Package integrity testing is important in determining the sterility and the shelf life of a medical device or product. Package integrity testing includes dye leak (ASTM F1929), vacuum leak (ASTM D3078, ASTM D4991) and bubble leak (ASTM F2096) testing. Visual inspection (ASTM F1886) is also used as well to confirm package integrity.
In order to maintain a packaged product’s sterility until it reaches the point of end use, package designs need to incorporate a microbial barrier. Medical device manufacturers are required to demonstrate that package integrity is not adversely affected throughout the rigors of distribution simulation, accelerated aging, real time aging and up to the point of the medical devices stated shelf life.
The efficacy of the sterile barrier packaging design must be evaluated after exposure to environmental and dynamic stresses along with the specific expiration date (s) that the finished package is expected to see in its lifecycle.
Environmental conditioning, accelerated aging and distribution simulation testing provide a controlled means to expose a package to the predicted environmental and dynamic stresses that the samples may encounter in the real world. Package strength testing and package integrity testing provide the means to evaluate the packaging after exposure.
As an industry leader in medical device packaging testing with over 30 years of experience, DDL specializes in package integrity testing. Our engineers are available to help medical device manufacturers better understand integrity testing, how it used in conjunction with strength testing and ultimately help provide validation for a package design.
Contact us for more information or to talk to an engineer.
