Testing solutions for pharmaceutical companies
Short development cycles, global teams and increasing regulatory requirements increase the complexity of modern testing processes. ZwickRoell supports pharmaceutical companies in bringing products such as primary packaging and drug delivery devices to market faster, achieving reproducible test results worldwide, and reliably implementing GMP and pharmacopoeia requirements.
What successful drug delivery device projects need
Testing must not become a bottleneck for development, qualification and the start of production. |
Standardized methods and workflows must enable consistent results across all development and production sites. |
Traceable processes and reliable qualification support make it easier to meet regulatory requirements. |
From central test programs and scalable automation to predictive quality: Create the foundation for a scalable and networked test environment. |
Shorten project lead times
Bring products to market faster
Delays in development and qualification projects can have a significant impact on market launches and production planning.
With standardized and customizable testing solutions, we help you to efficiently integrate testing processes into existing development processes and to reliably meet project schedules.
Faster marketability – how we support you
- Proven standard solutions: Proven testing concepts enable a quick and predictable project start.
- Individual customization: Application-specific solutions for components such as plugs and springs, as well as for individual testing requirements that go beyond requirements of standards.
- Application consulting and pre-tests: Pre-testing performed by our application technology laboratories at ZwickRoell help to assess feasibility at an early stage and to reliably design the right testing solution before purchasing the system.
- Checklists and URS templates: Industry-specific checklists support needs-based consulting; user requirements specification (URS) templates accelerate the clear and efficient definition of requirements.
- Efficient testing procedures: Combined or automated test sequences on a single machine enable multiple tests to be performed on a single specimen. This saves specimen, reduces effort and speeds up the testing process.
- Standard interchangeable part sets: Predefined interchangeable part sets for new devices enable early additional qualification. This helps avoid subsequent requalification efforts, shorten project timelines, and reduce costs.
Support at every phase of your testing project
Tailored services support you from the requirements definition to the reliable operation of your testing system. Even before an FAT appointment, we use your samples to check whether the solution functions as intended. This allows us to support you in implementing GMP requirements as well as qualification, documentation and quality assurance processes efficiently and in a traceable way. You can find all services in the overview section.
Achieve reproducible test results worldwide
Creating global consistency
For global pharmaceutical companies, reproducible test results across development, qualification and production sites are crucial. Standardized systems, processes and test methods create the basis for robust decisions and a successful method transfer.
Global consistency – How we support you
- Standardized testing solutions: Standardized systems, test programs, and services enable reproducible results at all locations.
- Method transfer:Standardized methods and defined processes facilitate transfer between development, qualification, and production sites.
- Minimized operator influence: Automated test sequences and defined specimen handling ensure operator-independent, reproducible results.
- Joint FAT: Cross-site acceptance testing aligns requirements at an early stage and ensures consistent implementation across locations.
- Software and interfaces: testXpert, standardized interfaces, and digital services enable standardized processes and consistent data exchange.
- Global support: Local experts support implementation, qualification, and operation to ensure that consistent standards are sustainably implemented worldwide.
Reduce risks in the GMP environment
Greater security for regulated processes
GMP, FDA 21 CFR Part 11, data integrity, and audit readiness place high demands on pharmaceutical testing processes. With qualified testing systems, traceable data, industry-specific services and many years of pharmaceutical expertise, we already support 95% of the leading pharmaceutical companies in implementing regulatory requirements safely and efficiently.
How we support you
- Qualification service: In-house qualification team for DQ, IQ, and OQ, as well as support for PQ.
- Advanced traceability: Our software's audit trail, electronic signatures and data integrity features support the requirements of FDA 21 CFR Part 11 and EU GMP Annex 11.
- Protected mode: Separate user accounts and controlled permissions in the testXpert testing software reduce the possibilities for manipulation at the operating system level.
- Standards and pharmacopoeias: Transfer of requirements from USP, EP, JP and other global pharmacopoeias into standardized test methods for development, qualification and production.
- White paper for pharmaceutical audits: Detailed explanation of the implementation of FDA 21 CFR Part 11 and EU GMP Annex 11 in the testXpert testing software. Available upon request
- Daily Checks and Poka-Yoke: Regular system checks (Daily Checks) and interchangeable parts that are mistake-proof, with scanning functions (Poka Yoke), reduce operating errors and incorrect part combinations.
- Global pharmaceutical expertise: More than 50 years of industry experience and over 80 service technicians specially GMP-trained support regulated testing projects worldwide.
Building the test environment of tomorrow
Future-ready testing systems
New device generations, increasing testing volumes and global operations require scalable testing processes that remain consistent across locations. Centrally accessible test and machine data, flexible levels of automation, and upgradeable systems help ensure standardized processes, reduce operator influence, and enable the test environment to adapt to future requirements.
Future-proof testing solutions – How we support you
- Centralized test method and data management: Uniform test methods, test programs, and a common data foundation across all locations.
- Preventive maintenance: Machine data such as system condition, usage, and service information support the early detection of maintenance needs, increase system availability, and help reduce unplanned downtime.
- Predictive quality: Test data such as test results, curve profiles and trend information enable data-based evaluations, support process optimizations and form the basis for well-founded quality decisions throughout the entire product life cycle.
- Scalable automation: From sequential and parallel test solutions to fully automated robotic testing, tailored to throughput and test requirements.
- Flexible and retrofittable systems: Modular test arrangements, additional interchangeable parts, and retrofittable hardware and software enable adaptation to new devices and future requirements.
Learn more about "Automation for more efficiency in testing" in ONdrugDelivery
Proven expertise in a regulated environment
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 can be found here:
To reference project Ypsomed To technical articles in ONdrugDelivery
Do you want more expertise for your testing strategy?
Expand your knowledge of safe and efficient testing processes in the pharmaceutical industry. Our white papers, which can be downloaded free of charge, offer practical insights, technical background information and guidance for your testing projects.
Explore white papers for the medical & pharmaceutical industries now
Downloads
- Product information: zwickiLine Up to Fmax 5 kN PDF 820 KB
- Product information: zwickiLine in cleanrooms PDF 180 KB
- Product Information: Autoinjector Testing System – AllroundLine PDF 705 KB
- Product Information: Autoinjector testing system zwickiLine PDF 1 MB
- Product Information: Autoinjector Testing System – Torsion PDF 524 KB
- Product Information: Autoinjector Testing System – Rear-part PDF 3 MB
- Product Information: Automated Autoinjector Testing System PDF 636 KB
