Package Integrity Testing

Package Integrity Testing is crucial for evaluating the sterility and shelf life of a packaged product. Package integrity is especially critical for sterile pharmaceutical products. Establishing the correct criteria for evaluating the packaging system is a fundamental step in determining the integrity of the packaging. Depending on the packaging system being evaluated, multiple tests may be required to validate the packaging system. An evaluation of the product and packaging properties will need to be conducted to appropriately determine the correct testing methods.

What is Package Integrity Testing?

Package Integrity Testing is the evaluation of packaging to meet the desired amount of protection or containment of the packaging components. The physical capability of the packaging is evaluated to measure the protection of the package’s contents. This is performed by measuring: microbiological, chemical, product, and barrier attributes. Testing for package integrity provides assurance that a package is sealed properly, the product within is contained, and foreign contaminants remain outside the packaging system.

How To Test for Package Integrity

Bubble Emission

To evaluate flexible packaging for gross leaks, a bubble emission test is performed. Bubble leak testing is used to evaluate flexible packaging systems including sterile barrier Tyvek(R) pouches or thermoformed trays. Bubble testing assesses the entire sterile barrier system’s ability to maintain a sterile barrier without being compromised by tears, holes, or improper seals. 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).

Burst Test

Package Burst Testing is a destructive test that is used to evaluate nonporous packaging made from films, foils, or laminates. These packages can be either flexible or trayed. This type of testing can be a valuable resource for identifying weak points in the packaging system itself and defining the minimum amount of pressure that would cause the packaging system to burst. The ASTM standard used for burst testing is ASTM F2095 – Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates.

Dye Penetration

Dye Penetration Testing is a destructive package integrity test that is applied to a transparent material that has been sealed to a porous material. 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 then be visually assessed using this type of testing. There are three different dye penetration methodologies with Method A being the preferred testing methodology.

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.
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.

Why Purple Diamond?

Package Integrity Testing is completed on site at Purple Diamond and can be tailored to your specific testing needs. By testing for your packaged product’s specific needs, we can simulate the conditions that your packaged goods will be exposed to during the product’s lifecycle. Purple Diamond is able to test packaged products as a single unit or as part of a full pallet load, offering Materials Testing in conjunction with Package Integrity Testing to determine how exactly a product will operate within its protective barrier.

Our engineers work with you throughout the entire testing process to address any concerns, consult alongside you to offer recommendations, and ultimately help you create the best packaging for your product. Purple Diamond is committed to delivering high-quality results as we develop a comprehensive solution to your specific package integrity testing needs.

Accreditations

Achieving ISO 17025 Accreditation is the pinnacle in third-party laboratory testing accreditation. It confirms that the facility has management, quality, and technical systems in place to ensure accurate and reliable analyses.
ISTA is revered as the certification standard for package testing for distribution. ISTA’s Testing Protocol remains a series of testing methodologies and standards well recognized within the packaging community.
A select few companies are authorized by PHMSA as an approved third-party packaging testing laboratory in accordance with Hazardous Materials Regulations, critical to ensuring safe transport of dangerous goods.

Affiliations

With over 12,000 standards globally, ASTM International’s fully transparent standards development enhances performance and confidence in consumer choices.
The Technical Association of Pulp and Paper Industry’s peer-reviewed standards improve production through operational methods and industry recognized best practices.

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