Medizinischer Pen mit Nadel in behandschuhter Hand, eingeblendeter Hinweis auf ISO 11608

Fine-Tuned Instead of Roughly Approved: PEN Injector Testing Where Every Detail Matters

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Precision Is Non-Negotiable

Pen and autoinjectors are precision systems people rely on every day—without compromise. ISO 11608 defines clear requirements, yet development reality quickly shows that standards set the framework, not the full picture. A needle-based injection system is not a single component, but a finely tuned interaction of mechanics, materials, drug properties, and user application. This is exactly where our testing approach comes in—going far beyond simply ticking compliance boxes.

System Understanding Instead of Isolated Values

Dose accuracy does not exist in isolation. Forces, friction, tolerances, and drug characteristics such as viscosity or temperature all influence overall system behavior. That is why our PEN testing always looks at the complete system.

The same applies to penetration and actuation forces. As human skin cannot be realistically simulated, we use standardized test scenarios to ensure comparability. The decisive added value, however, lies in expert interpretation. Our specialists translate raw data into reliable insights that directly support development decisions and regulatory submissions.

Testing Makes Development Predictable

Using advanced test setups, we capture multiple parameters within a single test run. Force–time curves provide deep insights into system behavior and reveal correlations that would otherwise remain hidden.

The result: early risk identification, fewer development iterations, and more predictable timelines. This approach is particularly effective when testing is integrated early in the development process - ensuring safety is not just verified at the end, but accompanies the product from the very beginning.

Ready for What Comes Next

Emerging applications such as intravitreal injections or smart injectors with digital connectivity increasingly challenge existing test methods. In many cases, clear standards are still missing. This is where our expert know-how makes the difference.

We continuously evolve and rethink test concepts, creating reliable foundations even where standards have not yet caught up. In this way, testing becomes a true value driver—and a dependable companion on the path to regulatory approval.

More about our Testing & Analytics capabilities