It is necessary that packages used for various medical devices meet certain standards. The most important factor that must be met when it comes to medical device packaging is sterility, which has to be maintained and ensured during the storage and distribution process. This ensures the product can be used efficiently and safely down the road. As a result, there are stringent medical device package testing procedures that must be used to ensure medical device manufacturers are in compliance with the packaging requirements.
Distribution Simulation
This medical device package testing process focuses on the effectiveness of the packaging used to withstand the most common shipping and distribution hazards. In addition to the normal wear and tear that occurs during the shipping process, the integrity of the package has to be maintained during any type of accident that may occur including boxes dropped by forklifts. In addition to being dropped, packaging must also stand up to low pressure, stacking tests, vibration tests and atmospheric conditioning tests.
Stability Testing
Various medical packages also have to be tested for stability to make sure that the products remain effective, sterile and safe for at least the length of the posted shelf life. To determine this, real time medical device package testing is used. However, because of the fact that medical technology evolves so quickly, there are some product distributors that utilize accelerated aging tests. This is something a manufacturer has to get approval for in order to utilize the results that are gathered.
There is no question that medical device package testing is a crucial part of distributing medical supplies. Keeping the information here in mind will help manufacturers understand what requirements must be met in order to avoid costly recalls on their products. The testing ensures integrity of the product from beginning to end.
