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Testing Solutions for CDMOs

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

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

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.

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

Looking to find the right testing approach with us?

 

Our experts will be happy to advise you without obligation!

 

Contact us

 

SHL Medical logo

Proven by leading manufacturers in the medical technology and pharmaceutical industries

Companies worldwide rely on ZwickRoell testing technology for testing injection systems, needles, and medical devices. Further information about our expertise in CDMOs can be found here:

To reference project Ypsomed To technical articles in ONdrugDelivery Testing injection systems

 

Learn more about the right testing solution for your challenge

Autoinjector zwickiLine 2.5 kN
Autoinjector testing system AllroundLine
OBDS zwickiLine 2.5 kN
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 for the flexible testing of autoinjectors, pens, syringes, and NSCs

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.

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 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

 

Global expertise – with an understanding of local needs

Berndt
Erik Berndt

Global 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

Ritchey
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.

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Wong
Connie Wong

Regional Industry Manager for Medical & Pharma – ZwickRoell Asia Pacific

As Regional Industry Manager with a focus on materials testing solutions for the medical and pharmaceutical industries, Connie is responsible for the Southeast Asia, Taiwan and South Korea region. She works closely with the local sales teams to develop sustainable and forward-looking growth strategies.

In her work, Connie places great emphasis on high-quality solutions and collaborative relationships built on trust. Whether interacting with colleagues or serving customers, she prioritizes transparent communication, reliability and long-term partnerships.
Driven by a passion for continuous improvement, she aims to support the industry with integrity, efficiency and professionalism, and to continuously advance testing processes.

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Verma
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.

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