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Seal Integrity Package Testing

The integrity of seals is an important component of package testing. As a leader in package testing, Keystone Compliance partners with companies to complete assessments and achieve certifications. Our proven process starts with the test plan and ends with the test report.

The remainder of this page speaks to the various considerations that exist with the seal integrity testing of packages. 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 remainder of this document speaks to seal integrity package testing, specifically to ASTM F1886.
ASTM F1886 is the standard test method for determining the integrity of seals for flexible packaging by visual inspection. Specifically, this ASTM package testing standard covers the determination of channels in the package seal down to a width of 0.003 inches. The probability of this testing is 60-100%.

There are several factors that determine the ability to visually detect channel defects in package seals. One factor is the actual size of the channel in the package. Another factor is the degree of contrast in the areas that are sealed and unsealed.

The amount of adhesion in the two package layers can impact the accuracy of the visual inspection. The type of adhesive used to seal the two package layers is also a factor. The visual environment can also impact the inspection. For instance, the light angle can play a role. The use of magnification and degree of inspection.

Visual inspection can be influenced by the actual training, eyesight and experience of the inspector. Lastly, different materials provide different visuals. Some materials provide easier observations of deficiencies than others. It is important to note that this test is applicable to packages with at least one transparent side.

The actual inspection is to take place at a distance between 12 inches and 18 inches. Test professionals can use magnification devices such as eye loops. These are to be used as an analytical tool to characterize identified seal defects and deficiencies.

Significance of ASTM F1886/1886M Package Testing

The seal integrity package testing standard takes into consideration a number of potential causes of defects. Visual inspections are most of the time one of the first alerts that problems in the heat-sealing process exist. These inspections also point to package integrity issues as well. The variables in the process are numerous.

The equipment and materials used in the process might not provide a good match. Some equipment lacks compatibility with certain materials. The environment plays a significant role. Temperature and humidity can change the properties of materials. For instance, cold temperatures can make materials more brittle.

Probable Causes of Defects

ASTM F-1886 Seal Testing includes an appendix that covers some of the reasons deficiencies can occur. Unsealed areas occur when the heat seal is not made to the package. It can also be made when a seal that had been made is ruptured. There are several potential causes to unsealed areas.

One cause is a misalignment of the package to the seal bar or platen. A misalignment of the seal bar or platen to the mating seal surface can also cause defects. Impurities that get in the way of the sealing material can also cause defects.

Over-sealed areas can cause defects in flexible packages. These are often caused by a combination of too much pressure, too much heat or dwell time. Areas that have been over-sealed can often become brittle, causing the packaging to crack.

Other potential causes of defects include tears and pinholes, wrinkles, cracks, fold-overs and channels. All of these physical defects can impact the ability of the packaging to protect the contents. In medical packaging and sterile packaging, this can have traumatic results.

ASTM F1886M Seal Integrity of Flexible Barrier Materials Testing

As an industry leader in package testing, Keystone Compliance can meet all of your flexible barrier package testing needs. Our team understands the medical packaging requirements inside and out. We streamline the process. Receiving ASTM F1886 certification can be challenging. We can walk you through our proven and successful process.

As experts in medical package testing, we know what to look for when evaluating the seals on 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.