ZwickRoell will exhibit at the upcoming Pre-Filled Syringes West Coast Conference, June 3-4, at the Crowne Plaza San Diego in Mission Valley, CA, USA. The conference will host a global audience of medical device experts and pre-filled syringe industry leaders to discuss new developments and showcase the latest technologies in the industry.
Visitors to Booth 8 will have the opportunity to demo the zwickiLine single-column solution for the testing of pre-filled syringes to ISO 11040-4. ZwickRoell is the first materials testing machine manufacturer to offer a single solution that tests to the standard, offering interchangeable test fixtures that are ideal for various syringe types to ensure standardized testing.
Because glass syringes are typically used in connection with injection needles, Luer locks, adapters, and transfer devices, manufacturers are looking for a single solution to perform all of the required tests. With the zwickiLine testing system and interchangeable tooling, manufacturers are able to perform all ten ISO 11040-4 tests efficiently and accurately on one machine.”
Michael Goehring, ZwickRoell in North America’s Medical and Pharmaceutical Industry Manager
ZwickRoell will also have experts on hand to consult with conference participants on its semi-automated autoinjector, fully automated autoinjector, and pen injector testing solutions. Fully automated solutions range from easy-to-use smart robots only used for feeding and removing the injector to complex robotic systems, which are used to load specimens into multiple testing machines in parallel.
In addition, visitors to Booth 8 can demo testXpert III testing software, which allows for complete, tamper-proof documentation of all actions performed. The user defines the level at which actions are to be logged and explained according to his requirements. In individual cases, this may mean that each change made to a test-relevant parameter, such as test speed, is recorded in full. Together with the user management functions already integrated in testXpert III, this option provides the ideal tool for fulfilling the requirements from FDA 21 CFR Part 11 (regulation of the US Food and Drug Administration). Providing easy access to quality characteristics as well as protection from tampering at the same time allows manufacturers to optimize their processes and sustain improvements in product quality for safety-related products.