ISO 11608-5 Autoinjector Testing
Autoinjectors are highly automated drug delivery systems where therapeutic success depends directly on the reliable functioning of the entire system. The ISO 11608-5 standard defines the requirements and test methods for automated functions in needle-based injection systems (handheld autoinjectors) – but the standard alone does not guarantee product safety.
The crucial difference lies in how the testing is carried out.
ZwickRoell offers comprehensive testing solutions for autoinjector testing – from design verification and quality control in production to innovative development tests, such as without drug (rear part testing) or with virtual spring simulation.
Solutions that not only comply with standards but also specifically address the challenges in autoinjector testing: realistic patient-use scenarios, full coverage of all essential drug delivery outputs (EDDOs), reproducible dose accuracy, minimal operator influence, and audit-ready documentation according to FDA 21 CFR Part 11.
ISO 11608-5 Objective Checklist:Key considerations for autoinjector testing Testing autoinjectors without medication Testing with virtual springs FAQs Downloads Request a consultation
Objective & regulatory framework of ISO 11608-5
Autoinjectors are safety-critical drug delivery systems and their reliable performance is essential for therapeutic and patient safety. Accordingly, the their testing requirements are stringent: results must be reproducible, traceable, and independent of the operator.
ISO 11608-5 requires testing under real-world use conditions, replicating how patients actually use the autoinjector. In addition, the FDA requires proof of all essential drug delivery outputs (EDDOs), including actuation, injection time, dose accuracy, injection depth, and safety functions.
ZwickRoell combines these regulatory requirements with practical testing technology: realistic patient-use test procedures, objective measurement methods, and audit-ready documentation in accordance with FDA 21 CFR Part 11, including electronic records, user access controls, and an audit trail. This transforms regulatory requirements into reliable test results and sustainable competitive advantages – from design verification to automated serial testing.
Checklist: What really matters when testing autoinjectors
The following checklist shows the critical success factors of a standards-compliant and FDA-compliant autoinjector test – and how ZwickRoell systematically ensures these.
✅ Are all essential drug delivery outputs (EDDOs) fully covered?
✅ Is the autoinjector tested exactly as the patient uses it?
✅ Are test results independent of spray mist, droplet formation, and contamination?
✅ Is the "last drop" correctly recorded and documented?
✅ Is the volume measurement accurate and reproducible?
✅ Is operator influence minimized and operator error consistently eliminated?
✅ Are sensors and measuring systems backed up daily?
✅ Is the testing process documented in a way that is traceable for an FDA audit at all times?
✅ Is the solution future-proof and scalable?
The ZwickRoell autoinjector testing solution: One system for all regulatory-relevant outputs
The ZwickRoell approach: All relevant test parameters, from actuation, injection time, and dose accuracy to injection depth, safety functions, and optical and acoustic feedback, are recorded sequentially on a single specimen.
The decisive advantage:
No fragmentation across multiple test stands. All measurement results originate from a consistent test sequence and form a unified, audit-ready data foundation for each test item, with reduced operator influence and improved cost and time efficiency.
Scalable systems are available for different areas of application:
- zwickiLine 2.5 kN – compact, space-saving solution for R&D and design validation with a reduced, but standards-compliant testing scope. Learn more
- AllroundLine 5 kN – reference system for design verification, quality control, and production with maximum testing scope and high flexibility. Learn more
- roboTest N for fully automatic testing of up to 150 autoinjectors per run or roboTest R as a high-end solution for 24/7 operation.Learn more
This creates a comprehensive testing system that reliably delivers all regulatory-relevant outputs – from development through to automated series testing.
Videos featuring our testing solutions for autoinjector testing
Not an off-the-shelf testing solution, but one tailored to your autoinjector.
Our autoinjector testing systems form the modular basis for individual testing requirements in R&D, design verification, quality control, and series production testing. Together with you, we configure the solution that fits your device design, your testing process, and your regulatory requirements.
Discuss your custom testing solution
ZwickRoell solution: Realistic patient-use testing
ISO 11608-5 and FDA guidance require that autoinjectors be tested according to the instructions for use under realistic conditions, replicating the motions, forces, and sequences performed by the patient. What matters is not only the measurement result, but also the realistic simulation of actual use.
ZwickRoell consistently implements this requirement:
The injector caps can be pulled off sequentially both upward and downward without requiring any changes to the test fixture. This allows autoinjectors to be tested exactly as they are operated by the patient – regardless of the specific cap design or the prescribed pull-off direction. The force required to remove the cap is determined and documented in accordance with standards in both directions.
Since cap removal depends significantly on geometry and surface properties, rigid or limited gripper solutions are often insufficient in practice. The universal ZwickRoell cap gripper allows for individual adjustment of the holding forces and thus responds flexibly to all currently known injector cap designs. After testing, the cap is automatically ejected, eliminating the need for manual intervention and ensuring the testing process remains consistently realistic for patients.
ZwickRoell solution: Reliable test results – Regardless of spray mist and contamination
In autoinjector testing, drug spray mist, droplet formation, and sensor contamination present significant challenges. Many conventional measuring systems rely on contact-based sensing close to the sensor or single-image analysis, resulting in reduced accuracy and reproducibility under real testing conditions.
ZwickRoell addresses this practical challenge with camera-based measurement of injection time, injection depth, and injection process using the VDX camera system. The measurement is contactless and independent of the injection stream – the camera is deliberately positioned at a safe distance so that spray mist or droplet formation does not influence the measurement results.
The performance of VDX measurement is particularly evident in the measurement of injection depth: Here, fractions of a millimeter determine whether the medication is delivered to the intended tissue layer. The VDX system enables injection depth measurement for needle lengths from 2.5 to 15 mm with an accuracy of < 0.05 mm. At the same time, injection time measurement down to < 0.05 s enables reliable capture of even the fastest injection processes, including those of emergency injectors.
Another unique feature is the time-controlled, continuous video recording (video capturing):
Instead of individual images, the entire injection process is recorded in high resolution, time-synchronized, and without gaps. Live images, videos, and additional individual recordings can be directly linked to the measurement curves and saved for analysis, documentation, and audits.
ZwickRoell solution: Dose accuracy including the "last drop" – Complete and traceable
Following the precise recording of injection time and depth, the "last drop" plays a central role in dose accuracy. It is therapeutically relevant and part of the regulatory assessment of complete drug delivery.
The VDX camera system not only captures the injection process in terms of timing and geometry, but also documents the emergence of the liquid, the needle tip, and the detachment of the final drop. This image and video data is stored synchronously with the measured values and enables a clear, reproducible evaluation of successful injections.
Thanks to the flexible adjustment of the camera's field of view, the system can be precisely positioned right up to the needle tip. This enables even fine droplet formation, the injection angle, and the complete detachment of the last drop to be reliably recorded.
A key advantage is the integrated parameterization of the injection end, including the "last drop”. Combined with weight-based volume measurement, this results in a clear definition of the actual end of dose delivery – without estimations or room for interpretation.
The benefit: Vollständige Dosiergenauigkeit – objektiv gemessen, visuell dokumentiert und regulatorisch belastbar.
ZwickRoell solution: Reproducible volume measurement – Even under electrostatic charging
Precise determination of the injection amount is a key component of dose accuracy. In practice, however, weighing results are frequently distorted by electrostatic charges, especially with glass or plastic beakers.
ZwickRoell therefore relies on stainless-steel collection beakers with sealing caps to significantly reduce electrostatic effects and ensure stable, reproducible volume measurement. An optional ionization unit can be used to further minimize residual charges.
Additionally, the cap reduces the evaporation of the medication by up to 80%, ensuring that the measured volume remains constant throughout the measurement period.
ZwickRoell solution: Minimize operator influence – Systematically eliminate errors
To ensure reproducible and audit-ready test results, it is crucial that operator influence is consistently minimized and mistakes are prevented before testing even begins. ISO 11608-5 and FDA regulations require that test results be comparable regardless of the person, shift, or location.
Poka Yoke
ZwickRoell uses injector-specific interchangeable parts based on the media bath principle. Each autoinjector is tested using specifically designed holders, jaws, and gripping points. They are designed to prevent mix-ups and ensure a secure hold without slipping, without affecting the functionality of the injector. Since the internal mechanisms of autoinjectors vary significantly depending on the manufacturer, defined injector- specific gripping positions and adjustable clamping forces are crucial for realistic and reliable testing.
All interchangeable parts are uniquely assigned to a test set and matched to the injector-specific test program. In combination with an optional handheld scanner, the interchangeable parts are uniquely identified before the test begins. The test is released only after the correct setup has been verified. This reliably prevents program mix-ups, incorrect fixture setups, or swapped test specimens – especially in high-volume or multi-shift testing laboratories.
Camera-based injector identification - additional plausibility check
Additionally, camera-based injector identification enables further plausibility checks of the specimen. Using color, edge, and geometry recognition of autoinjector components, it can be verified whether:
- the correct injector type was used
- the injector is correctly aligned (not rotated or inserted upside down)
- the colored plunger has reached the end-of-dose position
The benefit:
Mistakes are prevented, not documented. The result is a highly reproducible, error-free testing process, independent of the operator.
ZwickRoell solution: Daily Checks – tested sensors before every test run
ZwickRoell optionally ensures the reliability of all autoinjector testing systems through systematic daily checks. These checks involve verifying the functionality and measurement accuracy of all relevant sensors – including those for force, weight, length/injection depth, acoustics, camera, and color recognition – on a daily basis.
These daily testing procedures are designed to be time- and cost-efficient and can be easily integrated into routine operations. A critical safety mechanism: If a sensor deviates from its target value, test initiation automatically prevented. This prevents inaccurate test results from the outset and minimizes the risk of incorrect approvals.
The benefit:
Maximum measurement reliability and system availability – day after day, across all sensors, and audit-ready.
ZwickRoell solution: Audit-ready documentation – FDA-compliant according to 21 CFR Part 11
Audit-ready autoinjector testing requires not only valid measurement results but also fully traceable, tamper-proof documentation. ZwickRoell relies on testXpert testing software with validated, injector-specific test programs for this purpose.
The test programs precisely tailored to the respective autoinjector and its associated interchangeable parts and are parameterized and validated by ZwickRoell. This ensures that the test setup, test procedure, and evaluation are reproducibly aligned and that all results can be clearly assigned. This systematic approach is crucial for internationally operating companies: Uniform machine settings, identical test procedures, and harmonized test programs ensure that results are comparable across locations – both between their own plants and with suppliers. Joint FATs (Factory Acceptance Tests at ZwickRoell before delivery) and global SOPs (Standard Operating Procedures) support consistent implementation across all sites worldwide.
The entire test execution and data analysis are performed using the testXpert testing software, which integrates seamlessly into the IT environment of pharmaceutical companies. With the Expanded Traceability option, the software complies with the requirements of FDA 21 CFR Part 11.
All test-relevant actions are automatically logged in the audit trail, stored in a tamper-proof manner, and made available for evaluation when required. User rights and electronic signatures ensure clear responsibilities and efficient, paperless documentation.
The benefit:
Audit-ready out of the box – robust from a regulatory perspective, easily adaptable, and fully traceable.
ZwickRoell qualification service DQ · IQ · OQ – Assurance Through Validated Testing Systems
ZwickRoell supports pharmaceutical companies not only throughout the testing process, but also in the qualification of autoinjector testing systems through the DQ, IQ, and OQ phases, providing comprehensive qualification documentation tailored to individual requirements, as well as during the actual on-site qualification procedure. The modular documentation is customized to the testing system's configuration by our in-house ZwickRoell qualification department.
More on qualification service Request a consultation
ZwickRoell solution: Future-proof testing solution with maximum investment security
No two autoinjectors are alike – the more individual the device design, the more flexible the testing technology must be. ZwickRoell autoinjector testing systems combine standardized, standards-compliant test methods with a modular design, making them ideally suited for manufacturers and CDMOs that are regularly confronted with new products, variants, and requirements.
A single testing machine covers a wide variety of injector types and can be expanded without tools to include new products such as syringes (PFS), needle safety devices (NSDs), or pens. At the same time, the solution can scale to higher throughput, up to and including fully automated specimen feeding.
The benefit:
A testing solution that grows with your requirements – with minimal investment risk.
Automated autoinjector testing according to ISO 11608-5
For increasing testing volumes and large production batches, ZwickRoell offers scalable automation solutions – from automated laboratory support to fully automated 24/7 testing.
Common features of all automated ZwickRoell solutions
- ISO 11608-5 compliant testing of all relevant functional parameters
- Automated specimen feeding and removal
- Video capturing of the injection process for additional documentation
- Automated specimen disposal including good/bad sorting
- Daily verification of all quality-relevant measuring equipment (Daily Checks)
- Use of ZwickRoell or customer-specific trays
roboTest N: automated autoinjector testing for simple applications
- Automated testing of up to 150 autoinjectors per run
- Ideal for changing testing tasks, with easy changeover to needle safety devices testing using dedicated conversion components and inserts
- Flexible adaptation to new testing procedures without programming knowledge
- Supports laboratory personnel with specimen feeding and handling
- Typical application: Design verification, quality control, small production runs
Learn more about roboTest N Request a free consultation
roboTest R: Fully automated 24/7 testing for series production
- Designed for continuous operation (24/7)
- Parallel connection of multiple testing machines for maximum throughput
- Expandable with additional measuring systems and test stations
- Complete process automation without operator intervention
- Typical application: Large production runs, high quantities, maximum productivity
Learn more about roboTest R Request a consultation
Discover your optimal testing solution for autoinjectors – we will provide comprehensive consultation!
Are you looking for precise, automated test procedures according to ISO 11608-5? Our experienced team will assist you in selecting suitable systems – whether semi- or fully automated. We will make your testing process efficient, reliable, and standards-compliant.
Autoinjector testing in development & production – Function testing without medication
In the early stages of development, and even during series production, device manufacturers often have little or no access to the final drug product. The final drug product is typically held by the pharmaceutical manufacturer or is only available in limited quantities. At the same time, drug-based testing would be complex, costly, and subject to additional regulatory requirements.
With the rear part tester, ZwickRoell offers a cost-effective alternative for testing the mechanical function of the injector before filling with the drug product, while still replicating a realistic ISO 11608-5 test procedure.
An electromechanical servo testing actuator simulates the counterforce of the drug cartridge that acts on the autoinjector mechanism in the actual system. The autoinjector is positioned in the testing machine, the test is started via the testXpert testing software, and then performed fully automatically.
The following data is recorded, among other things:
- Force or torque required to remove the safety cap
- Characteristics of the installed drive spring (spring rate)
Monitoring, evaluation, and documentation are performed entirely within testXpert – including audit-ready data acquisition in accordance with FDA 21 CFR Part 11. For higher throughput, the system can optionally be automated with the lightweight robot roboTest N.
Benefits:
Cost-effective, reproducible function testing without medication – ideal for development, pre-production and production-like testing when access to the active ingredient is limited.
Autoinjector development – Testing without physical springs using virtual spring simulation
In spring-driven autoinjectors, the spring characteristic has a significant impact on reliable actuation and complete drug delivery. Especially with highly viscous medications, after aging, or under varying temperature conditions, breakaway and glide forces must remain reliable. However, in development, using actual springs often involves significant effort, limited flexibility, and reduced comparability.
With virtual spring simulation, ZwickRoell offers an innovative testing method that completely eliminates the need for physical springs. Instead of using mechanical components, the testXpert testing software takes over the function of the spring: The desired spring characteristic (e.g., soft, stiff, progressive) is defined directly in the software, and the testing machine follows this force-controlled curve as a realistic force-displacement curve.
This allows the fast, reproducible simulation of a wide range of spring characteristics without mechanical modifications. In combination with an optional temperature chamber, temperature-dependent effects can also be realistically reproduced.
Advantages at a glance:
- No replacement or inventorying of physical springs
- Quick adjustment of the spring characteristic via software
- Reproducible, standards-compliant test conditions
- Reduced testing effort and higher development efficiency
- Ideal for development, comparative studies, and design verification
Benefits:
Maximum flexibility and meaningful results in development, with significantly reduced effort.
An autoinjector is a single-use injection system (NIS) designed to administer the entire drug volume in a single injection. It consists of:
- a prefilled syringe (PFS) with an injection needle
- a mechanical device, usually featuring a spring mechanism
The syringe and device are regulated components and together form a combination product. The spring mechanism replaces manual thumb pressure and, depending on the design, controls both needle insertion and drug delivery.
Currently, there are two different types of handheld autoinjectors on the market:
- Actuation via needle shield: Injection starts automatically upon reaching a defined contact force.
- Actuation via button: Injection is actively started via an actuation button.
Both systems must be tested exactly as they are used by the patient – a key requirement of ISO 11608-5.
Due to the specific application of body-worn autoinjectors , also known as wearables or on-body delivery systems (OBDS), different testing requirements apply than for handheld autoinjectors. For this reason, the separate standardISO 11608-6 was introduced, which specifies the requirements and test methods for needle-based injection systems for use on the body.
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The ISO 11608-5 standard defines, among other things, the following tests:
- Pull-off force of the safety cap (upward & downward) and tightening torque
- Activation force and travel
- Injection time
- Dose accuracy incl. the “last drop”
- Injection depth & needle shield after injection
- Safety functions of the needle shield
In addition, the FDA requires verification of the acoustic feedback signals provided to the user (ERPs).
Downloads
- Industry Brochure: medical industry PDF 6 MB
- Industry brochure: Testing Solutions for Injections Systems PDF 3 MB
- Product Information: Autoinjector testing system zwickiLine PDF 1 MB
- Product Information: AllroundLine autoinjector testing system PDF 705 KB
- Product Information: Compartment magazine for roboTest N automation PDF 636 KB
- Product Information: Daily Check for Autoinjector Testing Systems PDF 176 KB
- Product Information: Spring Simulation of Autoinjectors PDF 684 KB
- Product Information: Traceable and Reliable Test Results in Accordance with FDA 21 CFR Part 11 PDF 1 MB
- Product Information: Qualification of ZwickRoell Testing Systems PDF 1 MB
- Product Information: Autoinjector Rear Part Tester PDF 3 MB
