To ensure that a safe drug dose is administered, the breakaway force/glide force (DIN EN ISO 7886 -1, DIN EN ISO 11499 and ISO 11040-4) of syringes must be tested. These are important parameters used to select the most suitable syringe and forces may not exceed or fall below certain limits. ZwickRoell will display its state-of-the-art zwickiLine testing system for the testing of syringes at the 2020 MD&M West Exhibition to be held in Anaheim, California at the Anaheim Convention Center February 11-13. Visitors to booth 446 will have the opportunity to demo the system and speak with subject matter experts about their applications.
“ZwickRoell has worked closely with the industry to develop a solution that addresses a wide variety of applications because syringes come in many shapes and sizes. The entire solution, from the testing machine and tooling to the testing software and extensometry, ensures reliable test results, which is critical in such a highly regulated industry,” explains Michael Goehring, Industry Manager for Medical and Pharmaceuticals.
ZwickRoell’s novel system features an adjustable specimen holder that can accommodate all common syringe geometries. Optional holders facilitate the testing of specimens without finger grips. ZwickRoell's testXpert III testing software makes it easy to test the maximum force and the average glide force. The integration of a weigh module makes it possible to determine the dosing accuracy of single doses, such as those in insulin cartridges. A camera documents the glide force of the syringe plug. The videoCapture plus option for testXpert III synchronously records the test results and the video signal. Together with the non-contact videoXtens extensometer, continuous measurement of the thickness of the plug is possible.
FDA 21 CFR Part 11 requires medical device manufacturers, pharmaceutical companies, biotech companies and other FDA-regulated entities to implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing electronic data that are required to be maintained by the FDA predicate rules or used to demonstrate compliance to a predicate rule. ZwickRoell offers a solution for maintaining full compliance with FDA 21 CFR Part 11 during the design and test of medical devices with its testXpert III measurement and control software.
The option for expanded traceability offers all tools required to fulfill the requirements set forth by the FDA in 21 CFR Part 11 in combination with organizational measures and procedural instructions in the respective company. The electronic records function within the testXpert software platform permits complete, tamper-proof documentation of all actions and modifications performed. The user defines the degree of actions to be logged and justified according to company specifications, which can originate from the company QM manual or external requirements. In a specific case, this could involve recording every change in a parameter relevant to testing, e.g. the test speed, in its entirety in an audit trail.
Further information on ZwickRoell testing solutions for medical devices may be found here: https://www.zwickroell.com/en/medical/therapy-systems/syringes