We provide complete package integrity testing services in accordance with regulatory guidances. For medical device manufacturers complying with ISO 11607, package integrity is synonymous with sterile barrier system integrity test methods. For drug product manufacturers, the package integrity of sterile products concerns the ability of the container and closure system to keep product contents in while keeping environmental contaminants out. In this case, the product contents include the pharmaceutical formulation as well as the package headspace, which may consist of ambient air or nonreactive gases with a specified water-vapor content, under full or sub-atmospheric pressure levels.
Sterile, parenteral package integrity is often referred to as container closure integrity, while medical device manufactures refer to test methods for sterile barrier maintenance as package integrity testing.
Our testing programs include:
Container Closure Integrity Testing
Our container integrity testing laboratory offers numerous state-of-the-art options for leak testing and assessing pharmaceutical package integrity per USP <1207>. We apply container closure integrity test programs to optimize sealing parameters, evaluate container storage temperature impact, replace sterility tests for product stability batches, screen production lots for faulty packages and support regulatory submission applications for product commercialization around the world.
ISO 11607 Package Integrity Testing
To maintain a packaged medical device product’s sterility until it reaches the point of end use, package designs must incorporate a sterile barrier. Medical device manufacturers are required by regulatory agencies to follow ISO 11607 and demonstrate that the integrity of the sterile barrier is not adversely affected by distribution, storage and handling throughout the expected shelf life of the medical device. The efficacy of the sterile barrier packaging materials and design must be evaluated after terminal sterilization and exposure to the environmental and dynamic stresses expected for the final packaging.
We offer environmental conditioning, accelerated aging and distribution simulation testing, which provide a controlled means to expose a package system to the anticipated environmental and dynamic stresses that the sterile products may encounter in real-world distribution. Additionally, we provide package integrity testing such as whole package bubble emission by vacuum (ASTM D3078) or internal pressurization (ASTM F2096), package seal dye penetration (ASTM F1929 or F3039 for nonporous packaging) to evaluate the efficacy of the sterile barrier packaging after exposure.
Leakage and Torque Testing
Environmental hazards such as freeze/thaw and low pressure (high altitude) exposure can influence the effectiveness of the container/closure interface. To assist in the development process, we offer vacuum leakage testing (ASTM D4991) and altitude simulation (ASTM D6653). For pharmaceutical containers, torque degradation studies (ASTM D2063) can help you assess how much closure retention torque may be lost after exposure to temperature cycling, compression and vibration to ensure that child resistance and senior friendliness are maintained.
Shelf Life Testing
A series of walk-in and reach-in environmental chambers allow us to provide product storage programs that help ensure product integrity throughout the product’s shelf life. From accelerated aging, real-time aging, freeze/thaw and high and low temperature exposure, we offer the chamber capacity to support shelf life testing for materials, products and packaging systems.
Packaging Materials Barrier Properties
We offer numerous tests to characterize adsorption, dissolution, diffusion and desorption of packaging materials, including oxygen transmission rate via ASTM D3985 or ISO 15105-2 and water vapor transmission rate via USP <671>, ASTM F1249, D7709, ISO 15106-2 and ASTM E96. These barrier properties tests help you plan the optimal packaging material choice for specific applications to maximize preservation and prolong the shelf life of your product.
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