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.
- Expertise and Experience: Extensively experienced team of experts supported by a global network of extractables and leachables testing sites.
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)
'An Introduction to Extractables & Leachables Testing'
Discover Extractables & Leachables Testing in our on-demand webinar featuring Mike Ludlow, Element's Market Development Manager for E&L. Gain essential insights into study design, regulatory compliance, and risk-based approaches. Ideal for pharmaceutical and medical device professionals seeking effective E&L testing implementation.
The Extractables and Leachables Study Process
Review all materials involved in the study in order to define the scope.
Use appropriate solvents to extract compounds that could potentially be leachables.
Determine the toxicology risk to the patient through extractable and leachable studies.
Quantitate harmful leachables in the final product to determine the actual risk that they pose.
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.
Get to know Element
Here are a handful of our services to help you achieve regulatory approval quickly and efficiently.
ISO 18562 Testing: Biocompatibility Analysis
Element provides ISO 18562 biocompatibility analysis for respiratory and ventilation devices to support global device approval.
USP 665, 1665 and BPOG Services
Ensure compliance for single-use systems (SUS). Our testing services provide high-quality results, safeguarding patient safety, fulfilling your regulatory requirements, and expediting time to market.
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.
Extractables and Leachables Studies
Our extractables and leachables studies offer tailored solutions that ensure patient safety and compliance with industry standards.
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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