Summary

Any container closure system has the potential to leach unwanted contaminants into a drug product – even something as seemingly harmless as a rubber serum stopper. Regulatory agencies require manufacturers to identify and quantify possible contaminants in all drug products at release and on stability. To meet these requirements, NSF Health Sciences developed and conducted a controlled forced extraction study on a 13 mm butyl rubber serum stopper with a laminated coating.

This white paper identifies the challenges presented to manufacturers and provides insights into the methodologies used for assessing extractables and leachables to meet the regulatory requirements.

About the Author

Suzanne Rarig is a science professional serving as a principal investigator for extractables and leachables studies. Her experience includes performing and overseeing the necessary testing to execute these studies, and evaluating the data collected to provide an extraction profile for the client’s product. She also has experience in R&D and analysis of API and drug product from Phase 1 to commercial products, as well as in-depth knowledge of GMP regulations and audit remediation tasks.