Extractables & Leachables Studies

Element’s extractables and leachables studies offer tailored solutions that shorten time to market and ensure patient safety and the sustainability of your pharmaceutical and medical device products.

Studying the impact of extractable and leachable substances on safety and drug product interaction is of utmost importance to protect the patient and comply with regulations. Leachable materials may originate from pharmaceutical container closure systems, process equipment or medical device packaging, and go on to contaminate the drug before consumption.

Element's E&L teams use industry-leading expertise, in-depth knowledge of materials and regulatory requirements to help customers assess the potential for leachables, develop strategies to evaluate risk and provide a solid risk-based set of supporting data.

From materials assessment through toxicological evaluations, extractables and leachables testing and everything in between, Element supports the world’s leading healthcare brands in establishing the safety of materials for patients.

Extractables and leachables study programs

• Container closure systems (CCS), including combination products
• Single-use manufacturing equipment, including BPOG protocol
• Implantable medical devices
• Drug delivery and infusion systems

Our advanced equipment, in-depth knowledge of materials and regulations result in the efficient and successful completion of E&L testing programs for pharmaceutical packaging and manufacturing equipment.

Extractables and leachables study services

• Material selection for pharmaceutical container closure systems (CCS) and medical devices
• Customized E&L study designs developed according to the latest industry best practices
• 完整的方法development and validation programs
• Toxicological safety assessments
• Development of E&L materials risk assessments and strategy documents suitable for regulatory submission
• Comprehensive materials characterization and leachables risk evaluation according to ISO-10993 parts 18, 12, and 17
• On-site training and consulting programs

We combine our Good Manufacturing Practice (cGMP) compliant laboratories with years of experience and state-of-the-art testing equipment to offer the efficient and successful completion of E & L testing programs for pharmaceutical packaging, manufacturing equipment, and medical devices.

The Element advantage

Element's laboratory complies with Good Manufacturing Practice (cGMP) guidelines. Our team of Engaged Experts have been active participants in several working groups that have developed the PQRI, USP Expert Panels, ELSIE, and BPOG extractable and leachable best practices.

Our extractables and leachables studies help make certain the quality and effectiveness of the drug product are maintained at all times, in all circumstances, while at the same time meeting all relevant regulatory requirements.

For more information about our extractables and leachables studies or to request a quote,contact us today.