Reproducible test results and reduction of operator influence are essential when testing medical products. These requirements are well catered for by Zwick's fully automated system for insulin pen testing. A zwicki-Line materials testing machine with integrated torsion drive combined with a robotic handling system, provides reliable, cost-effective testing.
The system is based on a zwicki-Line Z0.5 TN table-top testing machine (Fmax 0.5 kN) with additional torsion drive (Mmax 2 Nm). This allows the various operations of the pen to be tested using a single device. The testing machine measures the dosage setting, injection force, stroke and plunger-rod thrust in one continuous process. Test methods on the two test axes can be modified and combined as required. If tests are to be performed with a cartridge installed, an optional laboratory scale that measures the insulin dose delivered can be fitted.
Automated specimen feed is via the 'roboTest R' handling system plus autoEdition2 automation software. The pens are fed into the testing machine from the magazine (capacity up to 50 specimens) and the test is started. Variation in test results caused by operator influence is eliminated and specimen throughput increased, making the test significantly more efficient; testing can however be performed manually at any time if required.
Used in combination with testXpertII testing software, the 'Expanded Traceability' option offers all the tools required to fulfil, in conjunction with organizational procedures and measures, the essential requirements stipulated by the FDA in 21 CFR Part 11 ('Electronic Records' and 'Electronic Signatures').