Stevanato Group’s laboratories can supply the most advanced and comprehensive chemical characterization of the primary packaging. Chemical Analysis.
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Analyzing glass primary packaging and components to mitigate the risk of chemical interaction with drugs
Chemical Analysis
Analyzing glass primary packaging and components to mitigate the risk of chemical interaction with drugs
Partnering with Nelson Labs Europe, Stevanato Group’s laboratories can supply the most advanced and comprehensive chemical characterization of the primary packaging to detect and mitigate the risk of chemical interaction with drugs. We can assist in E&L analysis providing a multi-analytical approach for the selection of the proper container closure systems at each stage of the drug development journey.
Capabilities and testing
Full Delamination Propensity Studies (According to USP <1660> Guideline)
Extractables Studies on Polymer/ Rubber Container/Closure Components
Pre-Screening and “Formal” Leachables Studies
Identification of “Unknown Extractables” and Impurities in Drug Products
Silicone quantification
Tungsten Analysis
Contamination Identification and Material Characterization