Medical device manufacturers are required to obtain approvals for each type of medical device packaging. In order to meet Australian standards, the manufacturer must guarantee that both the product and the packaging together perform to the highest standards of efficiency and safety when presented to the end user.
Why Is Medical Package Testing Performed?
Medical package testing is done in order to ensure that the package’s seal meets integrity standards. Validation offers the assurance and secure knowledge that the package is properly seals, free of leaks and protected from outside contaminants. Accelerated aging should be done after package testing has been done.
How Package Integrity Can Be Compromised
The main reason that some packages fail to meet standards is the result of the parameters for the package sealing process. If the sealing equipment is not monitored and tested, the medical device manufacturer can expect packaging failures and product recalls. In addition, packages can also lose their integrity during events that may occur during the processing or distribution of the product. Medical package testing should be conducted in order to guarantee the integrity of medical products and their ability to deliver expected shelf life during handling and storage.
How Is Medical Package Testing Performed?
Medical packages may undergo a variety of tests to check package integrity that include:
● Visual inspection test
● Peel strength test
● Burst test
● Dye penetration test
● Creep test
● Bubble emission test
● Packaging leak detection of medical materials or devices
What Happens When Medical Packages Fail?
When packaging fails to meet Australian standards in the medical device industry, the repercussions can be much more severe than simply product loss and reduced sales. Medical devices are held to strict standards as sterility is an important concern for the industry, packaging that does not maintain sterility may cause severe illness and even death in patients. The results can be devastating to a company as much as to the patient and their family and may include lawsuits as well as, regulatory action.
Brand Trust Depends on Package Integrity
The reputation of a medical brand may also depend on the quality of the packaging. Failures in package integrity can quickly lead to safety concerns that will result in a loss of trust from its customers.
Sealtick offline standalone medical package leak testers help medical device manufacturers prevent faulty products and improve their existing QA/QC process. To learn more about the products that SealTick offers, contact us on 03 9540 5100.
