Comprehensive extractables and leachables test reporting to demonstrate regulatory compliance.
When performing extractables and leachables (E/L) testing it is important that reports are clear, concise, accurate and fully interpretative to demonstrate to the regulatory agencies that a proper risk-based approach was applied.
At Exova we provide two types of reports for extractables and leachables testing programs to offer a complete solution to your testing requirements.
Extractables and Leachables Materials Assessment
Describing the justification for study protocol
- 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
Outlining the goals of the testing and the methods applied
- 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
Exova’s 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.
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1300 First State Blvd, Suite C,
Wilmington, DE 19804
Contact: Waheed Sheikh - President
Tel: +1 302-636-0202
Fax: +1 302-636-0204