The examination of extractable and leachable substances (such as plasticizers, antioxidants, stabilizers and dyes) is extremely important for the protection of patients and for regulatory documentation destined for authorities such as the FDA and EMA. Testing is conducted to ensure that the materials are not leaching into a pharmaceutical or from a medical device to a patient. Typically, the testing is done on rubber and polymer materials or components used in medical device and pharmaceutical packaging.
Smithers Rapra provides customized studies designed around your requirements
Smithers has a wealth of experience to effectively and efficiently develop, test, validate and document our clients' products for qualification and regulatory submission. We understand that you have specific requirements that need to be addressed. Understanding extractables and leachables regulations, deciding on a suitable test strategy, and meeting timelines and resource restraints can be a challenge for many companies. Because we know that decisions made early in an extractables and leachables 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.
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.
- Our expertise extends to:
- Understanding extractable and leachable substances, their origins and degradation products
- In-house development of GC-MS, LC-MS and FT-IR library databases of many substances to aid in the identification of E&L substances
In addition to our testing services, we can offer a wider range of supplementary services to support your team on a purely consultative basis. We regularly support:
For more information or to request a quote, please contact us.