Testing on Pen Injectors and Insulin Pens to DIN EN ISO 11608-1 to -3 

DIN EN ISO 11608-1, DIN EN ISO 11608-2, DIN EN ISO 11608-3

ZwickRoell offers the right testing system for your pen-injector and insulin-pen testing requirements

Insulin pen_automation

Quality Assurance Tests on Insulin Pens and Carpules to DIN EN ISO 11608-1 to -3

The most important requirements when testing medical products are the reproducibility of results and the minimization of operator influences. To meet these requirements, ZwickRoell 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 standard used for quality assurance tests on insulin pens and cartridges.

Image_Article Insulinpen automated

Automated testing of insulin pens

Together with an automated testing system, the zwickiLine materials testing machine with integrated torsion drive is a safe and cost-effective solution for testing insulin pens. Only one test fixture is needed to check a variety of insulin pen functions. 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 is responsible for automated 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. This minimizes the possibility of inaccurate test results due to operator influence. Our solution makes the test process significantly more efficient thanks to increased specimen throughput. It is also possible to manually test specimens at any time. 

testXpert III 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.