Ensuring Your Medical Device Meets Sterilization Standards Throughout the Supply Chain

Smithers Pira, Lansing, MI

Ensuring that device packaging meets specifications.

Considering the complex science and research that goes into developing medical devices, it is important to take time to consider the detailed process and requirements in place for safely delivering the product to the consumer.

Medical device manufacturers have to ensure their device arrives safely in a consumer’s hands and can withstand the hazards presented during sterilization and in the distribution chain. Depending on the type of sterilization utilized (ETO, gamma E-beam, etc.) this includes using the right combination of materials and designs to ensure a complete, sterile product is received.

Requirements set forth by ISO 11607 require the manufacturer to ensure the product and packaging system work together to create a complete product, which performs efficiently, safely, and effectively in the hands of the consumer. ISO 11607-1 details the elemental attributes demanded of materials and packaging systems intended for terminally sterilized medical devices. ISO 11607-2 describes the validation requirements for forming, sealing, and assembly process.

Manufacturers can guarantee a safe delivery through medical device and packaging testing in an independent, certified laboratory. This process provides assurance that a packaging system is sealed properly, will remain sterile throughout the supply chain, and complies with regulations. (See Figure 1)

Testing Services

Testing laboratories are able to simulate the hazards of the distribution chain and employ various packaging integrity tests. Services include a wide range of tests used to evaluate the strength, structure, and chemical properties of bags, pouches, blisters, and rigid packs, as well as the materials used in the construction of the sterile barrier systems. And, with the rapid shift from traditional pack types to flexible options, manufacturers can rely on a series of tests specifically designed for flexible packaging materials.

Tests include, but are not limited to the following:

Visual Inspection Test Method (ASTM F1886): Flexible packaging materials are tested using this method to determine if any channels are contained within the seal area. This test can detect channels down to a width of 75 microns (0.0003 inches) with a 60 to 100 percent probability.

Dye Penetration Testing (ASTM F1929): This test is used to determine the integrity of the package seal. Dye including a surfactant is injected into the package and contacts each seal for a specific amount of time. Seal failure is identified when dye penetrates through the seal.

Package Seal Strength Testing (ASTM F88): To evaluate the strength area within either a sealed tray or pouch, 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.

Bubble Leak Test (ASTM F2096): This test is used to challenge the entire surface area of the packaging system, as opposed to only the sealed area. This method is able to detect gross leaks with a sensitivity down to 250 microns (0.010 inches). A sealed tray or pouch packaging system may be tested with this method.

An experienced distribution testing laboratory can provide invaluable insight into relevant regulations, like the ISO 11607-1 and -2. With a better understanding of the test requirements and materials used to package medical devices, manufacturers can guarantee they are delivering the best device possible.

This article was written by Tim Rice, Business Development Manager, Smithers Pira, Lansing, MI. For more information, Click Here .

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