Medical products packaging testing are necessary for manufacturers of medical devices who must get 510 (k) approvals on each of their medical product packages. It is important that they get their medical product packages tested to ensure that these are compliant with ISO standards. It is up to the manufacturer of medical products to evaluate their packages to see that these packages are able to provide total protection to the products contained within.
From handling to distribution to storage, these packages should be strong enough to withstand all the normal events that are product package design company closely associated with distributing the product without any causing defects or loss of any sterility. The product must remain in its proper orientation so that it is safe to remove and then be used by the customer.
Proper medical products packaging testing must simulate all the normal events that are closely associated with distributing the product. After testing, the packages should have been passed fit for further safe distribution. Once the testing has been done and the package passed the test process, they will be certified as compliant to various industry standards including ASTM Standards and of course ISO Standards.
There are several tests that have to be performed including testing the package for integrity and for strength. The testing must be able to show the integrity of the packaging. It must show that the product in the package will remain sterile until it has reached its end point of use and the package must also have microbial barriers in the post sterilization environment.
It is up to the manufacturer to show that even during rigorous distribution and storage as well as handling and even aging that the package maintains its integrity for the shelf life of the medical product or device. The other testing that has to be done is one which helps to prove that the package is strong enough even when force is applied to separate 2 components (flexible) of a pouch or flexible lid.