Webinar: Origins and characterization of rubber leachables in medical devices and pharmaceuticals
Webinar ran: October 2018.
Download the recording and slides using the link at the bottom of the page.
Manufacturers of medical devices and pharmaceutical products need to acquire information on the substances that have the potential to leach from rubbers and be exposed to patients. These low molecular weight substances can originate from a large number of sources, including: Polymerization aids; Monomers and oligomers from the polymer; Oxidation products of the polymer; Plasticizers, process aids and species related to the filler system; Antidegradants and Cure system species and their breakdown products.
This webinar demonstrates how diverse the origins of these substances can be and shows how best to identify and characterize them.
The webinar
This will provide an overview of the chemical substances that may be expected from each source.In the case of species formed by reactions within the rubber, a background to the chemistry involved, descriptions of the types of analytical techniques and approaches that can profile these substances and case studies to illustrate the data obtained in screening studies.
Your presenters
Martin Forrest is a Principal Consultant in the Consultancy Group at Smithers and uses his extensive knowledge and expertise to provide clients with expert advice concerning food contact materials and medical devices. Martin also works with clients to achieve solutions to problems that cover a wide range of subjects, including material selection, failure investigation, performance optimisation and recycling.
Michael Creese manages Smithers' Extractables and Leachables (E&L) and Chemical Analysis consultancy team in the UK. He has been working with E&L for over 15 years both for Biopharmaceuticals and Pharmaceuticals, and joined Smithers in 2009. Michael has used his expertise to solve the challenges of the assessment of E&Ls for Single Use System suppliers and users (bags, tubing, filters, connectors etc.) and Final Container Closure Systems (pMDIs, stoppers, vials, pre-filled syringes, cartridges etc.).
Find out more about our medical and pharmaceutical testing services and our chemical characterization of polymers.
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