Smithers Pira has recently added a new facility in Shawbury, UK to increase testing capacity for high-volume routine medical device tests ranging from product development to post-market auditing. Some of the testing techniques relate to the new compliance requirements related to European legislation for drug delivery devices. The new lab will support test methods such as leak detection, actuation assessments, dosage accuracy, tamper evidence assessments and connection compatibility among others.
Chris Berry, Ph.D., Manager, Medical Device Physical Testing will lead the team at the Shawbury laboratory. 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.
Relative to medical device package testing within the ISO 11067 guidelines, environmental conditioning is a major component. Smithers Pira’s Lansing, Michigan laboratory is in the process of adding more conditioning capacity to provide more flexibility and shorter lead times for clients who require temperature variations and multiple humidity conditions. The capacity expansion will be in place by March of 2017.
Smithers Pira’s sister company, Smithers Rapra, has been supporting the industry in the field of extractables and leachables testing of rubber and plastic materials used in medical devices and drug delivery devices for many years. With the addition of 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.
“The medical and pharmaceutical segments are a very important part of our testing business.”, said Dr. Jim Popio, vice president of Smithers Pira and Smithers Rapra in North America. “Investing in both capacity and the latest technologies goes a long way towards supporting our clients’ growth.”