Medical Devices Packaging Testing

In addition to validating the design and functionality of your medical device, there are a myriad of testing requirements needed to ensure your product reaches the end user intact. From primary seal testing through pallet-level transit testing, our state-of-the-art Package Testing Facility provides complete capabilities for evaluating every aspect of your package and labelling configurations, to ensure your product will survive the rigors of being transported around the world.

Our state-of-the-art package testing facility is equipped to perform functional testing, material testing and shelf-life testing of primary, secondary and shipping configurations. We also provide a wide range of physical property testing in order to characterise and assess alternate packaging materials.

Perhaps the most critical aspect of packaging for a terminally sterilised device is the barrier seal that maintains the sterility of the product. Eurofins companies can assess the sterile seal integrity of virtually any device and/or packaging configuration, whether that barrier is maintained at the plunger interface of a pre-filled syringe, a heat-sealed pouch, blister or a thermoformed tray with a Tyvek lid. We have the most appropriate technology and capabilities for your specific application, including:

• Bacterial Challenges Testing
• Dye Penetration or Dye Leak Testing
• Vacuum Decay
• High Voltage Leak Detection
• Helium Leak and Oxygen Headspace Analysis
• Burst and Bubble Testing
• Packaging and seals integrity