Medical device manufacturers must test their products for conformance to the relevant international quality standards. Additionally, internal QA checking to in-house specifications can help to optimise innovation and reliability. By upgrading their torque testing equipment to a software-controlled, motor-driven system, this drug delivery device producer was able to dramatically improve repeatability and reproducibility in their clean room procedures.
Global medical technology company BD (Becton Dickinson) needed to assess the torque required to twist off the cap of a drug delivery device. The test is performed as a manufacturing quality control measure. The company were using a manually operated torque tester, but experienced a large variation in results due to differing testing techniques between operators.
Mecmesin supplied BD with the Vortex-i computer controlled torque measurement system. The motorised operation of the Vortex-i eliminated the anomalous variability of results, enabling the company to confidently and accurately assess the conformance of this device to their rigorous in-house test standards. The simple and clear user interface allows BD operators to quickly and easily perform the test within their class 10000 clean room manufacturing environment. The test data is then exported from Emperor®, the accompanying software of the Vortex-i, into Microsoft® Excel for analysis and storage.
"The Vortex-i system has enabled us to eliminate the variability of results experienced with our previous manually-operated testing systems, allowing accurate and consistent testing of the conformance of our drug delivery systems to our stringent in-house standards."
Stephen Byrne BD Medical - Pharmaceutical Systems