Terminally sterilized medical devices are contained in a package, which forms a barrier to microbial contamination as well as providing physical protection to the device during sterilization, shipping, handling and storage. In order to evaluate the efficacy of the package/product combination, physical testing is conducted.

This testing simulates the various stresses involved with sterilization, shipping and storage. These tests are designed to provide a reasonable degree of assurance as to how the package/product combination will perform in real life. Sterilization, shipping, handling and storage are dynamic events, which may have a detrimental effect on the medical device or its packaging components. The ability of the package to provide a microbial barrier might be compromised during any of these events.

Package Integrity and Package Strength testing are used to determine the overall integrity of the sterile barrier after exposure to a series of predetermined dynamic events.

Package Microbial Barrier Challenge tests may also be conducted on sterile packages to evaluate the ability of the package material to maintain the sterility of the product.

— Dye Penetration Test: ASTM F1929; Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.

Application: This method will determine leaks in both porous and nonporous packages. It is used to detect small leaks in materials or seals of packages where harmful biological or particulate contamination may enter. The method may be used to detect holes in package materials, or channels in seals, as small as .0025 inches. This test provides data on the integrity of the primary package directly after production and/or after experiencing a dynamic or environmental related event.

— Bubble Emission Leak Test: Flexible Packaging Association, FPA SPMC 005-96; Standard Test Method for Detection of Heat Seal Package Internal Pressurization, or ASTM D3078; Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission.

Application: This method will determine leaks in both porous and nonporous packages. It is used to detect leakage of air through packaging materials or the seal(s) of the package.

— Peel Test: ASTM F88; Standard Test Method for Seal Strength of Flexible Barrier Materials.

Application: This method will determine the strength of a specific area of the seal for a heat sealed package. It may be used on a pouch or tray/lid type package having two components joined by an adhesive or heat seal process. This method does not measure seal continuity. The most common applications are for establishing process control parameters, package performance specifications and package validation.

— Burst Test: ASTM F1140; Standard Test Method for Failure Resistance of Unrestrained and Non Rigid Packages for Medical Applications.

Application: This method is used to determine a package’s ability to resist internal pressure and measures the strength of the package's seals. The most common applications are for establishing process control parameters, package performance specifications and package validation.

— Visual Inspection Test: ASTM F1886; Determining Integrity of Seals for Medical Packaging by Visual Inspection.

Application: This method will determine channels as small as 0.003" width in the package seal with a 60% -100% probability. This test method is applicable to flexible and rigid packages with at least one transparent side, so that the seal area may be clearly viewed.