Package Integrity Testing
When it comes to protecting your life-saving pharmaceutical products and medical devices, packaging is the final, vital line of defense. Even the slightest packaging failure can compromise product sterility and patient safety. Package integrity testing is used to ensure your packaging systems can protect your products from contamination and leakage. Analyzing both the physical and barrier properties of your packaging, our team at Purple Diamond will ensure your packaging protects so that your product remains shelf-stable, sterile, & safe throughout its lifecycle.
What is Package Integrity Testing?
Advanced Testing for Reliable Packaging Protection
Package integrity testing assesses key factors of your packaging systems, including their chemical and barrier properties, giving you confidence that your packaging is properly sealed, contamination-free, and capable of withstanding real-world conditions. Distinctly separate from package strength testing, package integrity testing analyzes vulnerabilities that may impact the sterility of your product and the durability of your packaging’s protective barrier. This is especially useful in industries that manufacture life-saving products that rely on sterility to remain effective, such as pharmaceuticals and medical devices.
At Purple Diamond, our package integrity testing services include bubble emission testing to detect gross leaks in flexible packaging, burst testing to evaluate the pressure resistance of nonporous packages, and dye penetration testing to uncover seal defects in sterile barrier systems. With these methods, we ensure your packaging meets the highest standards of protection and performance.
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Bubble Emission Testing
A bubble emission test evaluates flexible packaging for gross leaks. Flexible packaging systems that may benefit from bubble leak testing include sterile barrier Tyvek(R) pouches or thermoformed trays. During this test, the packaging’s ability to support a sterile barrier without being compromised by tears, holes, or improper seals is analyzed. The ASTM standard used for bubble emission testing is ASTM F2096 – Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test).
Bubble Emission Testing
ASTM F2095
Package burst testing is a destructive test method that evaluates nonporous, flexible or trayed packaging made from films, foils, or laminates. This type of testing is a valuable resource for finding weak points in the packaging system itself by defining the smallest amount of pressure that would cause the packaging system to burst. The ASTM standard used for bursting testing is ASTM F2095 – Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates.
Dye Penetration Testing
Dye penetration testing is a destructive package integrity test. A dye solution is injected into the package along the longest edge of the inner seal. Once the dye has been injected, a visual inspection is performed looking for channels of dye dispersed across the package’s heat seals. Potential defects within the seal of a sterile barrier system can be visually assessed using this type of testing. There are three different dye penetration methodologies:
- Method A – Injection: The dye solution is injected into the package along the longest seal edge and the seal is inspected for channeling or leaks. This is the preferred testing method by experts.
- Method B – Edge Dip: The edge of the package is physically dipped into the dye solution and then observed for any wicking upward for any channels.
- Method C – Eye Dropper: After separating the two materials, an eye dropper is used to place a bead of dye solution along the outside edge of the package seal to detect a channel in the seal.
The ASTM standard used for dye penetration testing is ASTM F1929 – Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.
Is Your Packaging Up to the Challenge?
At Purple Diamond, we offer advanced testing to ensure your packaging system provides maximum protection, preserving sterility and preventing contamination. Contact us today to learn how our testing services can help you maintain safety, sterility, and shelf-life integrity.
Why Purple Diamond?
Package integrity testing is completed on-site in our ISO-certified lab. By testing your packaged product’s specific needs and unique characteristics, we can simulate the conditions your packaged goods will be exposed to during the product’s lifecycle. Our experts can evaluate packaged products as a single unit or as part of a full pallet load, offering materials testing in conjunction with package integrity testing to ensure comprehensive data and analysis regarding your packaging’s ability to protect against environmental and distribution hazards. A certified ISTA and ASTM lab, contact us today to discover comprehensive package testing.
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Whether you’re looking for a team of experts to engineer your new packaging product for optimal sustainability, or seeking a team who can ensure your products stay safe and secure during transport, Purple Diamond can help.
