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Testing of 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

Medical | Insulin pens and pen injectors | Quality assurance test
ISO 11608-1, ISO 11608-2, ISO 11608-3, USP 1383, USP 382
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 ISO 11608 1-3
Medical Industry | Autoinjectors
ISO 11608-5
ZwickRoell autoinjector testing systems enable the automated performance of all tests required by ISO 11608-5 on a specimen.
to Autoinjectors ISO 11608-5
An on-body delivery system lies on the test table for testing
Medical industry | On-Body Delivery Systems (OBDS)
ISO 11608-6
Testing on-body delivery systems (OBDS) is challenging. Find out about test requirements, typical test values, and key criteria for reliable test results.
to On-Body Delivery Systems to ISO 11608-6
Testing of prefilled syringes ISO 11040-4, ISO 11040-6, ISO 11040-8 - prefilled syringes
Medical | Syringes, prefilled | Test method for assessing integrity and functionality
ISO 11040-4, ISO 11040-6, ISO 11040-8, USP 1383, USP 382
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 Syringe testing ISO 11040
ISO 7886-1 Plunger glide force on single-use syringes, USP 1382 and USP 382
Medical | Syringes | Plunger glide force
ISO 7886-1, USP 1382, USP 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 ISO 7886-1
Tests on Luer systems/Luer lock connectors (ISO 80369-7, ISO 80369-20)
Medical | Luer/Luer lock connection
ISO 80369-7, 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 ISO 80369 Parts 7 and 20
Break resistance of injection needles to ISO 9626
Medical | Cannulas & needles | Break resistance
ISO 9626
The break resistance of injection needles is determined to EN ISO 9626 using a 2-point flexure test.
to Break resistance of injection needles ISO 9626
Flexible testing solutions for CDMOs
Testing Solutions for CDMOs
Flexible testing systems for CDMOs: from development to production.
to Testing Solutions for CDMOs
Testing injection systems: an important point when introducing injection systems
Testing concepts for injection systems
Successful introduction and testing of injections systems is based on various aspects. Proven solutions minimize risks; fail safe design prevents errors in testing injection systems. Find out more about the various factors here.
to Testing injection systems
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