(Shropshire, UK) – January 11, 2021 - Smithers, a leading provider of testing, consulting, information, and compliance services, has completed an expansion of their Shawbury medical device testing laboratory. The UK-based Smithers location has been providing laboratory testing of medical devices and pharmaceutical products for over two decades.
This expansion comes as a response to increasing demand for Smithers medical device testing expertise. The laboratory is registered with the United States Food and Drug Administration (FDA) and works to Current Good Manufacturing Practice (cGMP) regulations.
The Shawbury facility features a chemical analysis laboratory and a physical and functional laboratory. The chemical analysis laboratory performs extractables and leachables testing programs designed to fulfil the global regulatory requirements for container systems and materials. Test programs follow USP, PQRI, and industry best practice. The physical and functional laboratory offers standard and non-standard medical device testing on a wide range of drug delivery devices, accessories, and packaging to ensure products are compliant and fit for use. Test programs follow ISO, ASTM, or Pharmacopeia.
The expansion increased Smithers capacity to provide their existing services while also providing the space needed to add new service offerings to medical device and pharmaceutical product manufacturers.
“As we continue to provide accurate data, on time, the demand for services from our Shawbury facility is increasing” says Gael Peron, Vice President, Smithers Medical Devices Testing Division. “The expansion enables us to accept new client projects while still maintaining the high standards for which we are known.”
Completed in November, the Shawbury expansion doubled the current infrastructure capacity for the laboratory and administrative functions. The new laboratory space is divided between the chemical and physical laboratories, while the new office space houses the facility’s growing workforce.
This is the second major expansion of Smithers Medical Device Testing Division in recent years. In 2020, a laboratory in Akron, Ohio was established. This facility, which mirrors the Shawbury location’s chemical analysis and physical and functional laboratories, is dedicated to providing testing services to companies based in North American and South America.
Smithers global support for medical device and pharmaceutical manufacturers includes:
- Material selection and evaluation
- Extractables and leachables testing
- Device physical and functional testing
- Shelf life studies
- Transit studies
- Failure and technical investigations
- Batch release testing
For more information on how Smithers works with clients, please get in touch with our experts.
Founded in 1925 and headquartered in Akron, Ohio, Smithers is a multinational provider of testing, consulting, information, and compliance services. With laboratories and operations in North America, Europe, and Asia, Smithers supports customers in the transportation, life science, packaging, materials, components, consumer, and energy industries. Smithers delivers accurate data, on time, with high touch, by integrating science, technology and business expertise, so customers can innovate with confidence.