Testing Solutions for CDMOs

For evolving requirements – from development to release

CDMOs must test diverse devices flexibly, reproducibly, and traceably – from early process challenges to quality assurance in production. At the same time, requirements often change at short notice, while time, resources, and testing expertise are limited.

Find the right testing system

Why we’re a leading partner for CDMOs

We know the processes

From development through aseptic filling and device assembly to final packaging, our testing concepts support development, production, and quality assurance.

Industry expertise in medical technology

With experience in regulated environments, global expert networks, and participation in ISO and ASTM committees, we support safe and audit-ready testing processes in accordance with GMP and FDA 21 CFR Part 11.

Service offerings from URS to FAT

An experienced qualification team for DQ/IQ/OQ, FAT, and SAT services, combined with global service availability, supports secure testing processes from planning to validation.

Testing solutions for a wide range of devices

ZwickRoell testing solutions for the standards-compliant reliable testing of autoinjectors, pen injectors, prefilled syringes (PFS), NSDs (prefilled syringes with needle shield) and wearable OBDS

Proven expertise in a regulated environment

ZwickRoell - More than 50 years experience with testing solutions in the medical and pharmaceutical industry — Years of experience with testing solutions in the medical and pharmaceutical industry

95% of the world's leading pharmaceutical companies rely on ZwickRoell technology — of the world's leading pharmaceutical companies rely on our testing technology

1500+ globally installed ZwickRoell testing systems for the testing of injection systems for safe and reproducible results in a regulated environment — globally installed testing systems for safe and reproducible results in regulated environments

80+ ZwickRoell service technicians specially trained for FAT, SAT, and qualification processes — service technicians specially trained for FAT, SAT, and qualification processes

Tailor-made ZwickRoell testing solutions for CDMO processes

Easy device changeover on a machine

Problem: Testing different specimens such as autoinjectors, prefilled syringes (PFS), or OBDS leads to increased validation effort, project delays, and risks in quality assurance.

ZwickRoell solution:A comprehensive selection of testing systems for diverse testing requirements and throughput. Modular and scalable systems offer the right solution for every task – with comparable, reproducible results.

Injector-specific interchangeable parts: Market-leading unique testing platform for autoinjector, syringe, and pen testing on one system
Parameterizable test sequences for mapping device-specific differences
Same sensors, measurement chains, and software base across all device types
Flexible device changeover on a single qualified test platform

ZwickRoell testing solution for CDMOs - Modular testing system with easy device changeover on a single machine

Keep costs under control – scalable & future-proof

Problem:High demands meet limited budgets: Single tests increase costs, while testing systems must remain flexible and future-proof.

ZwickRoell solution:Scalable testing systems grow with the system through targeted retrofitting, while automated testing processes reduce costs, resource consumption, and operator influence.

Flexible design for different devices and future requirements – less conversion effort, more investment security
Preliminary tests with customer specimens in our own application laboratory to develop and validate suitable testing methods
Complete OBDS testing using a single specimen – automated, efficient, and resource-saving
Upgradeability of hardware, software and functions for future device requirements

Scalable, future-proof testing solutions from ZwickRoell for CDMOs in injection system testing

Operational reliability – stability under time pressure

Problem: Machine downtime directly impacts projects, approvals and delivery dates, significantly increasing time pressure.

ZwickRoell solution: High system availability combined with fast service and hotline support minimizes downtime and ensures stable testing processes when every hour counts.

Robust system architecture designed for continuous operation
10-year spare parts guarantee and intelligent spare parts packages to prevent downtime
FAT/SAT (Factory Acceptance Test/Site Acceptance Test)
International service availability
Condition monitoring, remote support and predictive support prevent unplanned outages
User training via ZwickRoell Academy

Operational reliability and high system availability for ZwickRoell testing solutions for CDMOs

Reproducible testing – reliable results in a regulated environment

Problem: Errors in testing lead to delays and audit risks – especially with changing requirements and limited testing expertise.

ZwickRoell solution: Extensive experience with testing processes in accordance with GMP requirements guarantee safe and efficient procedures. Proven, traceable testing approaches ensure reliable results.

Coded interchangeable parts with Poka-Yoke function prevent incorrect operation
Vision sensor detects colors, edges, and geometries for the safe positioning of the injector
Automatic cap ejection eliminates manual operator intervention
Experienced qualification team for DQ/IQ/OQ and audit-ready test data according to FDA 21 CFR Part 11
testXpert testing software: Repeatable test conditions and trend analysis for early detection of deviations

Reliable testing solutions for CDMOs for reproducible testing – reliable results in regulated environments

Looking to find the right testing approach with us?

Our experts will be happy to advise you without obligation!

Testing expertise aligned with relevant standards

Our comprehensive expertise in ISO, USP, and device-specific requirements enables safe and reproducible testing for syringes, pens, autoinjectors, and wearables.

Testing solutions according to device type

Learn more about the right testing solution for your challenge

Autoinjector testing machine zwickiLine 2.5 kN for the flexible testing of autoinjectors, pens, syringes, and NSDs as a budget-conscious entry option

Autoinjector zwickiLine 2.5 kN

Ideal for development environments, start-ups, and applications with focused testing requirements and a budget-conscious entry point.

Space-saving testing platform for autoinjectors with needle shield actuation
Fast sequential test sequences with a single specimen per test
Device-specific test programs in testXpert testing software for quick setup and device changes
Injector-specific interchangeable parts for safe handling and reproducible results
Reliable weighing results thanks to a special collection cup to prevent antistatic influences

Autoinjector testing system AllroundLine

The reference system for all applications – from method development and device verification to method transfer in quality control.

Standards‑compliant cap removal testing upward and downward in accordance with the device’s instructions for use
Coded interchangeable parts with Poka-Yoke function to prevent incorrect operation
Vision sensor for reliable detection of position, colors, and geometries
Universal cap gripper for all common injector cap designs
Automatic cap ejection without manual intervention for efficient testing processes

OBDS zwickiLine 2.5 kN

The only system on the market for testing OBDS systems.

Precise testing even with long injection times and highly viscous medications
Complete recording of all relevant injection parameters including profile, time, and last drop
Various OBDS devices can be tested with only one specimen per test run
Prevents crystallization for accurate test results in biologics
Automatic detection of blink patterns to test the intuitive user guidance of the OBDS

Testing system with torsion

Additional torsion measurements are primarily required for locked autoinjectors or pens.

Activation of the autoinjector by rotational movement
Twisting off an autoinjector safety cap
Rotational movement for dose setting on pen injectors
Complete function testing of autoinjectors in an automated test sequence
Precise sensor technology and a sequential testing process minimize operator influences such as misaligned insertion or measurement errors
The testing machine, in combination with the testXpert testing software, ensures complete traceability of the test results

Autoinjector testing system for the flexible testing of autoinjectors, pens, syringes, NSCs, or OBDS

automated testing system

An automated testing system is always used when there is a very high volume of tests or when test results need to be particularly accurate.

Test results are highly reproducible due to the elimination of operator influence.
Manual Daily Checks guarantee reliable test results.
Even small production runs can be automated quickly and easily. Laboratories benefit from more accurate and faster test results.
Qualified laboratory personnel are relieved of routine activities, allowing them to focus on more complex tasks.
The lightweight robot is fully integrated into the ZwickRoell software environment, eliminating the need for robot programming knowledge.

Global expertise – with an understanding of local needs

Erik Berndt

Industry Manager Medical & Pharma - ZwickRoell GmbH & Co. KG

With over 17 years of experience at ZwickRoell, Erik Berndt is one of the leading experts in testing solutions in the medical and pharmaceutical industry with in-depth knowledge of international standardization, regulations and data integrity requirements.
As a member of several international ISO and DIN committees such as the Technical Committee “ISO/TC 84 - Devices for administration of medicinal products and catheters,” he actively contributes to the further development of standards for drug delivery devices. In numerous lectures and webinars, he provides expertise on industry-specific challenges, test methods and test solutions.

Contact us

James Ritchey

Regional Industry Manager for Medical & Pharma – ZwickRoell North America

As Industry Manager for Medical & Pharma, James has many years of experience in the mechanical testing of medical devices and pharmaceutical products, as well as in the development of standards-compliant testing strategies.

His area of expertise focuses on testing complex drug delivery systems, including autoinjectors and catheters, in accordance with relevant standards and regulatory requirements. Through his close collaboration with manufacturers and his involvement in international standardization bodies, James contributes in-depth expertise to ensure reproducible and efficient testing processes.

In addition, he shares his expertise as the author of specialist articles in industry-specific publications and serves as a board member of the ASM Materials Education Foundation.

Ashish Verma

Regional Industry Manager for Medical & Pharma - ZwickRoell India

Ashish has over ten years of experience in testing medical products and components. His technical focus is on providing application-oriented consulting and developing customized testing solutions for clients in the medical and pharmaceutical industries in India. Thanks to his in-depth application expertise, Ashish supports companies in implementing standards-compliant and efficient testing strategies – from selecting suitable test methods to practically implementing complex test requirements.

In addition, Ashish is a member of the BIS Committee MHD12 (Bureau of Indian Standards) and is actively involved in national standardization efforts for medical devices.

Matthew Reynolds

Medical Specialist - ZwickRoell United Kingdom

As Medical Specialist, Matthew supports manufacturers across the UK in the selection and implementation of mechanical and materials testing solutions for research, product development, and quality assurance applications. Combining an electrical engineering background with more than a decade of experience in technical sales, field service, and customer training, he helps organisations develop standards-compliant testing strategies for medical devices and pharmaceutical products.

His expertise includes testing solutions for drug delivery devices, medical implants, and other regulated healthcare products. Drawing on extensive engineering knowledge and hands-on experience within the medical technology sector, Matt advises customers from product development and validation through to production quality control, ensuring reliable and efficient testing processes.

Downloads

Product Information: Autoinjector Testing System – AllroundLine PDF 705 KB
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Product Information: Autoinjector testing system zwickiLine PDF 1 MB
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Product Information: Autoinjector Testing System – Torsion PDF 524 KB
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Product Information: Autoinjector Testing System – Rear-part PDF 3 MB
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Product Information: Automated Autoinjector Testing System PDF 636 KB
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