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About

Join SGS at the Extractables & Leachables Virtual Summit 2020. Don't miss Dr. Andreas Nixdorf's presentation on Leachable Study Design.

Starts

October 22, 2020, 12:00

Ends

October 23, 2020, 18:30

Location

Online

The 2nd annual Extractables & Leachables Virtual Summit 2020 will provide industry experts with the latest updates on regulations, analytical testing, risk & safety assessment, and biocompatibility.

Presenting @1:10pm

Our expert Dr. Andreas Nixdorf, Business Development Manager for E&L Testing, will be presenting on Friday, October 23 @1:10pm "Leachable Study Design Space in Complex Formulated Drug Products Such as Biopharmaceuticals."

Our Services

Extractables and leachables (E&L) studies enable the quantification and identification of the risks of potentially toxic leachable impurities migrating into a medicine, or medical device, from container closure systems, processing equipment or packaging.

Our services include:

Pharmaceuticals:

  • Extractables on final packaging
  • Extractables on process materials (SUS)
  • Leachables screening
  • Method development and validation
  • Leachable stability studies
  • Toxicological assessments

Medical devices (MD):

  • Chemical characterization of MD
  • Leachables/simulation study
  • Topographical methods
  • Particle identification and determination
  • Failure mode analysis
  • Toxicological assessments