Package Integrity Testing
In order to maintain the sterility of a packaged product until it reaches its point of end use, the package must have a microbial barrier in its post-sterilization environment. The manufacturer must demonstrate that, under the rigors of distribution, storage, handling, and aging, the sterile package integrity is maintained at least for the claimed shelf life of the medical device or product.
The microbial barrier properties of the package materials and design must be evaluated after exposure to the environmental and dynamic stresses expected for the finished package. Several methods may be used to satisfy these requirements. They involve evaluating the material performance itself and the whole, finished package as produced on the packaging line. Packages may lose their integrity as a result of the dynamic related events which occur during processing and/or distribution. Physical test methods may be used to validate that the package integrity has been maintained throughout the package’s processing, expected shelf life, and handling. |
 Liquid Testing |
For more information on package integrity testing, see Leak Testing.
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