It is required for manufacturers of medical devices to obtain approval for the type of packaging that is used. In order to meet the requirements, the manufacturer has to guarantee that the product and the packaging work together to provide the highest standard of safety and efficiency. Part of meeting these requirements is utilizing a package leak detector to ensure the package is not compromised in any way.
The Reasons behind Medical Package Testing
The package testing is done in an effort to make sure that the seal of the package meets the integrity standards. This type of validation provides assurance that the package will properly seal, that it is free from any leaks and fully protected from invasion by outside particles and contaminants.
How the Integrity of a Package may be Compromised
The primary reason that some packages are unable to meet the outlined standards is because of the parameters of the package sealing process. If the equipment used for sealing isn’t tested and monitored, then the manufacturer should expect failures in packaging and even costly product recalls. Also, packages may lose their integrity during certain events that take place while the product is being processed or distributed. It is imperative to utilize a package leak detector and other forms of testing to ensure the integrity of the medical products throughout the storage and handling phases.
Having medical equipment packages that meet standards will ensure that everything is delivered in perfect condition. The use of package leak detector services can ensure that medical equipment arrives at its destination intact and without any type of contaminants or other issues present. These tests help to prevent recalls, products being sent back and other costly events that may otherwise occur.