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.
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