Case Study | Resolving a Leachable Substance From a Laminated Pouch During Stability Monitoring
Extractables and Leachables For Container Closure Systems
Multilayer laminated pouches are common secondary packaging components for pharmaceutical products. Where there is potential for migration of a of a substance from the pouch to the drug product, the risk must be evaluated through robust extractables and leachables studies.
In this case study, our expert, Tino Otte, Head of Sales and Consulting at Intertek in Switzerland, describes the steps taken during an extractables and leachables study of a laminated pouch during stability monitoring where an unknown leachable substance was observed and then identified.
Please complete the form to download our case study:
Multilayer laminated pouches are common secondary packaging components for pharmaceutical products. Where there is potential for migration of a of a substance from the pouch to the drug product, the risk must be evaluated through robust extractables and leachables studies.
In this case study, our expert, Tino Otte, Head of Sales and Consulting at Intertek in Switzerland, describes the steps taken during an extractables and leachables study of a laminated pouch during stability monitoring where an unknown leachable substance was observed and then identified.
Please complete the form to download our case study: