Testing of Injection Systems
The challenge for pharmaceutical companies and manufacturers of drug delivery devices lies in packaging a wide variety of drugs in different dosage strengths and viscosities into injection systems and administering them to the patient. The market offers many options, each with its own challenges. But which is the right one for you?
Modern injection systems – from syringes and pens to autoinjectors and on-body drug delivery systems (OBDS) , including their components such as needles, connectors, cartridges/pre-filled syringes, and needle safety devices (NSDs) – must function with high precision, safety, and user-friendliness. As biologics and other complex drugs become increasingly viscous, individualized, and administered more frequently in home-care settings, the demands on actuation force, injection time, dose accuracy, and reliability are rising significantly.
ZwickRoell offers a comprehensive, modular, and customizable testing portfolio that supports the entire development and manufacturing process as well as quality assurance. Our testing machines and solutions cover all relevant tests for various drug delivery systems – compliant with standards, reproducible, and optimally tailored to real-world operating conditions.
Testing solutions according to standard Testing solutions according to device Automated testing solutions Customer projects & references Request a consultation
Furthermore, we support the introduction of new injection systems from the URS (User Requirements Specification) through DQ, IQ, OQ, and PQ to audit-ready electronic documentation of test results in accordance with FDA 21 CFR Part 11 – for maximum data integrity and regulatory compliance. A key component of this process is our Factory Acceptance Test (FAT) , in which your system is fully tested, functionally verified, and aligned with the jointly defined URS scope before delivery.
FDA 21 CFR Part 11 DQ/IQ/OQ support
Standards and legal requirements for testing injection systems
The testing of drug delivery systems is subject to strict international standards and regulatory requirements – from ISO, DIN, and ASTM standards to FDA guidelines and the requirements of the United States Pharmacopeia (USP). These regulations define in detail how aspects such as mechanical durability, glide forces, dose accuracy, and user-friendliness are to be validated. International ZwickRoell medical and pharma-experts actively participate in the further development of these standards in relevant committees and support manufacturers worldwide in reliably interpreting regulatory requirements and implementing standards-compliant, future-proof testing solutions.
ZwickRoell testing solutions for injection systems
ZwickRoell offers a comprehensive portfolio of testing systems for all common injection and drug delivery devices. These systems enable of standards-compliant testing of key parameters according to relevant ISO, FDA, and USP specifications.
Optional automated testing solutions increase throughput, minimize operator influence, and ensure maximum reproducibility. This creates a flexible testing environment that reliably supports pharmaceutical companies and manufacturers throughout development, validation, and production.
Testing solutions according to standard
| Short description | Standards |
|---|---|
| Medical | NIS needle-based injection systems | Overview |
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| Medical | NIS | Dose accuracy & pen mechanics |
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| Medical | NIS cannulas | Needle-to-pen compatibility |
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| Medical | NIS cartridges | Breakaway/Glide force & Leak tightness |
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| Medical | NIS autoinjectors |
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| Medical industry | On-Body Delivery Systems (OBDS) |
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| Medical | Syringes | Prefilled syringes (PFS) |
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| Medical | Syringes | Single-use syringes | Breakaway/Glide force & Leakage |
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| Medical | Luer/Luer lock connection |
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| Medical | Cannulas & needles | Break resistance |
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Discover the optimal testing solution for your injection system – we will provide comprehensive consultation!
Our experienced team of experts will support you with all questions concerning standards-compliant testing methods, suitable testing systems, and customized solutions for your injection systems!
Request a non-binding consultation
Automated testing solutions for injection systems
Complex devices such as autoinjectors, insulin pens, or prefilled syringes require highly precise and reproducible testing. Manual processes quickly reach their limits – fluctuations, operator errors, and limited throughput affect both quality assurance and development. Automated testing solutions provide a remedy: They increase repeatability, reduce personnel influence, and significantly boost capacity.
ZwickRoell offers a wide range of automation levels – from semi-automatic systems for smaller production runs to serial and parallel testing stations, all the way to fully automated robotic systems for 24/7 operation. Typical solutions include, for example:
- X-Y table setups for the sequential plunger glide force and leakage testing on syringes (PFS), cartridges, and the testing of the residual seal force (RSF) on medicinal vials and cartridges
- Automated carousel systems for highly accurate determination of dose accuracy, breakaway force, and glide force on syringes
- Parallel setups for time-consuming tests to determine the breakaway and glide force on single-use syringes
- Robot-controlled complete systems including specimen handling, cap removal, injection simulation, video analysis, and integrated weight measurement of the injection fluid.
Serial and parallel testing systems for syringes, cartridges, and injection vials
Fully automated testing of injection systems
ZwickRoell offers high-performance, robot-assisted testing solutions for a wide range of modern drug delivery systems – from autoinjectors and pens to prefilled syringes (PFS) and needle safety devices (NSD). At the heart of this is the modular robotic testing system roboTest N, which enables highly precise, reproducible, and completely operator-independent testing procedures.
Further information on robot-assisted testing solutions can be found in the testing solutions section by device/component and standard.
Interesting customer projects and cooperations in the medical and pharma industry
Innovative therapy systems arise not only from precise testing technology, but also from collaborative partnerships throughout the entire product lifecycle. From initial consultation and individually configurable testing solutions to training, software updates, and predictive maintenance, ZwickRoell reliably supports more than 2,500 customers in the medical and pharmaceutical industries through all regulatory and technological developments. Close cooperation with industry partners drives the development of pioneering testing protocols and joint development projects, making a crucial contribution to safe, future-proof medical devices and modern healthcare.
Explore the following customer projects and discover how leading manufacturers and ZwickRoell are setting new standards together.
FDA 21 CFR Part 11 – Security and confidence in injection system testing
The medical and pharmaceutical industries are subject to particularly stringent requirements for the traceability, security, and integrity of test data. FDA regulation 21 CFR Part 11 governs the conditions under which electronic records and electronic signatures may replace paper-based documentation. The goal is to ensure that digital test data is trustworthy, tamper-proof, and traceable at all times —and thus legally equivalent to paper documents.
ZwickRoell supports you in complying with these requirements with testXpert III testing software and the traceability option. All test-relevant actions and changes are automatically logged in an audit trail, stored in a tamper-evident manner, and can be retrieved in a readable format when required. Electronic signatures provide clear accountability and enable efficient, paperless documentation. The scope and depth of logging can be flexibly tailored to your internal QA requirements.
In addition, ZwickRoell supports you with qualification services (DQ / IQ / OQ) for the validation of your testing systems. This creates the technical and organizational foundation for conducting compliant, efficient, and audit-proof testing of injection systems – in accordance with FDA 21 CFR Part 11 and the expectations of a regulated environment.
ZwickRoell qualification service DQ · IQ · OQ – Assurance Through Validated Testing Systems
In the regulated environment of the medical technology and pharmaceutical industries, the qualification of testing systems is a key component of quality assurance. Legal requirements and international guidelines such as GMP (Good Manufacturing Practice) and GAMP (Good Automated Manufacturing Practice) mandate that all test-relevant equipment and computerized systems are traceably documented, evaluated, and verified throughout their entire lifecycle. The goal is to minimize risks and ensure patient safety at all times.
With the ZwickRoell DQ/IQ/OQ qualification service, you receive structured, field-proven support for precisely this task. The process begins with a system-specific specification that supports you in preparing your URS (User Requirements Specification). Building on this, an RA (risk analysis) is conducted, in which all GMP and safety-relevant requirements are evaluated and consistently mapped throughout the entire qualification process.
ZwickRoell supports you from design qualification (DQ) through installation qualification (IQ) to operational qualification (OQ) – with modular, audit-proven documentation packages that can be flexibly adapted to your requirements. Experienced and specially trained ZwickRoell experts efficiently conduct the qualification on-site at your facility – for both new and existing testing systems. This creates a solid foundation for audits and ensures that your injection system tests are compliant, reproducible, and audit-proof.
Downloads
- Industry Brochure: medical industry PDF 6 MB
- Industry brochure: Testing Solutions for Injections Systems PDF 3 MB
- 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
