Package Validation

Package Validation

In FDA, Packaging & Stability by Leslie Catalano

Medical device manufacturers have a responsibility to evaluate the packaging of a medical product and its ability to withstand the general occurrences associated with product distribution.

Throughout the past decade, there has been a noticeable focus increase by the Food and Drug Administration (FDA) on medical device package testing to help protect patients. Failure to maintain proper packaging can result in a loss of product sterility as well as high costs for the manufacturer.

Package Validation is the process of determining whether or not a package is able to maintain product sterility from the time the package is sterilized until the labeled expiration date. More specifically, the testing performed on product packaging needs to verify seal strength, whether or not the material can maintain a sterile environment, if it can withstand the transportation process and how long the it can preserve product sterility.

NAMSA can perform the entire package testing program in-house to expedite the validation services requested by our clients. Our testing includes transportation simulation programs for ASTM D4169 cycle 13 or ISTA, which can be conducted in-house at our Irvine, California location.  We also perform package testing such as ASTM F1886 Visual Inspection, ASTM F88 seal peel testing, ASTM F1140 Burst Testing, ASTM D3078 Vacuum Leak Testing, ASTM F2096 Gross Leak Test, ASTM F1929 Dye Penetration Testing and ISO/TAPPI Gurley Porosity Testing.

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