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Video: Extractables and Leachables

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.

Topics: Company News Extractables & Leachables Analytical Development Drug Product Extractables Studies Videos

White Paper: A Practical Approach to Extractables and Leachables on Manufacturing Surfaces

The study of extractables and leachables is among the fastest-evolving disciplines in the pharmaceutical industry. Until recently, the primary focus of these studies has been components in direct contact with the drug product for extended periods, such as the primary packaging, or those that contact the formulation during administration, known as in-use componentry. However, the components used in manufacturing are of increasing interest as sources of potential leachables. Many components are single-use systems (SUS), polymeric in construction, and pre-treated prior to use. Each of these factors increase the potential for leachable compounds. In order to evaluate materials for potential leachable compounds, one must leverage a scientifically rigorous study design against the specific potential for drug product and packaging/surface interaction. 

Topics: Thought Leadership Resource Center Extractables & Leachables Drug Product Extractables Studies Analytical Evaluation Threshold