The testing machine is equipped with a special test fixture for determining the breakaway force and glide force of syringes, carpules and similar drug-delivery systems. The glide-force test is based on the following standards: EN ISO 7886 -1, EN ISO 11499 and ISO 11040-4. The breakaway force and glide force are important parameters used to select the most suitable syringe. These forces may not exceed or fall below certain limits to ensure that a safe drug dose is administered.
Furthermore, tests to ISO 11040-4 (Prefilled syringes -- Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling) can also be performed.
"We decided to work with ZwickRoell due to the comprehensive consultation they provide throughout the entire duration of a project, their quick response times, and the overall solution. ZwickRoell not only fulfilled the demanding regulatory requirements to 21 CFR Part 11 and Annex 11 of the EU-GMP, but also proved they are truly a turnkey supplier by delivering a number of standardized test fixtures as well by supportively implementing customized solutions. The local service paired with a global presence provide a good foundation for a global partnership.“, states the manufacturer's laboratory manager.