| Cilag AG, Switzerland has been a member of the Johnson and Johnson group since 1961 and develops and markets innovative, high-quality pharmaceutical products and services aimed at improving quality of life for people with medical needs everywhere.
Although, it has been relatively easy to carry out testing of syringes with simple force testing machines in the past, Cilag realized that the current limitations of testing equipment with manual recorders was affecting the efficiency, and hence cost, of running their business. A common test requirement for the testing of syringes, stated in ISO 11040-4, is to measure the force exerted (indicated as the static and dynamic friction) and plunger travel whilst it is being pressed to expel a contained drug.
Cilag has obtained two systems (ten and eight active stations), both utilized as quality assurance within the production line, while one is additionally used for laboratory research.
In collaboration with Cilag AG, Zwick developed a fully automated and production integrated solution, which allows rapid testing of 10 pre-filled syringes at a time by utilizing a standard digital universal testing machine and adding a multi-axis configuration. Special tooling was integrated to hold the syringes, allowing rapid - yet very accurate - positioning of each syringe, and also including additional interchangeable holders for different syringe sizes. During the manufacturing process, syringes will be chosen and tested on the testing machine from Zwick. The testing results, static and dynamic friction, according to the standard, will be monitored as IPC (In-Process Control) and recorded variations from the required values will result in adjustments of the production process.
The second system, additionally used for laboratory research holds up to eight syringes. The software allows for more flexible user requirements and can be used to research syringe production.
For the operator, the test is simplicity itself as each syringe is placed in the special holder, the testing machine is started, and Zwick’s testing software testXpert® II takes over the complete test sequence. In addition, the software is able to analyze the data statistically, supporting the efficacy of data evaluation and batch review. The system is comprised of ten (eight, respectively) individual digital measuring channels, which allow the force to be read in and processed in real-time for each syringe. This data is synchronized with the plunger travel output from the digital crosshead encoder of the testing machine, and is shown graphically on the PC display. testXpert®’s graphic and data traceability capability allows all ten (eight, respectively) graphs to be shown in real time on the display. For test data traceability to the highest possible standard, the data is logged in accordance with FDA 21 CFR part 11. As the syringes are mostly pre-filled before testing, Zwick provided containers to catch the fluids expelled during the test.
Each force channel of the testing machine comprises a 200N (45lb) load cell with an accuracy class 0.5 according to the ISO7500-1 standard. This allows a wide certified range of testing down to small loads of less than 1N without needing to change load cells. In addition, the current value of all ten (eight, respectively) load cells can be seen on the on-screen digital display in real-time whilst the machine is at rest or during the actual test.
As part of its global operations, Cilag AG wanted to report the test results in different languages. So with testXpert®’s unique on-line language switching facility, the operator can perform the test using his own local language and the report can be selected in another language before being transmitted to the recipient.
Through the repetitive selection of Zwick systems for applications in the medical industry, Cilag AG confirms Zwick’s strength in testing technology and service. |
