Sterile Barrier & Seal Integrity Testing

STEMart offers state-of-the-art technology and facilities to provide multiple strength and integrity test for packages to help manufacturers optimize the packaging design and performance. In order to ensure that the medical packaging doesn’t lose its integrity during the processing or distribution, we provide strength tests including tensile testing and burst testing, as well as integrity tests including bubble emission and dye immersion, and the whole package integrity test.

Our Seal Integrity Tests:

• Visual Inspection

  Visually inspect if there is wrinkle, inhomogeneity or channel formation on the sealing seam of the empty packaging or in the presence of the packaged product.

• Peel Test

  Visually inspect the peeled seam to assess the homogeneity and defects or fraying of package.

• Tensile Test

  Tensile test is one of the most common methods to measure material strength. The general procedure involves the linear stretching of material to failure or achieving some critical value. Tensile test can be performed on most types of materials and gives information about yield strength, ultimate tensile strength, and other important properties.

• Burst Test

  The Burst Test is used to measure and quantify the strength of a medical device package seal by pressurizing a package until bursts. There are several burst types available for testing including dynamic/static burst, creep test, and creep to fail. These burst tests can be carried out using either unrestrained or restrained methods, as well as either on open or closed packages.



• Container Closure Integrity Test

Container Closure Integrity Test detects the presence of communication between the contents of the container and its outside environment to determine if there is a leak (or fluid path) between the contents of a container and its surrounding. It assesses both the unwanted release of contents in a container and the possibility of contamination by solids, liquids or gases.

• Whole Package Integrity Test

The Whole Package Integrity test is applied to evaluate the package integrity of a finished product package. This covers a whole package microbial testing and sterility testing on the full-packaged product to determine the immersion of the indicator organism. Materials tested include pouches, trays, syringes, IV bags, tubing sets, vials, and containers.

With extensive expertise in consulting, package validations encompassing package and sterilization configurations, material qualification, and package development, STEMart can provide a full-service experience, support manufacturers to meet the regulatory goals, and minimize the compliance risks. If you have any additional questions about Medical Device Seal Integrity Testing or would like to consult with the experts at STEMart, please feel free to contact us.