Chemical Analysis - Stevanato Group
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Chemical Analysis

The SG Lab and Nelson Labs Europe (Formerly Toxikon Europe) are able to supply the most advanced and complete systems for the chemical characterisation of primary packaging, in order to detect and mitigate the risk of chemical interaction with pharmaceuticals.

Chemical feedback from the container closure system improves the possibility of performing a risk mitigation process (preliminary assessment) for the container closure’s potential interaction with a pharmaceutical, consisting in:

  • Delamination
  • Protein aggregation
  • Loss of potency
  • Toxicity
  • Surface absorption
  • Forensic analysis (contamination)
  • Material identification
  • Etc…
  • Studies on full delamination propensity (according to the USP <1660> Guideline)
  • Extractable studies on polymer/rubber container/closure components
  • Pre-screening leachable studies
  • “Formal” leachable studies in support of regulatory submissions
  • Identification of “unknown extractables”
  • Structural elucidation of “unknown” organic impurities in pharmaceutical products 
  • Pharmacopoeia (USP, EP, JP) testing
  • Tungsten analysis
  • Contamination identification     
  • Material characterisation
  • TOX-RAY™: screener database to assist in unique identification of over 5,000 extractables
  • Headspace GC/MS: volatile organic compounds
  • GC/MS or GC/QQQ: semi-volatile organic compounds
  • GC-Q-Tof: semi-volatile organic compounds
  • LC/QQQ: non-volatile organic  compounds
  • LC/high-resolution MS: non-volatile organic compounds
  • UPLC-Q-Exactive Orbitrap: non-volatile organic compounds
  • ICP/OES or ICP/MS: metals & elements
  • Ion chromatography: anions  
  • FT-IR spectrometer: organic  compounds/materials 
  • FT-IR microscope: organic  compounds/materials at trace level


Partnership with Nelson Lab

In January 2017, SG Lab signed an agreement with Nelson Labs (formerly Toxikon Europe) based on the mutual exchange of state of the art knowledge, expertise and capabilities.

Nelson Labs is an independent, privately owned Contract Research Organisation, specialized in providing premium Extractable & Leachable Services to the Pharmaceutical Industry. 

This strategic partnership enables SG Lab and Nelson Labs to leverage their collective expertise in premium container/closure development for small volume parenterals, the in-depth scientific knowledge and supporting cutting-edge analytical technologies.

Creating and offering a suite of world-class supporting services which would allow Pharmaceutical and Biopharmaceutical companies to move much faster in the qualification and acceptance process of Ompi’s container/closure systems, is the main object of this collaboration.

 

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