Our ISTA and ISO 17025-certified package testing laboratory provides medical device package validation testing according to ISO 11607, the principle guidance for validating terminally sterilized medical device packaging. We can help with the interpretation of the complex ISO regulations and advise you on how to execute your packaging validation projects on time and on budget.

ISO 11607 requires medical device manufacturers to demonstrate the efficacy of their proposed sterile barrier packaging. Environmental conditioning, accelerated aging and distribution simulation provide a controlled means to expose a packaging system to the anticipated environmental and dynamic stresses that the packaging system may encounter. Package strength testing and package integrity testing provide the means to evaluate the packaging after such exposure.

We provide standard testing for a wide range of sterile barrier medical packaging:

  • Visual Inspection: ASTM F1886, Determining Integrity of Seals for Flexible Packaging by Visual Inspection
  • Internal Pressurization: ASTM F2096, Detecting Gross Leaks in Packaging by Internal Pressurization (bubble test)
  • Vacuum Leak: ASTM D3078, Determination of Leaks in Flexible Packaging by Bubble Emission
  • Integrity/Dye Penetration: ASTM F1929, Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
  • Integrity/Dye Penetration: ASTM F3039, Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration
  • Seal Strength: ASTM F88, Seal Strength of Flexible Barrier Materials
  • Seal Strength: ASTM F1140, Internal Pressurization Failure Resistance of Unrestrained Packages (for medical application)
  • Seal Strength: ASTM F2054, Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates
  • Tensile Properties: ASTM D882, Tensile Properties of Thin Plastic Sheeting
  • Tear Resistance: ASTM D1922, Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method
  • Puncture: ASTM D3420, Pendulum Impact Resistance of Plastic Film
  • Puncture: ASTM F1306, Slow Rate Penetration Resistance of Flexible Barrier Films and Laminates
  • Puncture: ASTM D1709, Impact Resistance of Plastic Film by the Free-Falling Dart Method
  • Performance: ASTM D4169, Performance Testing of Shipping Containers and Systems
  • Performance: ISTA Series 1, 2 and 3 Distribution Tests
  • Aging: ASTM F1980, Accelerated Aging of Sterile Barrier Systems for Medical Devices

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