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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Pharmaceutical testing facilities

2395 Speakman Dr.,
Mississauga, ON L5K 1B3

Contact: Larissa Hillar - Operations Manager
Tel: +1 905 822 4111

Fax: +1 905 823 1446

Email: americas@exova.com

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9240 Santa Fe Springs Road,
Santa Fe Springs, CA 90670

Contact: Eric Lindsay - General Manager
Tel: +1 562 948 2225

Fax: +1 562 948 5850

Email: americas@exova.com

Capabilities
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Plot 598-221, Dubai Investments Park 1, The Green Community, P.O. Box: 34924,
Dubai

Contact: Jason Dodds - Managing Director
Tel: +971 4 885 1001

Fax: +971 4 885 4004

Email: middle.east@exova.com

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