Packaging and Seal integrity 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 labeling configurations, to ensure your product will survive the rigors of being transported around the world.


Choose Eurofins Medical Device Testing to help you:

  • Ensure the integrity of your product’s primary sterile barrier
  • Assess your packaging design and material selections
  • Validate your shipping configurations will withstand the rigors of global transit
  • 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 aging


Sterile barrier/ seal integrity testing

  • Dye Penetration or Dye Leak testing
  • Bacterial challenges testing
  • Vacuum Decay
  • High Voltage Leak Detection (HVLD)
  • Helium leak and Oxygen Headspace
  • Bust and Bubble testing
     

Transit Testing

  • Loose Load & Vehicle Vibration
  • Manual Handling & Drop
  • Focused Drop Impact
  • Vertical Stacking & Crush
  • Low Pressure/Altitude
     

Package Material Testing

  • Tensile or Flexural Strength
  • Moisture or Gas Transmission
  • Tear & Puncture Resistance
  • Seal Strength and Burst Testing
  • Flammability
  • Chemical Identification & Purity
     

Labeling

  • Barcode Verification
  • Sutherland Rub
  • Ink Adhesion Using Tape 

Questions? Call us now

+31622477880