ASTM F1886 Seal Integrity Flexible Packages and Pouch Package Testing
ASTM F1886 evaluates unopened seals to determine defects that will affect package integrity. As an ISTA and ISO 17025 certified lab, we realize the importance of ASTM F1886 testing. Meeting the ASTM F1886 integrity requirements can be difficult. We understand the challenges and guide companies through the process.
Keystone Compliance has pricing that is competitive and we offer volume discounts. Keystone also creates an accurate test plan to eliminate expensive over-testing. We are in constant communication throughout the test process. Lastly, Keystone takes a consultative approach during the entire test program.
Summary of ASTM F1886 Seal Integrity Testing
ASTM F1886 is the standard test method for determining the integrity of seals for flexible packaging by visual inspection. Specifically, this ASTM package validation 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 Integrity 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 for 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 Package 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.