What is Tensile Testing?

Peel testing, also known as seal strength testing, is a tensile test that measures the strength of seals within flexible barrier materials. This measurement can then be used to determine consistency within the seal, as well as evaluation of the opening force of the package system.

One-inch wide test specimens are cut from a sealed package and placed in a universal testing machine, also known as a tensile test machine. The specimen is pulled in tension and the force required to separate the specimen is registered by a force gauge and recorded.

Why Perform Peel and Tensile Testing?

  • Peel testing is used to measure and quantify the strength of medical device package sterile barrier systems, as well as other sealed flexible packages
  • The seal peel tensile test determines the yield strength of the seal at a specific place on the package, which can be helpful in setting the sealing parameters
  • Peel testing assures you that your medical device packaging is sterile and easy to open, and helps avoid costly recalls due to seal failures
  • Seal strength is not only relevant to opening force and package integrity, but to measuring the ability of the packaging process to produce consistent seals

Guidance Documents / Standards:

ISO 11607 – Packaging for Terminally Sterilized Medical Devices

ASTM F88 – Standard Test Method for Seal Strength of Flexible Barrier Materials

EN 868-5 – Packaging for Terminally Sterilized Medical Devices. Sealable pouches and reels of porous and plastic film construction. Requirements and test methods

STERIS provides Customers with a broad range of test equipment for your peel, seal and tensile packaging test requirements.

Contact our team of experts to find out more about our Global Contract Sterilization Services