Bubble Emission Package Testing
The ASTM D3078 package testing standard outlines the process of determining leaks in flexible packages by bubble emission. As an ISTA and ASTM-certified staff, our testing experts very significant knowledge in flexible package testing. We have developed a process that guides our customers from test plan to test report.
The remainder of this page speaks to the various considerations that exist with the testing of flexible packages using bubble emission. If you need package testing, request a quote. If you are unsure of where to start, contact us. We look forward to working with you to help you certify your packages through our perfected process.
The scope of ASTM D3078 is to identify gross leaks in flexible packaging that contains a headspace gas. As the standard points out, small leaks may not always be identified by using this procedure. Viscoelastic effects on the products, or entrapped air, become significant and prevent passage through small openings.
The product may actually plug small leaks when positive pressure inside the pouch is drawn away using a vacuum. The size of the leak that can be observed with this test method is determined by two primary factors. First, the nature of the packaging material will impact the observation of leaks. Second, the test parameters selected can be a factor.
What is Defined as a Leak?
ASTM D-3078 bubble leak testing defines a leak as any opening in a flexible package that either allows their contents to escape or permits substances to enter.
Test Equipment Overview
There are two primary pieces of equipment necessary to complete this bubble leak packaging test. The first element of equipment needed is the actual immersion fluid. The selection of an appropriate immersion fluid is important.
The most common examples of bubble leak testing immersion fluids are water, denatured alcohol, mineral oil and water treated with a wetting agent. It is crucial that the fluid not degrade the packaging. Fluids with a low surface tension are generally more sensitive.
The second and most complex piece of equipment is the vacuum chamber. The chamber must be transparent. It must also be capable of withstanding approximately one atmosphere pressure differential. The chamber must also be fitted with a vacuum-tight cover.
The chamber cover must be fitted with several components. These include a vacuum gage, an inlet tube from a vacuum source and an outlet tube to the atmosphere. The inlet and outlet tubes are fitted with hand valves. Attached to the underside of the cover is a transparent plate. This plate must approximate the inside dimensions of the container.
The cover should be such a distance from the top of the container that when it is two-thirds filled with fluid, the attached plate will be positioned in one inch of water.
The ASTM D3078 Test Report Contents
Upon completion of testing, a test report is generated. This report will contain the following information. First is a statement that the test was conducted in compliance with the ASTM D3078 test method or a description of the deviations from this test method. The report will also identify the test article as well as its material.
Information from the testing will be included such as the immersion liquid used and the maximum vacuum level. There will be a comment regarding the approximate average and range of sample expansions when at maximum vacuum. The time period the test item is at maximum vacuum is also recorded.
There will be a clarification statement outlining whether or not a leak occurred. If a leak or leaks did occur, the locations of each will be described. The number of flexible packages tested will also be included in the test report.
Lastly, if testing is completed to verify compliance with requirements, a statement that the sample did or did not meet requirements is included.
ASTM D-3078 Immersion Bubble Leak Testing
As an industry leader in package testing, Keystone Compliance can meet all of your flexible package testing needs. Our team understands the packaging requirements inside and out. This includes medical packaging. We streamline the bubble leak process. Receiving ASTM D3078-02 certification can be challenging. We can walk you through our proven and successful process.
As experts in package testing, we know what to look for when evaluating whether leaks exist in flexible packaging. We also understand and can explain which packages meet the requirements and which ones do not. Our lab is ISTA and ASTM certified. Our test experts are certified and our quality system in ISO 17025.
To get started, request a quote to experience the Keystone Compliance difference. If you have questions, contact us. Rely on our expertise to guide you through flexible package testing and medical device package testing.