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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.

Important tests in the area of therapy systems

Autoinjectors
ISO 11608-5
ZwickRoell offers test fixtures for testing of autoinjectors to DIN EN ISO 11608-5.
to Autoinjectors
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.
to Autoinjector spring simulation
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.
to Insulin pens and pen injectors
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.
to Prefilled 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.
to Breakaway-/glide-force for syringes and carpules
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.
to Plunger glide force
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.
to Luer system/Luer lock
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.
to Testing on syringe systems
Break resistance of injection needles
ISO 9626
The break resistance of injection needles is determined to ISO 9626 using a 2-point flexure test.
to Break resistance of injection needles

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