ISO 11607 – Ensuring your medical device packaging meets the requirements

For medical device manufacturers, the hazards presented during sterilization and the supply chain have to be carefully evaluated when designing the product or packaging system. Depending on the type of sterilization utilized (ETO, gamma E-beam, etc.) the materials and designs selected will need to be compatible to ensure a complete, sterile product is received to the end user.

To ensure the device and packaging system are able to arrive at the final destination able to perform as designed, a number of product functionality and sterile barrier tests are used to demonstrate the entire design is able to maintain functionality and integrity. 

Smithers Pira’s staff of packaging engineers is able to simulate the hazards of the supply chain and employ the various packaging integrity tests which demonstrate compliance to requirements set forth by ISO 11607-1 and -2 – Packaging for Terminally Sterilized Medical Devices. There are numerous individual tests and processes that must be reviewed under the ISO requirements. The tests fall under three main categories (Strength, Structure and Chemical).

  • If the packaging system is comprised of flexible materials, the visual inspection test method, ASTM F1886, can be used to determine if any channels are contained within the seal area.This test method is able to detect channels down to a width of 75 microns (0.0003 in) with a 60-100% probability.
  • To further challenge the sealed areas of the packaging system, and confirm the results of the visual inspection test, a dye penetration test ASTM F1929, may be used.This test method is able to detect and locate a leak equal to or greater than a channel formed by a 50 micron (0.0002 in) wire in package edge seals formed by a transparent material and a porous sheet material.
  • To challenge the entire surface area of the packaging system, as opposed to only the sealed area, a bubble leak test, ASTM F2096, is used.This test method is able to detect gross leaks with a sensitivity down to 250 microns (0.010 in).A sealed tray or pouch packaging system may be tested with this method.
  • To evaluate the strength of the sealed area within either a sealed tray or pouch ASTM F88 is used.This method measures the force required to separate a test strip of the material containing the seal.It also identifies the mode of specimen failure.

While this list covers several of the test methods, an exhaustive list can be found here. The tests provide a guide for the evaluation of bags, pouches, blisters and rigid blister packs and the materials used in the construction of these sterile barrier systems. The data generated from these test methods can be used to demonstrate conformance with ISO 11607 for use in regulatory submissions to the FDA or EU. Contact a Smithers Pira expert today to learn more and review your specific medical device packaging requirements.

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