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Test Tools for the Medical Industry

Autoinjector testing system – AllroundLine 5 kN

Autoinjector testing system – AllroundLine 5 kN

Range of application
Standards
Traceability and reliable test results for electronic records in testXpert III
testXpert III testing software

Range of application

Autoinjectors and pens used for the subcutaneous administration of medications, represent a fast-growing market segment of medical products.

To ensure that these devices function reliably and safely, they must be thoroughly tested by both autoinjector manufacturers and pharmaceutical companies, who fill them. For this purpose, reproducibility and traceability of test results, as well as reduced operator influences are of critical importance.

Standards

The following standards are met:

  • ISO 11608: Needle-based injection systems for medical use - requirements and test methods; Part 5: Automated functions
  • DIN EN 13849-1: Safety of machinery control systems

Traceability and reliable test results for electronic records in testXpert III

With the 21 CFR Part 11, the FDA specifies requirements on electronic records and signatures. The ZwickRoell whitepaper accurately describes the scope of the option in testXpert III. It enables logging of actions and changes before, during and after the test, making test results traceable and protecting them from tampering.

The traceability option can be configured as needed, and the degree of traceability can be defined. The logging entries are stored (automatically and according to type) in the system audit trail or in the relevant test program/test series.

testXpert III testing software

The software package for autoinjectors with the following components tests/options:

  • Results Editor
  • Layout Editor
  • Report Editor
  • Export Editor
  • Organization Editor
  • Virtual testing machine VTM
  • Traceability for electronic records to FDA 21 CFR Part 11

The test program for autoinjectors with the following components tests:

  • Measurement of the pull-off force of the safety cap
  • Measurement of the activation force of the needle shield
  • Measurement of the injection depth
  • Measurement of the injection time
  • Measurement of the weight of the fluid and calculation of the volume of medication
  • Verification of the needle shield locking mechanism after activation
  • Visual documentation of the injection process

The zwickiLine autoinjector testing machine is designed for injector types with actuation via needle shield

The testing system for autoinjectors consists of these three main components:

  • zwickiLine 2.5 kN materials testing machine with injector test fixture and XForce load cell
  • testControl II machine electronics and measurement and control unit
  • Software package for testing autoinjectors and injector-specific test programs

Performance range of the autoinjector testing system

The following tests and measurements can be performed with the autoinjector testing system

  • Measurement of the pull-off force of the safety cap
  • Measurement of the release force via the needle shield
  • Measurement of the injection depth
  • Measurement of the injection time
  • Measurement of the weight of the fluid and calculation of the volume of medication, incl. the last drop
  • Checking of the activated needle shield after the injection has been performed

zwickiLine autoinjector testing machine

zwickiLine autoinjector testing machine

Target-oriented and focused
Special features and functions

Target-oriented and focused

The zwickiLine testing machine is an easy to operate testing system ideal for testing autoinjectors in the field of R&D, and for customers with reduced requirements in terms of throughput, but with high quality demands in the medical and pharmaceutical industry. The focus of its performance range was based on the established, semi-automatic autoinjector testing machine, the AllroundLine 5 kN. It includes the basic tests of functions for autoinjectors (see performance range).

The machine offers the proven operating concept with comparable results on a small footprint. and an overall cost-optimized solution.

Special features and functions

  • Testing of injectors with actuation via needle shield
  • Testing of all functions with a single specimen
  • Small footprint of the testing system
  • Fast cycle times
  • Reduced test times for component tests and the complete sequence
  • testXpert III traceability ensures data integrity according to FDA 21 CFR Part 11.
  • The last drop of the injection is therapeutically relevant and is weighed during the test sequence and included in the result calculation.
  • Reliable test results by avoiding anti-static influences on weighing results
  • Removal of the injection-related spray mist allows for reliable detection of the injection depth/time, thereby guaranteeing reliable test results
  • DQ- IQ-OQ – qualification of installation and work processes
  • Removal of the last drop of the injection allows for clear recognition of the needle tip, thereby guaranteeing reliable test results
  • The electrically interlocked safety door protects the user from possible injury risks

Traceable and tamper-proof test results

All safety-critical tests, such as those in the pharmaceutical and medical engineering industries, have special requirements on traceability and documentation. testXpert III ensures that the test results are always protected against tampering and that all changes and test results are traceable.

Learn more about traceability in testXpert III

Test fixture for determining breakaway force and glide force

  • Applications: Tests on hypodermic syringes, carpules and similar drug delivery systems to determine the forces on the cap (breakaway force, glide force). The glide force test is based on the following standards: DIN EN ISO 11499 and ISO 11040-4.
  • Specimen material: syringes, carpules, similar drug-delivery systems
  • Function description: The test device is used to determine the forces on the caps of hypodermic syringes, carpules and similar drug-delivery systems. It consists of a clamping fixture, a die and a beaker. The fluid-filled specimen is gripped in the holding fixture. The die moves the specimen piston down. Its concave seat ensures that the piston is centered. Swiveling guide jaws with two different radii ensure optimal guiding. The liquid is expelled downwards and is collected in the beaker.
  • Advantages:
    • Customized holders can easily be attached.
    • Device has apertures for visual monitoring of glide path.
    • Insertion and removal of specimens occurs via a quick release fastener. The specimen diameter setting is maintained.
    • Adjustable specimen holders allow all established specimen geometries to be used. Specimen diameter adjustment is performed steplessly and tool-free via a handwheel.
    • Cartridge holders available as an option for standard sizes 1.5 ml and 3.0 ml.
    • testXpert III makes it possible to connect to an optional scale.

Fixture for testing syringe plunger force

  • Applications: The test fixture is used to determine the plunger glide force of sterile single-use syringes made from plastic and other materials for medical purposes, with fluid contents (water) to EN ISO 7886-1 Annex E (2017).
  • Function description: The test fixture consists of an upper and a lower clamping device to hold the syringe and a height-adjustable fluid reservoir. When testing, the plunger rod of the syringe can be loaded in both tensile and compression directions.

    During the test, the fluid in the filled syringe is expelled into the reservoir via a standard needle (18G). The needle is connected to the hose via a Luer connector. During the test, the plunger travel, the breakaway force, as well as the maximum and the average glide force are recorded and evaluated via ZwickRoell testing software. The test speed is 100 ±5 mm/min.

  • Advantages:
    • The fixture includes all components required by the standard (holders, reservoir, hose with adapters).
    • The clamping devices accommodate syringes with a diameter of 6 to 33 mm
    • High accuracy
    • ZwickRoell's testing software combined with the Traceability option fulfills the requirements according to the ZwickRoell FDA 21 CFR Part 11 whitepaper

Mounting for attaching injection needles

  • Applications: Holder with Luer taper for retaining injection needles and other connectors. For penetration tests on films or skin substitutes to ISO 11040-4 and for fragmentation tests on bottle closures.
  • Advantages:
    • Standard holder for connecting to various medical engineering components
    • Fast change of needles and connectors with Luer cone
    • ZwickRoell's testing software combined with the Traceability option fulfills the requirements necessary for compliance with all FDA 21 CFR Part 11 criteria

Needle puncture test fixture

  • Applications: The needle puncture test fixture is used to determine the puncture force of needles to ISO 11040-4. Typical medical applications are, for example, puncture tests on skin replacement material or penetration tests on standard films.
  • Function description: The needle puncture test fixture consists of a base body with a swivel able specimen holder.

    The material to be punctured is gripped in the specimen holder. The test angle can be set to four different angles by means of a lock-pin.

  • Advantages:
    • Variable test angle to test axis; can be locked at 30 °, 45 °, 60 ° and 90 °
    • Needles with a diameter up to 8 mm or injection needles and other connectors with Luer cones can be mounted in the optionally available holders
    • ZwickRoell's testing software combined with the Traceability option fulfills the requirements necessary for compliance with all FDA 21 CFR Part 11 criteria

Medium container

  • Applications: Typical applications for fluid baths in the medical industry include testing of stents, biological materials, dental ceramics, suture material.
  • Function description: The medium container for medical tests can be filled with mediums such as physiological saline solution, or salt solutions with buffered pH value.

    The container can be moved away from the liquid medium axially to enable the specimen to be gripped. Various test tools or specimen grips can be connected at the mounting stud on the connecting rod.

  • Advantages:
    • Glass container can be moved axially with spring support to enable clamping of the specimen outside the liquid medium
    • Includes collection trough and hose connection for draining the liquid.
    • Various test tools or specimen grips can be connected to the mounting stud located inside the bath
    • Quick dismantling for easy cleaning; disinfection also possible in autoclave up to 120°C
    • The Traceability option in the testXpert III testing software sets the necessary requirements to satisfy all criteria of FDA 21 CFR Part 11.
    • A flexure test kit for tests based on DIN EN ISO 6872 is available specifically for medical applications, together with specimen grips for use in liquids.
    • Optional temperature conditioning device (ambient temperature up to 80°C) for installation in the fluid bath including a separate container for preconditioning the specimen.
    • Optional use of videoXtens optical extensometer

Test tools for testing glass syringe barrels to ISO 11040-4 and ISO 11040-8

In the standard ISO 11040-4 and -8 (Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling) the following tests are defined:

  • C1 - Flange breakage resistance
  • C2 - Luer cone breakage resistance
  • E - Glide force test method to evaluate syringe lubrication
  • F - Needle penetration test
  • G1 - Needle pull-out force
  • G2 - Closure system liquid leakage test
  • G3 - Luer lock adaptor collar pull-off force
  • G4 - Luer lock adaptor collar torque resistance
  • G5 - Luer lock rigid tip cap unscrewing torque
  • G6 - Pull-off force of the tip cap or the needle shield

ZwickRoell has a complete portfolio of products to satisfy the requirements of ISO 11040-4 and -8. The interchangeable test fixtures are ideal for various syringe types and ensure that the testing of prefilled syringes is standardized. The modular design allows test fixtures to be used for various tests.

ZwickRoell's testing software combined with the Traceability option fulfills the requirements necessary for compliance with all FDA 21 CFR Part 11 criteria. Corresponding Standard Test Programs can be found in section 5, System catalog for testing software.

The tests defined in Annexes G4 and G5 include torsion testing and can therefore be found in the Projects division portfolio.

The fixtures required to satisfy the testing requirements are described below, followed by a selection chart for rapid specification.

ISO 11040-4 Annex C1 - Finger flange breakage force

  • Applications: The test fixture is used to determine the breakage force of the finger flange of prefilled syringes. In Annex C1 of the standard the breakage resistance of the finger flange is tested. To perform the test the glass syringe is inserted into the support disc of the universal mount. 
  • Advantages:
    • The same test fixture can also be used for Annex E and G2
    • Adjustable mount for different syringe volumes with varying diameters and lengths
    • Quick-release fastener for fast specimen changes

ISO 11040-4 Annex C2 - Luer cone breakage resistance

  • Applications: Testing is performed on glass syringe barrels for injectables and sterilized subassembled syringes ready for filling. In Annex C2 of the standard the breakage resistance of the Luer cone is tested. To perform the test the glass syringe is inserted into the retaining cylinder of the syringe holder. Correct positioning of the syringe is set with the integrated limit stop adjustment slide. A compression die is used to apply force to the Luer cone until it breaks.
  • Advantages:
    • Adjustable syringe mounting for different syringe diameters and lengths
    • Quick-lock system for secure holding
    • Reproducible distance setting for syringe

ISO 11040-4 Annex E / G2 - Syringe glide force / liquid leakage test

  • Applications: Testing is performed on glass syringe barrels for injectables and sterilized subassembled syringes ready for filling. In Annex E of the standard the glide force of the syringe without protective cap is tested.

    Annex G2 describes the leakage test on a filled syringe with attached protective cap. The plunger is pressed to the shoulder of the syringe at a defined force and speed.

  • Advantages:
    • The same test fixture can also be used for Annex C1
    • For syringes with Ø 6 / 8,2 / 11 mm
    • Adjustable syringe mounting for different syringe diameters and lengths
    • Quick-lock system for secure holding

ISO 11040-4 Annex F - Needle penetration force

  • Applications: Testing is performed on glass syringe barrels for injectables and sterilized subassembled syringes ready for filling. Annex F describes the needle penetration test with special film that has properties similar to human skin.

    To perform the test, the glass syringe is inserted into the upper pneumatic specimen grip, which is closed with the foot control. The protective cap is pulled off the syringe. Downward movement of the crosshead causes the needle to penetrate the film.

  • Advantages:
    • Variable test angle to test axis that can be locked at 30°, 45°, 60° and 90°
    • Versatile pneumatic grips that can also be used for Annex G1, G3 and G6
    • Secure gripping of sensitive specimens through adjustable gripping pressure
    • Optional pneumatic control unit to open and close the specimen grips

ISO 11040-4 Annex G1 - Strength of needle bonding

  • Applications: Testing is performed on glass syringe barrels for injectables and sterilized subassembled syringes ready for filling. In Annex G1 of the standard the strength of the needle bonding (needle pull-out force) is tested.

    To perform the test, the glass syringe is gripped with the lower pneumatic grip. The aligned syringe needle is gripped with the special jaws of the upper pneumatic grip and pulled off upwards at a defined speed.

  • Advantages:
    • Versatile pneumatic grips that can also be used for Annex F, G3 and G6
    • Special corrugated jaws with plane surfaces for optimum load application
    • Secure gripping of sensitive specimens through adjustable gripping pressure

ISO 11040-4 Annex G3 - Pull-off force of Luer lock rings

  • Applications: Testing is performed on glass syringe barrels for injectables and sterilized subassembled syringes with Luer lock ring ready for filling. In Annex G3 of the standard, the pull-off force of the Luer lock rings is measured.

    To perform the test, the glass syringe is gripped with the lower pneumatic grip, Fmax 500 N. The Luer lock ring is pulled axially upwards off the glass syringe with the self-aligning tension grips. The test speed is 20 mm/min.

  • Advantages:
    • Versatile pneumatic grips that can also be used for Annex G1, G4 and G6
    • Special self-aligning tension grips for different Luer lock adapter sizes
    • Secure gripping of sensitive specimens through adjustable gripping pressure

 

ISO 11040-4 Annex G6, Method 1 - Pull-off force of needle shield (tip cap)

  • Applications: Testing is performed on glass syringe barrels for injectables and sterilized subassembled syringes ready for filling. In Annex G6 of the standard, the pull-off force of the needle shield (tip cap) is measured. To perform the test, the glass syringe is gripped with the lower pneumatic grip, Fmax 500 N.

    The needle shield (tip cap) is pulled axially upwards off the glass syringe with the 3-Jaw chuck. The test speed is between 100 mm/min and 1000 mm/min. The pull-off force and the pull-off distance are measured and recorded.

  • Advantages:
    • Versatile pneumatic grips that can also be used for Annex F, G1, G3, G4 and G5
    • Secure gripping of sensitive specimens through adjustable gripping pressure

ISO 11040-4 Annex G6, Method 2 - Pull-off force of needle shield (tip cap)

  • Applications: Testing is performed on glass syringe barrels for injectables and sterilized subassembled syringes ready for filling. To perform the test, the glass syringe is gripped with the lower pneumatic grip, Fmax 500 N.

    The needle shield (tip cap) is pulled axially upwards off the glass syringe with the self-aligning tension grips. The test speed is between 100 mm/min and 1000 mm/min. The pull-off force and the pull-off distance are measured and recorded.

  • Advantages:
    • Special self-aligning tension grips for different needle shield sizes
    • Secure gripping of sensitive specimens through adjustable gripping pressure

Fixture for determining the residual seal force (RSF)

  • Applications: Indirect residual seal force on medical vials. This includes the residual seal force (RSF) is the force with which the rubber stopper between the flanged cap and the neck of the vial is braced. This force measurement indicates the security of the vial closure. However, these measurements must be correlated with established tests that examine the seal integrity of the stopper.
  • Advantages:
    • The fixture consists of a retaining plate for supporting the vial. The integrated prism serves as a centering aid with a scale used to read a vial diameter of 6 mm to 70 mm.
    • Fixture available with inserts and compression dies of various diameters (8.0 mm; 13.8 mm; 20.7 mm; 28.5 mm; 32.94 mm). For the respective test, the die diameter should correspond with the protective cap diameter.
    • A modular design allows the various inserts to be changed quickly and easily.
    • an upper compression test kit with locking nut for pre-positioning the die holds the compression die.
    • Load is applied via a ball joint to compensate for deviations from parallel up to approximately 1°.
    • Collection tray for liquid.
    • Use only in conjunction with a safety device.

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Medical/Pharmaceutical

Quality assurance in the medical engineering and pharmaceutical industry places the highest demands on testing technology in terms of hardware, software, and documentation. ZwickRoell has the knowhow and the testing solutions to meet these demands.
to Medical/Pharmaceutical

Insulin pens and pen injectors

ISO 11608 1-3
Quality assurance tests on insulin pens and carpules to DIN EN ISO 11608-1 to -3 (also automated).
to Insulin pens and pen injectors

zwickiLine The Perfect Testing System for Medical Engineering

Small footprint, big range of application – the new zwickiLine is the ideal testing machine for medical engineering and the pharmaceutical industry. The combination of an innovative operating concept and state-of-the-art drive technology with powerful, flexible electronics allow these testing machine ranges to cover a wide range of varied applications.
to zwickiLine The Perfect Testing System for Medical Engineering

Autoinjectors

ISO 11608-5
ZwickRoell offers test fixtures for testing of autoinjectors to DIN EN ISO 11608-5.
to Autoinjectors

Downloads

Name Type Size Download
  • Product information: Autoinjector testing system PDF 501 KB
  • Product information: Test fixture for determining breakaway force and glide force PDF 343 KB
  • Product information: Fixture for testing syringe plunger force PDF 595 KB
  • Product information: Test fixture for determination of plunger actuation force – version 2 PDF 666 KB
  • Product information: Mounting for attaching injection needles PDF 98 KB
  • Product information: Needle puncture test fixture PDF 3 MB
  • Product information: Medium container PDF 469 KB
  • Product information: ISO 11040-4 Annex C1 - Finger flange breakage force PDF 2 MB
  • Product information: ISO 11040-4 Annex C2 - Luer cone breakage resistance PDF 571 KB
  • Product information: ISO 11040-4 Annex E / G2 - Syringe glide force / liquid leakage test PDF 263 KB
  • Product information: ISO 11040-4 Annex F - Needle penetration force PDF 136 KB
  • Product information: ISO 11040-4 Annex G1 - Strength of needle bonding PDF 2 MB
  • Product information: ISO 11040-4 Annex G3 - Pull-off force of Luer lock rings PDF 3 MB
  • Product information: ISO 11040-4 Annex G6, Method 1 - Pull-off force of needle shield (tip cap) PDF 4 MB
  • Product information: ISO 11040-4 Annex G6, Method 2 - Pull-off force of needle shield (tip cap) PDF 3 MB
  • Product information: Fixture for determining the residual seal force (RSF) PDF 222 KB
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