version of the ISO 10993 Part 18 was more than 13 years old and was more of a descriptive standard highlighting what kind of techniques and approaches one could possibly take.  There was...

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June 26, 2019

Rocking the Cradle or Rattling the Cage?

As I mentioned in my previous blog, Extractables and Leachables (E&L) for pharmaceutical packaging systems is a relatively new science, and what is true for pharma systems is just as true for Chemical Characterization of Medical Devices. While E&L was...

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May 3, 2019

Thought Leadership in Extractables & Leachables Testing

Introduction By Jeffery R. Nelson, President, Nelson Labs In October 2017, Nelson Labs acquired Toxikon Europe N.V., the European division of Toxikon Corporation. Shortly after the acquisition, we renamed the organization Nelson Labs Europe.  Based in Leuven, Belgium, Nelson Labs...

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