Medical device manufacturers are called upon to obtain approval on each individual medical device package. According to the ISO 11607 standard, the manufacturer must ensure the product and package system conjoin to create a complete product which performs efficiently, safely, and effectively in the hands of the user.
Package Validation Testing is vital to ensure integrity of the package's seal. Validation will provide assurance and security that a package is sealed properly, leak-free, and secure from any number of outside contaminants. Accelerated aging should take place after the integrity of the product and package has been determined.
The main culprit for feeble package strength is the seal-sealing parameters. If a formal validation of the sealer is not carried out, the medical device manufacturer can expect failure. Packages may also lose their integrity as a result of the various events that occur during processing and /or distribution. Package Validation Testing may be used to validate that the package integrity has been maintained throughout the package's processing, expected shelf life, and handling.