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 deciding the integrity of the packaging. Depending on the packaging system being evaluated, multiple tests may be needed to confirm the packaging system. An evaluation of the product and packaging properties will need to be conducted to appropriately decide 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 supplies assurance that a package is sealed properly, the product within is held, and foreign contaminants stay outside the packaging system. Overall, testing for package integrity will save your company thousands of dollars from potential defects or failures later. It is important to make sure your packaged product can manage the conditions it will face along the way.
How To Test for Package Integrity
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 support 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).
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 finding weak points in the packaging system itself and 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 Package Integrity 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 for Package Integrity Testing?
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 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 decide how exactly a product will run within its protective barrier.
Our engineers collaborate 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.
At Purple Diamond, we offer a free consultation or a guided tour of our facilities. If you’re nearby, feel free to drop by and see our packaging and team. Consultations can be done over the phone or on zoom, so choose what suits you best. To get in touch, go to our Contact Us page and fill out the form or book an appointment using the calendar below. Our goal is to assist you in any way possible, so please don’t hesitate to contact us. Our website contact form is located at www.purple-diamond.com/contact-us, but we promise to get back to you soon, no matter which method of communication you choose. Thank you so much for reading down this far and thank you for considering Purple Diamond as your dedicated testing, engineering, and design facility for all your packaging needs. A complete list of all the standard tests that we supply here on site can be found under the “Standard Test Lists” Tab at the top of this website. This is helpful when you are deciding which test you need. But of course, remember that we are just a phone call, an email, or a contact request form away from helping you. Thank you again.
At Purple Diamond, we offer a free consultation or a guided tour of our facilities. If you’re nearby, feel free to drop by and see our packaging and team. Consultations can be done over the phone or on zoom, so choose what suits you best. To get in touch, go to our Contact Us page and fill out the form or book an appointment using the calendar below. Our goal is to assist you in any way possible, so please don’t hesitate to contact us. Our website contact form is located at www.purple-diamond.com/contact-us, but we promise to get back to you soon, no matter which method of communication you choose.