We care about quality, patient safety and on time delivery. Partner with our experienced team for extractables and leachables testing to identify harmful impurities and eliminate potential risk to end-users. Together, we'll ensure regulatory compliance through a risk-based approach to extractables and leachables studies.
What is extractables and leachables testing?
Extractables and leachables testing is a critical need required by manufacturers of pharmaceutical, medical device, biologic, reduced-risk, and combination products, to identify and assess the risk of human exposure to potentially harmful impurities migrating from a polymeric materials.
Extractables testing involves the use of aggressive laboratory conditions to extract compounds, that allow us to assess risk and provide guidance on material suitability. Extractables studies provide a "early indication of potential risk" to support you with materials selection and product development.
Leachables testing detects chemicals that migrate into the product or to the patient under typical-use conditions. Leachables studies test the finished drug product or finished medical device.
Key benefits of partnering with us for extractables and leachables testing services
- Safeguarding Patient Safety: Using accurate extractables and leachables test data to determine potential risks to patients and ensure end-user safety.
- High Quality Results: Choose one of the world's most experienced extractables and leachables providers delivering industry-leading solutions.
- Meeting Regulatory Requirements: Navigate the most efficient path to compliance.
- Expediting Time to Market: Facilitating the swift and efficient completion of extractables and leachables testing programs to ensure timely market entry.
- Complex Study Protocol Understanding: Providing in-depth understanding of acceptable protocols and reports, crucial to avoid costly delays in regulatory submissions.
- Tailored Studies: Conducting customized studies on a variety of complex products and matrices, aligning with regulatory expectations for applicable parameters.
- Expertise and Experience: Extensively experienced team of experts supported by a global network of extractables and leachables testing sites.
Why are extractables and leachables studies important?
Extractables and leachables studies determine whether potentially harmful organic and inorganic impurities - that can alter product safety or efficacy - have migrated into a finished product from various sources such as container closure systems, manufacturing and process equipment, packaging, delivery devices or medical devices.
Testing is vital for ensuring patient safety, expediting time to market, and maintaining regulatory compliance for drug & medical product development and life-cycle management.
We excel in efficiently conducting extractables and leachables studies for pharmaceutical, medical device, biologic, reduced-risk, and combination products, to ensure patient safety and offer comprehensive solutions based on industry-leading practices. Contact our team for more information.
Regulatory compliance and risk management
Our regulatory and scientific experts support the world’s leading healthcare brands in establishing the safety of products for patients. The expectations of regulatory agencies (including FDA, EMA, MHRA, Health Canada) evolve continually, demanding increasingly strict criteria for assessing the materials of new drug products or medical devices.
By partnering with us for your extractables and leachables studies you'll stay up to date with changes in guidelines and industry requirements. We perform extractables and leachables testing that provides the data needed for your regulatory submission. Our scientists leverage regulatory expertise, decades of experience, and a strong extractables and leachables program, to evaluate potential risks and navigate a swift and efficient pathway to regulatory approval.
Unique challenges require in-depth knowledge
When choosing Element, your challenges become ours. Partner with us to share our decades of experience developing and executing extractables and leachables programs, one of the largest extractables databases in the industry, and the confidence that complex material assessments to toxicological evaluations are performed to the highest standards.
We have extensive experience testing a wide range of complex products including combination products, OINDP devices, cell and gene therapies and more. Our experts possess a deep understanding of ISO 10993-18 (a primary source of regulatory information for combination products and medical devices), to properly evaluate requirements and successfully design & deliver comprehensive extractables and leachables testing programs.
Costly delays and commercial impact
The primary goal of extractables and leachables studies is to ensure patient safety by identifying potentially harmful impurities. Failure to conduct appropriate testing may result in harmful organic and inorganic substances migrating into the finished product, compromising safety, effectiveness, and commercial success.
For an efficient commercial process, the qualification of extractables and leachables in early clinical development is critical. A thorough understanding of acceptable protocols and reports is also critical, following the wrong study protocol can result in costly delays.
Extractables and leachables testing services
- Customized extractables and leachables study designs according to industry best practices and regulatory guidance
- Development of extractables and leachables materials risk assessments and strategy documents
- Material selection for pharmaceutical container closure systems (CCS)
- Drug and container-closure compatibility studies
- Controlled extraction studies
- Complete method development and validation programs
- Extractable and leachable identification
- Leachable stability studies
- Toxicological safety assessments
- Comprehensive materials characterization and leachables risk evaluation according to ISO-10993 parts 18, 12 and 17
- Biocompatibility analysis for breathing gas pathways
- On-site training and consulting programs
- ISO 10993: Biological evaluation of medical devices (parts 18, 12, 17)
- ISO 18562: Biocompatibility evaluation of breathing gas pathways in healthcare applications
- USP <661>: Plastic packaging systems and their materials of construction
- USP <661.1>: Plastic materials of construction
- USP <661.2>: Plastic packaging systems for pharmaceutical use
- USP <665>, USP <1665>, (BPOG): Plastic components and systems used to manufacture pharmaceutical drug products and biopharmaceutical drug substances and products
- USP <1660>: Glass qualification
- USP <1663>: Extractables (pharmaceutical packaging/delivery systems)
- USP <1664>: Drug product leachables (pharmaceutical packaging/delivery systems)
- USP <381>: Elastomeric closures for injections
- Ph. Eur. <3.1.>: Materials used for the manufacture of containers
- Ph. Eur. 3.2 General sections on finished containers
- Ph. Eur. <3.2.9>: Rubber Closures for containers
Why Choose Element?
Partnering with us for extractables and leachables testing safeguards patient safety through accurate test data and delivering high-quality results. As one of the world's most experienced providers, ensuring regulatory compliance efficiency, expediting time to market, understanding complex study protocols, conducting tailored studies, and providing access to extensive expertise and experience in the field.
Our team of engaged experts has directly contributed to the industry for years, serving as active participants in several working groups that have developed the PQRI, USP Expert Panels, ELSIE, CEN and ISO extractable and leachable best practices.
For more information about our extractables and leachables studies and consulting services, or to request a quote, contact us today.
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.
Life Sciences Content
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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.READ MORE
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Extractables & Leachables Training Services
Element’s extractables and leachables training services address a wide range of topics in the industry to keep you up-to-date with the ever-changing regulations.
Extractables & Leachables Testing Reports
Element’s extractable and leachable testing programs are accompanied with clear, concise and accurate test reports.
Streamlining Extractables & Leachables Testing Protocols
Element helps you design effective and efficient extractables and leachables testing protocols to meet the risk-based approach and industry regulations.
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