Smithers expands capacity and capabilities to support the medical and pharmaceutical industries

Patient safety and overall performance is absolutely critical when considering the materials of construction and design of medical devices and pharmaceuticals. Device and pharmaceutical companies must ensure both product performance and regulatory compliance to meet the needs of the market. Smithers has recently added capabilities in extractables and leachables testing and other testing expansions to support these validation efforts.

medical and pharmaceutical capabilties expansionSmithers Rapra’s experts have been supporting the industry in the field of extractables and leachables testing for many years. Adding a Waters VionTM IMS QTof coupled with the Waters AQUITY UPLC I-Class, this Ion Mobility Quadrupole Time-of-Flight Mass Spectrometer (IMS QToF) provides state-of-the-art accuracy and rapid identification of extractable and leachable compounds. The ability of the system to generate mass data with a higher level of accuracy, along with information on fragment ions and the Collision Cross Section area (determined using the ion mobility), means that the molecular formula and structure of a compound can be quickly assigned, with the Collision Cross Section (CCS) data being used to provide an important additional dimension in the confirmation of an assigned molecular structure.

“Coupled with the knowledge and skills of our polymer and analytical experts, we will be able to provide even more in-depth and accurate testing on our clients’ products and packaging materials.”, said Andrew Feilden, chemistry operations director.

As part of the continuous development program, Smithers will expand its mass spectral database on extractable and leachable compounds and has committed to adding the collision cross section parameter to its library.

In addition to Smithers Rapra’s new E&L capabilities, sister company Smithers Pira has added a new facility in Shawbury, UK to expand testing capacity for high-volume routine medical device tests ranging from product development to post-market surveillance.  Many of these relate to the new compliance requirements related to European legislation for drug delivery devices.

The testing techniques that will be handled at the new Shawbury, UK facility include:

  • Leakage
  • Ease of assembly
  • Actuation assessment
  • Simulated use and ease of use
  • Dose accuracy
  • Tamper evidence assessment
  • Verifications of product claims
  • Visual inspections
  • Dimensions
  • Connection compatibility

Leading the team in Shawbury is Chris Berry, Ph.D., Manager, Medical Device Physical Testing. Dr. Berry has worked for Smithers for nine years and has previously served as Principal Scientist at the Smithers Pira Packaging and Technical Services laboratory located in Leatherhead, UK.