Over the years, the US Pharmacopeia (USP), International Harmonisation (ICH), Product Quality Research Institute (PQRI), and several other industry consortia have developed guidelines and best practices for these extractables & leachables studies.
Alcami has specialized knowledge of the most common materials of construction such as platinum-cured silicon, halobutyl rubber, cyclic olefins, polyethylene terephthalate (PET), polyvinyl chloride (PVC), and other elastomers. Vial and stopper configurations, spray pumps, and intravenous (IV) bags are among the most common packaging system components we evaluate. We welcome all routes of administration, including the more challenging prefilled syringes, blow-fill sealed vials, and laminated cans.
MORE CONTENT ON E&L STUDIES
- Editorial: A Practical Approach to Extractables & Leachables
- The Top Five Most Asked Extractables and Leachables Questions Answered
- ON-DEMAND WEBINAR: Extractables & Leachables 101: The Past, Present, and Future
- White Paper: A Practical Approach to Extractables and Leachables on Manufacturing Surfaces
- Extractables and Leachables – Why?