Quality packaging systems for sterile medical devices are essential for ensuring that the global healthcare marketplace receives safe and efficacious products. Contaminated products cannot be used, so it is imperative that the systems designed to protect them are adequate to the task. Many national and international standards have been developed to address packaging sterilization and validation of sterilization process for both industry and hospitals.

Packaging validation is a total process involving the identification and control of materials and processing variables that affect the ability of a packaged device to meet its acceptance requirements. The result of validation produces several benefits. One of the benefits were financial benefits that can be realized through reduced inspection, increased output, fewer complaints, and minimized scrap and rework.

Packaging validation must address three basic elements: requirements, assumptions, and capability assessments. It examines variations within a package, from package to package. It also examines the interactions within the handling and use system, which encompasses the manufacturing system, human interaction with the package, and the distribution and storage system and environment.

There are three approaches to validation: prospective, concurrent, and retrospective. Prospective validation is performed before the packaged device is commercially distributed. Concurrent validation is also performed before the device is commercially distributed. Retrospective validation is performed after the packaged device has been commercially distributed, it is based on the review of data collected and maintained during production.