As a world-leading healthcare provider, Element supports clients with the preparation of extractables and leachables test reports to prove regulatory compliance and provide a solid risk-based set of supportive data.
When performing Extractables and Leachables (E&L) testing it is important that reports are clear, concise and accurate.
Element’s Engaged Experts combine our advanced equipment with in-depth knowledge of materials and regulations to ensure our testing reports are fully interpretative to demonstrate to the regulatory agencies that a proper risk-based approach was applied.
Types of extractables and leachables testing reports
As a complete solution to your testing requirements, Element provides two types of reports for E&L testing programs; Extractables and Leachables Materials Assessment and Extractables and Leachables Testing Report.
Extractables and Leachables Materials Assessment describes the justification for study protocol while Extractables and Leachables Testing Report outlines the goals of the testing and the methods applied.
Extractables and Leachables Materials Assessment Report
- Properties of the material of construction
- Forecast of typical extractables
- Utilization of vendor extractables data to mitigate risk
- Leachables risk of secondary packaging
- Review of regulatory compliance for each material
- Overall leachables risk
- Recommended E&L study plan
Extractables and Leachables Testing Report
- Clear objectives
- References to the appropriate testing “best practices”
- Calculation of Analytical Evaluation Threshold (AET)
- Justification for standards and method verification/validation
- Quantitative analysis and identification of E&L
- Limit the number of unknown extractables
- Determination of the source of E&L
- Toxicological Safety Assessment of E&L
The Element advantage
Our reports define the leachable risk of each material used in the test system, justify the E/L study plan to mitigate this risk, and clearly detail the analytical methodologies used in the testing along with an interpretation of the data.
Our analytical laboratory features the latest state-of-the-art equipment that we operate in compliance with Good Manufacturing Practice (cGMP) and Good Laboratory Practice (GLP) quality systems. Our extensive libraries also facilitate the identification of extractables and leachables.
For more information about our extractables and leachables testing reports services or to request a quote, contact us today.
Excipient Raw Materials and Container Testing
Element has comprehensive capabilities that can be applied to the testing of excipient, raw materials, and pharmaceutical containers, enabling you to ensure the quality and safety of your product.
Trace Metal Services
Element is a recognized world-leader in trace metal analysis, providing testing for elemental impurities by ICPOES and ICPMS in compliance with USP , EP (2.4.20), and ICH Q3D guidelines.
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