A one-stop solution for all your extractables and leachables (E&L) needs. At Broughton, we deliver fully integrated E&L services combining advanced analytical testing with expert toxicological risk assessment. Our studies identify chemical compounds that may migrate from packaging, medical devices, or manufacturing processes into drug products or patients.
We take a structured approach—screening and prioritising substances of concern, then applying robust toxicological methods such as threshold of toxicological concern (TTC), read-across, and worst-case exposure modelling. All our work is aligned with international guidelines, including ICH, ISO, and PQRI, to ensure product safety, manage risk efficiently, and support compliance across the full development lifecycle.
A Trusted Partner in Extractables and Leachables Testing
Our Extractables and Leachables Testing service identifies compounds that may migrate from medical devices, packaging, or manufacturing processes into patients or drug products. Using a two-tiered approach - initial screening followed by detailed toxicological risk assessment - we ensure patient safety, effective risk management, and compliance with ICH, ISO, PQRI, and global regulatory frameworks.
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.
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 toxicology Regulatory 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
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