and Leachables
(E&L)
Comprehensive extractables and leachables testing to ensure product safety, regulatory compliance, and patient well-being.

A Trusted Partner in Extractables and Leachables Testing
Extractables and leachables (E & L) testing identifies chemical compounds that may migrate from medical devices or packaging into patients or drug products.
Broughton's extractables and leachables testing services provide clients with comprehensive analysis to identify potential contaminants that may migrate from packaging, container closure systems, or manufacturing processes into the final product.
Our experienced team conducts E&L studies under international regulatory guidelines, ensuring products are safe for their intended use.
Our Capabilities
Extractables Studies
Conducting controlled extraction studies to identify potential extractable compounds under exaggerated conditions.
Leachables Studies
Conducting simulated-use studies to detect compounds that may migrate into the product under normal storage and usage conditions.
Analytical Method Development and Validation
Developing and validating sensitive analytical methods to accurately detect and quantify extractables and leachables.
Toxicological Risk Assessment
Evaluating the safety of identified compounds through toxicological assessment to determine potential risks to patients.
Material Characterisation
Analysing materials used in packaging and manufacturing to understand their composition and potential to release harmful substances.
Regulatory Support
Providing comprehensive documentation and expert guidance to support regulatory submissions and compliance.
-resized.png)

Who We Support
Our E & L testing services are designed to meet the needs of a wide range of clients, ensuring that products are safe for their intended use and compliant with relevant regulations.
Industries we support include:
Why Broughton
Broughton provides E & L testing with scientific precision and regulatory confidence. Our team understands the critical role E&L studies play in ensuring product safety, supporting approvals, and protecting patients. Whether you require standalone testing or a fully integrated service, we deliver clear, actionable results aligned with your development goals.
Specialist Knowledge: Deep expertise in material science, analytical chemistry, and toxicologyRegulatory Alignment: Studies designed to meet the expectations of global health authorities
Flexible Study Design: Programmes tailored to product format, material type, and risk profile
Seamless Integration: Option to combine with toxicology consultancy, stability testing, or batch release for end-to-end support

Knowledge Centre
Explore More on Extractables and Leachables (E&L)