Therapy Systems

Therapy systems are drug delivery systems and injection devices with which drugs and pharmaceutical products can be administered in outpatient, hospitalized, and private situations. They include, among others, hypodermic syringes, injection needles, cannulae, infusion systems, pen injectors, and autoinjectors.

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Important tests in the area of therapy systems

Autoinjectors

ISO 11608-5 and ISO 11608-6

ZwickRoell offers test fixtures for tests on autoinjectors according to DIN EN ISO 11608-5 and wearable injectors (OBDS) according to ISO 11608-6.

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Autoinjector Spring Simulation

Simulation and characterization of spring forces and syringe glide forces

Spring forces have a significant influence on the success of injections using an autoinjector. Therefore, they must be measured accurately.

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Insulin pens and pen injectors

ISO 11608-1, ISO 11608-2, ISO 11608-3

Quality assurance tests on insulin pens and carpules to ISO 11608-1, ISO 11608-2, and ISO 11608-3 (also automated). These functional proficiency tests are referenced in USP 1382 and USP 382.

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Prefilled syringes

ISO 11040-4, ISO 11040-6, ISO 11040-8

Syringe testing to ISO 11040 with parts -4, -6 and -8 is critical for safe dispensing of medications, anticoagulants and biologics. To meet the strict requirements of the standard annexes, you need a testing system equipped with a variety of test fixtures.

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Test fixture to determine the breakaway force and glide force of syringes

Breakaway-/glide-force for syringes and carpules

DIN EN ISO 7886 -1, DIN EN ISO 11499, ISO 11040-4 and ISO 11608-3

The breakaway force and glide force are important parameters used in the selection of suitable syringes. The universal test fixture supports test according to standards DIN EN ISO 7886 -1, DIN EN ISO 11499, ISO 11040-4 and ISO 11608-3.

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Plunger glide force

ISO 7886-1; USP-Chapter 1382 and 382

The ZwickRoell testing software is used to record and evaluate plunger travel, breakaway force and the maximum and mean glide force. ISO 7886-1 is referenced in USP (United States Pharmacopeia) Chapter 1382 and 382.

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Tests on Luer systems/Luer lock connectors (ISO 80369-7, ISO 80369-20)

Luer system/Luer lock

ISO 80369-7 and ISO 80369-20

ISO 80369-7 and ISO 80369-20 are the standards used to test a Luer system or Luer lock connector for stability.

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Serial and parallel tests on syringe systems

Testing on syringe systems

If it is necessary to test a large number of syringes in a short time a materials testing machine with a carousel can be used. ZwickRoell offers the right testing system.

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