Extractables and Leachables Testing Services
Partner with our experienced team for extractables and leachables testing to identify harmful impurities and protect your patients. Our risk-based approach to extractables and leachables studies ensures regulatory compliance while expediting your time to market. With decades of expertise in pharmaceutical, medical device, and biological products, we'll guide you through complex regulatory requirements.
What is Extractables and Leachables Testing at Element?
Extractables and leachables testing identifies potentially harmful impurities that may migrate from polymeric materials into pharmaceutical, medical device, biologic, and combination products. At Element, we provide comprehensive testing using aggressive laboratory conditions for extractables studies to provide an early indication of potential risk and support materials selection during development, and leachables testing to detect chemicals that migrate under typical-use conditions, ensuring both regulatory compliance and patient safety.
What Can Element Offer You For Extractables and Leachables Testing Services?
Key tests offered
Key tests offered
Our comprehensive extractables and leachables testing services deliver the specific data you need for regulatory submission while supporting your product development decisions.
- Controlled extraction studies
- Simulation extraction studies
- Extractable identification
- Leachable stability studies
- Materials characterization
- Leachables risk evaluation
- Toxicological safety assessments
- Biocompatibility analysis for breathing gas pathways
Components and materials we test
Components and materials we test
We test a wide range of components that come into contact with your products, from container closure systems to manufacturing equipment. Our expertise covers polymeric materials, elastomeric closures, glass containers, single-use processing systems, and custom drug delivery devices. We understand the unique challenges of each material type and apply appropriate methodologies to accurately assess potential risks.
- Container closure systems
- Manufacturing and process equipment
- Packaging components
- Delivery devices
- Medical devices
- Single-use processing systems
- Custom drug delivery systems
Methods and solutions offered
Methods and solutions offered
Our process follows a structured approach: First, we assess risk by reviewing all materials to define scope. Next, we ascertain extractables using appropriate solvents to identify compounds that could potentially become leachables. We then determine toxicology risk through comprehensive studies. For the final product, we target and quantitate harmful leachables to determine actual risk. Finally, we provide detailed feedback to help you comply with standards and reduce market delays.
Our approach combines scientific expertise with regulatory knowledge to create customized solutions that meet your specific needs while ensuring compliance.
- Customized extractables and leachables study designs
- Materials risk assessments and strategy documents
- Method development and validation programs
- Drug and container-closure compatibility studies
- Complete extractables and leachables study execution
- Comprehensive reporting with clear interpretations
- Regulatory guidance and submission support
- On-site training and consulting programs
Industry Leadership and Expertise
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. This involvement ensures our testing protocols reflect the latest industry standards and regulatory expectations.
Cutting-edge equipment we use
Cutting-edge equipment we use
We operate state-of-the-art analytical equipment in compliance with Good Manufacturing Practice (cGMP) and Good Laboratory Practice (GLP) quality systems. Our extensive libraries facilitate the identification of extractables and leachables, allowing for comprehensive analysis and accurate risk assessment.
Which labs offer this service
Which labs offer this service
Our team operates from Life Sciences hubs across the world, providing global access to our expert capabilities. Find your nearest Life Sciences hub on our Locations Page.
Standards we test to and materials we test
- ISO 10993: Biological evaluation of medical devices (10993-18, 10993-12, 10993-17)
- 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 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
Pharmaceutical Packaging Components
- Container closure systems
- Plastic packaging materials
- Elastomeric closures
- Glass containers
- Rubber stoppers
- Vials and bottles
- Prefilled syringes
- Blister packs
Manufacturing and Process Equipment
- Single-use processing systems
- Tubing and connectors
- Filters
- Bioprocessing materials
- Production line components
Medical Devices and Delivery Systems
- Inhalers and respiratory devices
- Custom drug delivery systems
- Injectable devices
- Implantable devices
- Combination products
- OINDP devices
Your Challenges, Our Solutions
Complex Regulatory Requirements
Patient Safety Concerns
Market Entry Delays
Protocol Development Complexity
Why Choose Element
World-Leading Experience
Regulatory Navigation Expertise
Global Testing Network
Complex Product Specialists
Frequently asked questions
What is the difference between extractables and leachables testing?
Extractables testing uses aggressive laboratory conditions to extract compounds that could potentially migrate, providing early indication of risk during materials selection and development. Leachables testing detects chemicals that actually migrate into the product under typical-use conditions, testing the finished drug product or medical device.
Why is a risk-based approach important for E&L testing?
A risk-based approach is expected by regulatory agencies and ensures efficient resource allocation. Lower risk dosage forms, such as oral and topical products, may not require formal E&L testing if materials comply with FDA food contact regulations, while higher-risk products need comprehensive assessment.
What happens if I don't conduct appropriate E&L testing?
Failure to conduct appropriate testing may result in harmful organic and inorganic substances migrating into your finished product, compromising safety, effectiveness, and commercial success. This can lead to costly regulatory delays, product recalls, and potential harm to patients.
What types of reports do you provide for E&L studies?
We provide two types of reports: Extractables and Leachables Materials Assessment (describing justification for study protocol) and Extractables and Leachables Testing Report (outlining testing goals, methods, and results). Our reports are clear, concise, accurate, and fully interpretative.
What are Element’s credentials in E&L testing?
Our experts have decades of E&L experience and knowledge and are active in standards development. As they help shape industry best practices, they apply this cutting-edge knowledge to our customers’ studies. Element has one of the largest and most comprehensive extractables reference library in the industry. Our customers leverage our extensive specialized testing expertise for complex products, including OINDP, combination products, and cell therapies.
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