Element have one of the world's most extensive and experienced extractables and leachables (E&L) practices. Together, we'll ensure regulatory compliance with a risk-based approach to E&L studies.

 

Evaluate Risk with Robust E&L Studies

Element's extensive expertise across regulatory guidance, materials science, and cutting-edge equipment ensures efficient and successful completion of E&L testing studies for a diverse range of pharmaceutical and medical device products.

Our team develop efficient, risk-based E&L testing protocols to provide detailed, accurate results alongside scientific justification for study protocols and test methods. You'll receive fully interpretive reports and expert insights by our highly trained scientists.

Get the risk-based supporting data needed for your regulatory submission and evaluate potential risk when suppliers change materials. You'll stay up to date with changes in guidelines and industry requirements when you work with Element. 

 

Key Benefits of E&L Testing

  • Safeguarding Patient Safety: Using accurate E&L test data to determine potential risk to patients and ensure end-user safety.
  • High Quality Results: Choose one of the world's most experienced E&L providers delivering industry-leading solutions.
  • Meeting Regulatory Requirements: Navigate the most efficient path to compliance with regulatory agencies requiring E&L data including the FDA, EMA, MHRA.
  • Expediting Time to Market: Facilitating the swift and efficient completion of E&L testing programs to ensure timely regulatory approval and market entry.
  • Complex Study Protocol Understanding: Providing in-depth understanding of acceptable protocols and reports, crucial to avoiding costly delays in regulatory submissions.

 

Meeting Regulatory Expectations for E&L Analysis

Regulatory agency expectations evolve continually, demanding increasingly strict criteria for assessing the materials of new drug products or medical devices. Our scientists perform E&L studies following both regional guidance and international standards. We leverage regulatory expertise, decades of experience, and a strong E&L program, to provide a swift and efficient pathway to regulatory approval.

  • ISO 10993: Biological evaluation of medical devices (parts 18, 12, 17)
  • ISO 18562: Biocompatibility evaluation of breathing gas pathways in healthcare applications
  • USP <661>: Containers – ophthalmics – plastics
  • USP <661.1>: Plastic materials of construction
  • USP <661.2>: Plastic final packaging systems
  • USP <665>, USP <1665>, (BPOG): Characterization and Qualification of Plastic Components and Systems.
  • USP <1660>: Glass qualification
  • USP <1663>: Extractables (pharmaceutical packaging/delivery systems)
  • USP <1664>: Drug product leachables (pharmaceutical packaging/delivery systems)

The Extractables and Leachables Study Process

Assess Risk

Review all materials involved in the study in order to define the scope.

Ascertain Extractables

Use appropriate solvents to extract compounds that could potentially be leachables.

Toxicology Risk

Determine the toxicology risk to the patient through extractable and leachable studies.

Target Leachables

Quantitate harmful leachables in the final product to determine the actual risk that they pose.

Reporting

Provide detailed feedback to help clients comply with standards and reduce the likelihood of delays to market.

Industry Leading Life Science Laboratory Analysis

Our Manchester facility is home to over 50 life science experts dedicated to helping our clients ensure patient safety.

We bring cutting-edge extractable & leachable techniques, state-of-the-art equipment, and knowledge of regulatory standards to provide high quality analytical data to help you make key decisions on your product.

Contact our laboratory directly.

Analytical Evaluation Threshold

Life Sciences Content

Check out our Life Sciences thought leadership content including webinars, white papers, case studies blogs and more.

Written by our industry experts, we tackle a range of subjects across Antimicrobial, Biotechnology Food, Medical Device, Pharmaceutical, and Personal Care industries.

With a commitment to absolute certainty, we utilize our extensive expertise and experience to provide insights that ensure the safety of materials used in the life science sector.

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