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Autoinjector testing systems

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Versions
  • AllroundLine 5 kN zwickiLine 2.5 kN
Special feature
  • Multifunctional platform DailyChecks for all sensors PokaYoke error prevention For different types of autoinjectors Comprehensive performance range 21 CFR Part 11 requirements
Standards
  • ISO 11608-5 DIN EN 13849-1

Autoinjector testing systems from ZwickRoell: reliable test results guaranteed

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.

ZwickRoell offers two types of autoinjector testing systems:

  • AllroundLine autoinjector testing system with actuation via needle shield and actuation button
  • zwickiLine autoinjector testing system with actuation via needle shield

Features of the autoinjector testing systems

Features of the autoinjector testing systems

AllroundLine 5 kN vs. zwickiLine 2.5 kN
Properties of the AllroundLine
Properties of the zwickiLine
Standard compliance
Testing assistant roboTest N
Robotic testing system roboTest R
Traceable and reliable test results

AllroundLine 5 kN vs. zwickiLine 2.5 kN

AllroundLine 5 kN:

The AllroundLine materials testing machine is ideal for autoinjector test requirements.Forschungsprojekte.

zwickiLine 2.5 kN:

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 function tests for autoinjectors and is actuated via a needle shield.The machine features the proven operating concept with comparable results on a small footprint.In addition, it is an overall cost-optimized solution.

Properties of the AllroundLine

  • The multifunctional materials testing machine provides a high level of flexibility by allowing for the performance of all components tests on autoinjectors:
    • One specimen for all function tests; all values are created in one cycle
    • One results file for all function tests:Reproducibility
    • Cost reduction due to reduced number of specimens
    • Prevention of human error through sequential process and a single specimen
  • Modular design of the testing system for higher flexibility in terms of expansion and service
  • Faster cycle times (< 3 min)
  • Semi-automatic testing of autoinjectors for avoid operator errors
  • Convenient expansion options for fully automated feeding of specimens using robotic systems
  • Guaranteed reliable test results achieved through Daily Checks for force, weight, injection depth, fluid and acoustics
  • Operation via PC or remote control:Supports ergonomic and efficient operation of the testing system
  • DQ- IQ-OQ – qualification of design, installation and work processes
  • Synchronous visual documentation of the injection process for accurate traceability of the test sequence with critical results
  • Removal of the last drop of the injection allows for clear recognition of the needle tip, thereby guaranteeing reliable test results

Properties of the zwickiLine

  • 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

Standard compliance

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
Testing assistant with autoinjector testing system

Testing assistant roboTest N

With the roboTest N serving as testing assistant, 30 autoinjectors can typically be automatically tested with one magazine filling.The smart robot supports laboratory personnel by feeding the autoinjectors into the testing system and in performing the test.Removal of the protective cap, gripping of the injector and actuation of the injection through compression are automatically carried out in the testing machine.After the test, the testing assistant removes the autoinjector from the fixture and discards it.

The testing assistant roboTest N can be easily adapted to changing test sequences with a high level of flexibility, without requiring programming knowledge.For all robotic testing systems, the autoEdition3 automation software is used for information input and control.

roboTest R as fully automated autoinjector testing system

Robotic testing system roboTest R

The robotic testing system roboTest R is designed for fully automatic continuous operation (24/7) and is therefore set for consistent test requirements.The system also tests all relevant functions such as injection time, injection amount, needle length, actuation force and needle shield force.In addition, the ejection process is documented through video (Video Capturing).The robotic testing system takes care of discarding the tested specimens, and sorts them according to good/bad criteria.

To ensure reliable and comparable test results, all quality-relevant measuring devices such as the scale, load cell, displacement measurement and sensors for needle length and injection duration are verified on a daily basis (Daily Check).

Throughput at the lab can be increased significantly by using multiple autoinjector testing systems.Customers can either use their own trays for injectors or they can use the magazines provided by ZwickRoell.If necessary, additional measuring systems or testing machines can be integrated in the fully automated sequence.

Traceable and reliable test results

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.

Technical data

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Downloads

Name Type Size Download
  • Product Information:Autoinjector testing system AllroundLine PDF 501 KB
  • Product Information:Autoinjector testing system zwickiLine PDF 1 MB
  • Product Information:Testing assistant roboTest N PDF 140 KB

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