Summary of the Packaging Integrity Test
Packaging integrity testing is used to detect problems that may adversely affect the sterility of medical devices. It is very important for determining the sterility and the shelf life of medical devices. The test is designed to simulate the extreme conditions that products may encounter during transportation or storage. In ANSI/AAMI, "Packaging of Terminally Sterilized Medical Devices" is defined as "the unimpaired physical condition of the final package." In order to completely maintain the sterile state of the packaged product before use, the packaging design is required to incorporate a microbial barrier. For medical device manufacturers, they need to prove that packaging integrity will not be adversely affected throughout the rigors of distribution simulation, accelerated aging, real time aging, and until the stated shelf life of the medical device.
The Packaging Integrity Test Service Provided by Creative BioMart Microbe
As an experienced industry leader in medical device packaging testing, Creative BioMart Microbe provides customers with high-quality and cost-effective packaging integrity testing. Our engineers will help medical device manufacturers to better perform integrity testing of their products and verify package designs in accordance with ASTM standards. Our tests include:
Dye penetration test: It can be used to test whether the sterilized medical device packaging and other packaging have seal leakage.
Peel strength test: Evaluate the seal failure modes of the product package to ensure that the package can provide and maintain a sterile barrier for the product.
Bubble emission test: Bubble emission test for large leaks in flexible packaging under vacuum.
Accelerated aging: This test stores samples at elevated temperatures to simulate real-time aging in a shorter period.
Visual inspection is also used to confirm package integrity.
At present, Creative BioMart Microbe is developing other new methods in chemistry and microbiology, and these new methods can increase the confidence of manufacturers and end-users in the sterile packages of products.
Creative BioMart Microbe is a professional biotechnology company that has accumulated nearly two decades of experience in industrial microbiology. At present, we have built a powerful technology platform and recruited many researchers and engineers, aiming to provide customers from all over the world with high-quality, high-precision, and time-saving services. Our expertise makes us confident to be your trusted assistant in your project.
If you want to know more about this service, please feel free to contact us by phone or email, or you can consult through our inquiry form. We will ensure to provide you with efficient and high-quality experimental outsourcing services.
