Mérieux NutriSciences | Pharma & Healthcare performs Extractables & Leachables (E&L) studies, providing a fully integrated testing strategy, together with toxicological assessment and risk analysis, drawing on more than 20 years of experience in food contact materials and applying this knowledge to medical devices and pharmaceutical product containers as well.

Extractables & Leachables Studies: Our Lab

Structure & Capabilities of our Laboratory

The Team

• 3 dedicated Project Managers for the coordination of E&L studies
• Dedicated analysts and laboratory for conducting E&L testing with state-of-the-art instrumentation
• Expertise in the evaluation of:
  – Different polymers and contaminants
  – Migration processes

Capabilities

Our know-how on the evaluation of different polymers and contaminants, and our knowledge on migration processes give us an edge in conducting extraction studies (with multiple technologies and equipment available on-site.).

Database

• In order to create new dynamic databases, the information obtained during the investigations has been complemented by evaluations of specific standards already available to the laboratory for VOC, SVOC and NVOC analyses on other matrices. In addition, public database cross-references enabled further enrichment of the compound database.
• Proprietary libraries for target analyses to be performed at each study have been developed thanks to the investigations and evaluations performed by our researchers: over 1,000 molecules were selected based on frequency of detection in previous analyses, presence in more than one public database, and availability of reference materials. However, the database is continually evolving thanks to ongoing expert input. The selected molecules are in fact our starting point, and as the studies and evaluations progress, the libraries will gradually be implemented with new compounds, improving their accuracy, reliability, and ability to provide precise identifications.

Accreditations

• Our experience on validation studies for drug products, and our high laboratory standards, allow us to perform leachables studies that have recognized value by international regulatory authorities such as the FDA.
• All Mérieux NutriSciences laboratories comply with the ISO 17025:2005 standard, certified by Accredia, the Italian accreditation body. Thanks to a mutual recognition agreement with the national accreditation bodies of more than 35 countries, the accreditation granted by ACCREDIA enhances the international recognition of customer test reports.
• Accreditation and validation of migration test methods on specific FCM compounds (depending on the compound).

Our Extractables & Leachables Experts

Extractables & Leachables Services

Extractables and Leachables studies provide a fully integrated testing strategy together with toxicological assessment and risk analysis, in six main steps:

1. Profiling of extractables: generation of the extract
2. Characterization of extractables
3. Primary and secondary leachables profile
4. Unknown extractables/leachables tentative identification by HRMS techniques (if needed)
5. Toxicological evaluation and risk assessment
6. Development and validation of targeted methods suitable for the quantification of critical leachables

Case Studies

Regulatory References

Pharmaceutical packaging can release chemicals into the drug product that cannot only impair its effectiveness, but also be harmful to the patient. This is why international authorities such as WHO, FDA, and EMA all agree upon chemical characterization being a critical step in ensuring patient safety.

Chemical characterization is the process of “obtaining chemical information about pharmaceutical packaging, relevant to its 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 (extractables testing) or the drug product itself (leachables testing).

Get our White Paper on Extractables & Leachables!