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

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.

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  • Industry brochure: Medical PDF 6 MB

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.

Dose accuracy to DIN EN ISO 11608-1

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. 

Testing the pen power pack

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 pens, an integrated high-resolution scale is used to measure the dosing accuracy to DIN EN ISO 11608-1. 

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 AutoEdition3 automation software 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. 

We look for and find the optimal testing solution for every one of your requirements.

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Related products to testing of pen injectors and insulin pens

Traceable, tamper-proof test results in accordance with FDA 21 CFR Part 11

Traceable tamper-proof test results
  • Ever-increasing demands are placed on software used in the medical and pharmaceutical industries to document the traceability of completed actions.
  • With the traceability option, testXpert III enables logging of all actions and changes before, during and after the test, making test results and the documentation traceable and protecting them from manipulation.
  • Integrated user management and functions such as electronic records and electronic signature ensure that test results are always protected from tampering.
  • Together with the organizational measures and procedure instructions that apply to the individual companies themselves, the requirements of FDA in 21 CFR Part 11 are fulfilled.
  • ZwickRoell also offers a qualification service package (DQ/IQ/OQ) for validation support.
  • testXpert III logs all test and system related actions and settings and can therefore always answer the question “When does who do what, why and who is responsible?” 

Learn more about the testXpert III option
Traceability

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