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Packaging & Seal Integrity

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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 to pallet-level transit testing, Eurofins Medical Device Testing network of laboratories' 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.

 

Choose Eurofins Medical Device Testing to help you:

  • Validate that shipping configurations will withstand the rigours of global transit
  • Assess your packaging design and material selections
  • Ensure the integrity of your product’s primary sterile barrier
  • Confirm your labels conform to UDI regulations and remain readable through your entire distribution channel
  • Establish your product’s shelf-life through accelerated and real-time ageing

Learn about our new, state-of-the-art Package Testing Facility

Packaging integrity testing refers to various methods and processes used to assess and ensure the integrity of packaging materials, such as containers, bottles, blister packs, pouches, and other types of packaging used for medical devices and pharmaceuticals. The goal of these tests is to verify that the packaging effectively maintains its contents' quality, safety, and sterility.

 

Packaging and Seal Integrity Testing
Sterile Barrier/Seal Integrity Testing
Dye Penetration Bacterial Immersion Vacuum Decay
High Voltage Leak Detection (HVLD) Oxygen Headspace  
Distribution Testing
Transit Testing Package Drop Testing Stacked Box Crush Testing
Label Durability Testing Sutherland Rub UDI Readability
Package Material Testing
Dart Drop Elmendorg Tear Testing Peel Testing
Shelf Life & Accelerated Aging Testing
 

Your Global Package Testing Partner

Eurofins Medical Device Testing’s state-of-the-art Package Testing Lab is GMP, ISTA certified and ISO 17025 accredited to help evaluate every aspect of your packaging and labeling configurations. Our experts help perform functional testing, material testing, and accelerated and/or real time aging studies of primary and secondary packaging configurations to ensure your product will survive the rigors of global transit. Watch this video to learn more about our complete capabilities.

Ensure Your Device Survives Global Transport

No matter how or where your device is shipped, it is important to ensure your product will survive the rigors of global transit. Our state-of-the-art laboratory testing very precisely simulates various standard and custom distribution cycles per ISO 11607 and ASTM D4169, for the environmental conditions your packaging will encounter during transit. As you finalize your packaging designs, and prepare to conduct your validation work, our team of engineers is ready to work with you to ensure your product gets to its destination in the same condition it leaves your facility. Watch our video to learn more.

Verify the Shelf Life of Your Device

Any medical device brought to market must have an expiration date, backed by shelf life testing. Eurofins Medical Device Testing’s shelf life and accelerated aging testing services ensure your device meets its intended use just as effectively after years of storage as the day it was manufactured. With more than 200,000 ft3 of storage space, and a wide range of environmental chambers for predefined and custom conditions, our state-of-the-art labs support all aspects of your aging studies. Watch our video to learn more.

Maintain Sterile Barrier Integrity with Eurofins

Sterile Barrier Integrity Testing is critical throughout the course of distribution and storage for all terminally sterilized medical devices. Let Eurofins Medical Device Testing determine the most appropriate testing method based on your device and/or packaging configurations to ensure device integrity per ISO 11607, ASTM F1929 or ASTM F2096. Watch the video to learn more.