Sterile Package Integrity Testing
Medical packaging is highly regulated. Often medical devices and products are sterilized in the package. The sterility must be maintained throughout distribution to allow immediate use by physicians. A series of special packaging tests is used to measure the ability of the package to maintain sterility.
Loss of sterile barrier system integrity may occur as a result of the physical properties of the materials and adhesive or cohesive bonds degrading over time. Further loss may occur by subsequent dynamic events during shipping and handling. If you are developing medical device packaging per ISO 11607, the FDA wants you to develop a test plan for medical device packaging and state an expiration date on the label. You must prove that the integrity of the packed device remains intact throughout the shelf life of the product.
By following the guide line of ISO 11607 for packaging validation and assuring product sterilization, Test-O-Pac can help you conduct quantitative peel and burst testing as well as qualitative bubble and dye penetration followed by accelerated aging and distribution testing.
Gross Leak "Bubble" Testing |
Dye Penetration Testing |
Tensile Strength |
Burst Testing |
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