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