Taryag Packaging Validation Tests
Aging And Shelf Life Testing
Shelf life testing is a requirement of packaging performance testing and involves assessing the ability of a package to withstand the test of time. Accelerated aging is an industry-recognized method to achieve the desired performance benchmark, as long as real-time aging is also conducted. Package “age” is simulated by placing it in a temperature- and moisture-controlled incubator for a precalculated period.
Taryag operates multiple temperature-controlled incubators with over 10,000 cubic meters of accelerated aging capacity. Aging process conditions are monitored, recorded, and analyzed to demonstrate performance against the predetermined parameters.
Usability Evaluation
A simple opening of new device packages in sensitive medical settings is crucial. The purpose of Usability Evaluation is to determine how easily users can handle opening a specific package.
ISO 11607 advises performing a documented usability evaluation on your device packaging before it is introduced into a healthcare setting. When healthcare professionals are able to open packages aseptically, there are fewer sterile breaches that could impact patient health, as well as fewer chances of damage or loss of equipment.
Sterile Barrier Packaging Integrity Test
Each part of your medical device’s packaging serves to preserve product sterility. Sterile barrier packaging integrity testing plays a key role in ensuring that sterility by validating sealer qualification, shelf-life, and transit validation as the ultimate pass or fail of every packaging validation. Taryag offers a proven track record of Sterile barrier packaging integrity testing with validated methodologies.
Bubble Leak Test (ASTM F2096)
A bubble leak test is a whole-package integrity cost-effective test that plays a crucial role in validating sealed medical packages: allowing manufacturers to confirm that the contents are protected from the outside world. Bubble leak tests are the most common approach to evaluating sterile barrier integrity for Tyvek(R) pouches or thermoformed trays, and are typically performed as part of a sealer validation or transit and shelf life simulations.
The test is performed by submerging the sample package in water and checking for a steady stream of bubbles that indicate a sterile barrier.
Breach.
Taryag’s laboratories provide bubble leak testing for both non-permeable and permeable materials, although each is tested differently since porous materials require saturation prior to testing.
Dye Leak Test (ASTM F1929)
The ASTM F1929 FDA-recognized dye leak test is used to identify leaks caused by channels between the transparent film and porous sheet material found in most medical device packages and is usually performed during sealer validation or as part of ongoing maintenance. The test is performed using a specialty dye solution that helps identify minute defects within a sterile closure seal. ASTM F1929-12 specifies three methods for detecting and locating unsealed areas on packages, all of which are available at Taryag:
- The injection method
- The edge-drip method
- The eyedropper method
Peel Strength Test (ASTM F88)
Peel strength is a standard test method for determining the seal performance of flexible barrier material. It is not only important for validating package integrity and seal durability, but also in quantifying the force required for opening packages.
The peel strength test is performed by cutting a 0.5/1.0 inch strip from the seal of a sterile package. The test is used throughout a package’s life cycle, first establishing a baseline value and then serving as a checkpoint for how a seal will perform after sterilization, transit, or aging. Finally, the peel test serves as a quantifiable monitoring tool for in-process testing that demonstrates your manufacturing performance over time.
Underwater Vacuum Leak Test (ASTM D3078)
Known by several different names, including submersion leak test, underwater immersion test, or submersion test, the underwater vacuum leak test is the standard method of detecting air leaks in flexible packaging by bubble emission. It is performed by submerging the package in a water-filled vacuum chamber and checking for a steady stream of bubbles that indicate a breach of the sterile barrier. Underwater vacuum leak testing is typically performed on rigid packaging systems, such as bottles or vials, and is most often carried out as part of a closure validation or during transit and shelf life simulations.
Visual Inspection Test (ASTM F1886)
The ASTM F1886 Visual Inspection Test is the standardized evaluation process for assessing the visual integrity of medical packaging materials and systems: ensuring packaging meets stringent quality and safety standards. By visually inspecting components such as seals, labels, and the overall package condition, the Visual Inspection Test helps identify any potential defects, damages, or inconsistencies that could compromise the integrity of the packaging: safeguarding the efficacy and sterility of medical devices.
The Taryag Integrated Approach
By providing medical device and pharmaceutical innovators with an end-to-end development infrastructure that integrates sterilization, validation, packaging, manufacturing, and laboratory services, we help our clients overcome barriers and reduce costs: accelerating their time to market.
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