Extractables & Leachables studies in pharmaceutical packaging and medical devices.
Mérieux NutriSciences performs Extractables and Leachables studies providing a full integrated testing strategy together with toxicological assessment and risk analysis, taking advantage from more than 20 years’ experience developed in food contact materials, medical devices and containers for pharmaceutical products.
Pharmaceutical packaging can release chemicals into the drug product that can not only impair its effectiveness, but also be harmful to the patient. Similarly, medical devices can undergo leaching processes during their use that could negatively affect their clinical outcome, and compromise their biocompatibility.
This is why international authorities such as WHO, FDA, and EMA all agree upon chemical characterization being a fundamental step in ensuring patients’ safety.
Chemical characterization is the process of “obtaining chemical information about a medical device or a pharmaceutical packaging, relevant to their biological evaluation and any toxicological risk assessment”. When it comes to generating information, chemical characterization can be performed by extractables and leachables testing: guidelines change whether we are testing a pharmaceutical packaging or a medical device, but nonetheless are very similar to one another.
Extractables and Leachables studies provide a full-integrated testing strategy together with toxicological assessment and risk analysis, in six main steps:
- Profiling of extractables: generation of the extract
- Characterization of extractables
- Primary and secondary leachables profile
- Unknown extractables/leachables tentative identification by HRMS techniques (if needed)
- Toxicological evaluation and risk assessment
- Development and validation of targeted methods suitable for the quantification of critical leachables
Testing strategy according to USP <660> “Containers –Glass” and USP <1660> “Evaluation of the inner surface durability of glass containers”:
- Determination of visible and subvisible glass particles
- Determination of extracted elements
- Characterization of glass inner surface by SEM/EDS or TEM/EDS