This expertise derives from Smithers Rapra's 90 year history of working with rubber and plastic materials, our medical and pharmaceutical industry experience and our excellent understanding of analytical chemistry.
The examination of Extractable and Leachable substances is extremely important for the protection of patients and for regulatory documentation destined for authorities such as the FDA and EMA. Find out more about Extractables and Leachables.
Smithers Rapra provides customised studies designed around your requirements
Smithers has a wealth of experience to share, to support our clients to effectively and efficiently develop, test, validate and document their products for qualification and regulatory submission. We understand that you have specific requirements that need to be addressed. Understanding E&L regulations, deciding on a suitable test strategy, and meeting timelines and resource restraints can be a challenge for those new to E&L. Because we know that decisions made early in an E&L study will affect later stages, we can guide you through what is required, and how best to meet your needs, to support your regulatory submission and protect patients.
What We Provide
Each stage of an E&L study is designed with you, to develop a customized service.
- Study plans and reports are provided throughout the life of the project.
- Our experts advise on the most appropriate programs of work and ensure that your regulatory requirements are fulfilled.
- Decades of expertise, meaning we:
- Understand Extractable and Leachable substances, their origins and degradation products
- Have developed in-house GC-MS, LC-MS and FT-IR library databases of many substances to aid in the identification of E&L substances
- Smithers Rapra has an open door policy and sponsors are welcome to visit our site and discuss any issues with us directly.
As material and E&L experts, we can offer our services on a purely consultative basis. We regularly support
For more information or to request a quote, please contact us.