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
- Complete method 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.
Extractables & Leachables Regulatory Guidance Services
Element provides regulatory guidance services for extractables and leachables to ensure that medicines are of the required quality, safety, and efficacy.
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.
Excipient Raw Materials and Container Testing
Element has comprehensive capabilities that can be applied to the testing of excipient, raw materials, and pharmaceutical containers, enabling you to ensure the quality and safety of your product.
Medical Product Testing
With a clear understanding of your markets, regulations, and challenges, we provide our expertise and experience with cGMP, GLP, ISO/IEC 17025 testing to help your product reach the market sooner and with safety and quality built in.
USP <761> Qualitative and Quantitative NMR Analysis
Cathy Moore, Ph.D., provides an overview of NMR spectroscopy in this free recorded webinar to help you better understand the technology, data output, and capabilities of the method.
Microbiological Development and Quality Control Testing
Our microbiology lab provides microbiology testing services and quality control for a variety of drug products, ensuring they are safe, quality, and compliant with relevant regulatory standards.