Safety and precision are of paramount importance when it comes to needle-based injection systems. Whether it’s a prefilled syringe or a novel delivery device, failure in mechanical performance, sterility, or patient usability can compromise patient outcomes and delay market access. But knowledge of the testing requirements or how exactly to schedule testing itself can be big stumbling blocks early on in the process.

Eurofins BioPharma Product Testing network of laboratories provides comprehensive syringe testing to help you verify performance, achieve compliance, and meet regulatory approval timelines. From break-loose and glide force testing to sterility and human factors studies, we can ensure your device meets the functional, mechanical, and usability standards demanded by regulators worldwide.

We work with companies at all stages – from early development through to batch release – delivering ISO and GMP-compliant testing that validates each component of syringe performance. The tests we perform are outlined in the applicable ANSI, AAMI, ASTM and ISO standards for the following areas:

• Mechanical Testing (ISO 11608): break-loose, glide force, Luer fitting, syringe-to-hub retention, syringe accuracy (TOGC)
• Biocompatibility and Chemical Characterisation
• Sterility and Residual EtO Testing
• Package and Sterile Seal Integrity Testing
• Accelerated Aging and Stability Studies
• Distribution & Transport Testing
• Siliconisation Testing
• Human Factors and Usability Testing

We tailor testing strategies based on your device’s design and intended use. Whether your syringe is a standalone delivery system or part of a combination product, our scientists and engineers will collaborate with you to identify required tests, write GMP-compliant and ISO standard-driven protocols, and execute validated methods.

The array of instrumentation in use across our global laboratory network includes:

• Instron® and Zwick systems for precision mechanical testing
• 500+ chromatographic analysers for extractables and leachables
• 12,200 m³ of environmental chamber space for stability testing
• 6,300 m² of microbiology lab space for sterility, endotoxins, and bioburden testing

We understand the pressure of product launches, partnering with you to plan testing timelines, optimise sample use, and manage regulatory documentation for submissions and approvals.

Whether you’re addressing mechanical performance or looking to integrate usability insights into your validation strategy, Eurofins BioPharma Product Testing can be your expert partner for syringe testing in supporting safe, efficient, and successful medical device commercialisation.