Whitepaper: Use of accelerated conditions in extractables and/or leachables studies
The purpose of this Position Paper is to consider the scientific basis for accelerating extractables and/or leachables studies via the proper combination of contact temperature and duration (time). Considering this scientific basis, recommendations concerning proper acceleration strategies are provided.
Contact temperature and time are frequently chosen in extractables and/or leachables studies to accelerate the contact that occurs between a plastic material, component, or system (e.g., container closure, medical device, production suite) under typical conditions of use. A means must be established to identify and justify the proper accelerated contact conditions.
Related content from this organisation
- On-demand webinar: Testing disinfectant agents for antimicrobial action on hard surfaces
- On-demand webinar: Key elements of a sterility assurance program
- Whitepaper: Why extractables and leachables matter
- Whitepaper: The necessity of E&L qualifications for lyophilised drug products
- Application note: Why extractables and leachables matter