Tests on Pharmaceutical Pens / Insulin Pens

Important requirements when testing medical products are the reproducibility of results and the minimisation of operator influences.

To meet these requirements, Zwick has developed automated systems for testing pen injectors (for example, for insulin). Insulin therapy normally involves the subcutaneous injection of insulin by means of prefilled syringes or insulin pens. These pens are similar to writing pens and are filled with insulin cartridges.

Single-use pens are disposed of after the contents of the cartridge are dispensed, whereas reusable pens can be used year after year. DIN EN ISO 11608 Parts 1 to 3 is the applicable standard for quality assurance tests on insulin pens and cartridges. A testing system consisting of a zwickiLine table-top testing machine with additional torsion drive is used to test insulin pens.

This testing system can measure various pen functions, such as the dosage setting, actuation force, glide force, and specified dosage in one continuous process. You can modify and combine the test methods of both test axes to suit your testing needs. The testing system can perform these tests to check the pen’s mechanical function without the drug. Along with force and torque, it measures the activation force with the utmost precision. When testing filled prefilled pens, an integrated high-resolution scale is used to measure the dosing accuracy to DIN EN ISO 11608-1.

Automated testing of insulin pens

The zwickiLine materials testing machine with integrated torsion drive is a safe and cost-effective solution for testing insulin pens. You can check various insulin pen functions with only one test fixture.

This system allows you to measure the dosage setting, actuation force, glide force, and specified dosage in one continuous process. You can modify and combine the test methods of both test axes to suit your testing needs.

The roboTest R handling system facilitates specimen feeding. It uses the automation software AutoEdition2 to remove insulin pens from the magazine, feed them into the testing machine, and start the test, meaning test results are accurate because operator influence is minimised.

Zwick’s solution makes the test process significantly more efficient thanks to increased specimen throughput. It is also possible to manually test specimens at any time. The testing system can perform these tests to check the pen’s mechanical function without the drug.

Along with force and torque, it measures the activation force with the utmost precision. When testing filled prefilled pens, an integrated high-resolution scale is used to measure the dosing accuracy to DIN EN ISO 11608-1. The testXpert II testing software together with the expanded traceability option to FDA 21 CFR Part 11 make it possible to create documentation for the testing process that is complete and tamper proof.

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