The facility will be used for high-volume routine medical device tests ranging from product development to post-market surveillance.

The services will be in line with the new compliance requirements pertained to European legislation for drug delivery devices. 

Shawbury facility will provide different testing services, including leakage, ease of assembly, and actuation assessment, as well as simulated use and ease of use.

The facility will also offer services such as tamper evidence assessment, dose accuracy, verifications of product claims, visual inspections, dimensions and connection compatibility.

Smithers Rapra and Smithers Pira Europe vice president and general manager Sam Sheppard Fidler said: “The new laboratory is our latest investment in support of client demand in the medical device space.

“The expansion affords more capacity for high-volume testing, enabling us the potential to triple the number of tests we can perform.”

Smithers provides testing for rubber, plastics and composites, as well as chemical analysis, primary pack and shipment testing for medical devices.

The firm offers both standard and non-standard tests on a range of medical devices, accessories and packaging.

The tests will be provided for a range of devices such as metered dose inhalers (MDIs), needle-base injection systems (NISs), syringes and prefilled syringes, as well as transfusion and IV sets.

Image: Smithers has opened a medical device testing facility in UK. Photo: courtesy of Smithers Pira.