I-Tek Medical considers SBP one of our cornerstone capabilities. Achieving and maintaining sterility are two of the industry’s biggest challenges. Understanding package testing and validation is essential.
Maintaining sterility from the production line to the surgical suite is the objective and function of sterile packaging. The materials, design, and processes associated with sterile packaging are a major challenge for every medical device manufacturer, and the test methods and validation process must be understood in order to develop a proper validation test plan.
Integrity evaluation ensures continuous package sealing and identifies any failures in the continuous seal. The two most common test choices:
- Dye Migration
- Bubble Emission
Strength evaluation determines the amount of force required to open the package. Failures can also occur during the three main tests:
- Seal Peel