可推断出的 & Leachables 测试 Reports

As a world-leading healthcare provider, im体育APP 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 可推断出的 and Leachables (E&L) testing it is important that reports are clear, concise and accurate.

im体育APP’s 从事专家 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, im体育APP provides two types of reports for E&L testing programs; 可推断出的 and Leachables Materials Assessment and 可推断出的 and Leachables 测试 Report. 

可推断出的 and Leachables Materials Assessment describes the justification for study protocol while 可推断出的 and Leachables 测试 Report outlines the goals of the testing and the methods applied. 

可推断出的 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 包装
• Review of regulatory compliance for each material
• Overall leachables risk
• 推荐E&学习计划

可推断出的 and Leachables 测试 Report

• 明确的目标
• 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 im体育APP advantage 

Our reports define the leachable risk of each material used in the test system, justify the E/学习计划 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.