Sterile Barrier Packaging

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.

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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.

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Integrity evaluation ensures continuous package sealing and identifies any failures in the continuous seal. The two most common test choices:

• Dye Migration

• Bubble Emission

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Strength evaluation determines the amount of force required to open the package. Failures can also occur during the three main tests:

• Seal Peel

• Burst

• Creep