ASTM F88 Seal Strength Package Testing
ASTM F88, also known as the flexible seal strength test or pouch strength sustainability test, evaluates the strength of seals in flexible barrier materials. As an ISTA and ISO 17025 certified lab, we realize the importance of ASTM F88 testing. Meeting the ASTM F88 seal strength requirements can be difficult. We understand the challenges and guide companies through the process.
Keystone provides the peace of mind that all of your needs will be met. Our pricing is competitive and we offer volume discounts. Keystone Compliance also creates an accurate test plan to eliminate expensive over-testing. We are in constant communication throughout the test process.
Summary of ASTM F88 Seal Strength Validation Testing
Flexible package and pouch seal strength testing determines various considerations that exist with the seal strength testing of packages. ASTM F-88 regulatory compliance testing measures the force required to separate a test strip of material containing the sale. This standard F88 test method is also used to identify the mode of specimen failure.
ASTM F88 Seal Strength Definitions
The standard calls out three very important definitions. Two of these definitions deal with the actual seal strength.
The maximum seal strength is defined as the maximum force per unit width of seal required to separate progressively a flexible material from another material. The other material can either be rigid or flexible.
The average seal strength is the average force per unit width of seal required to separate progressively a flexible material from another material. This separation is evaluated under the conditions of testing.
Flexible is defined as a material with flexural strength and thickness permitting a turn back at an approximate 180-degree angle.
The Importance of Seal Strength and ASTM F88 Package Testing
Seal strength is an essential component of package validation. Seal strength regulatory testing measures package integrity. It also measures the opening force required to open a package. The ability of a package to produce consistent seals is also assessed.
The strength of the seal must be within an acceptable tolerance. It must be strong enough to protect the contents of the packaging. At the same time, it must be minimum to the point of permitting the opening of the package with an acceptable amount of force.
During ASTM compliance testing, the seal strength is not the only point of evaluation. A bending component must also be considered. The package must be held at different angles to assess the impact of opening the package.
Three Techniques of ASTM F88 Integrity Testing
Seal strength testing involves the use of three separate techniques.
Technique A – unsupported method. This testing requires each tail of the specimen to be secured in opposing grips. The seal remains unsupported while the test is conducted.
Technique B – supported by 90 degrees method. Each tail of the package being tested is supported in opposing grips. The seal remains hand-supported at a ninety-degree angle. This angle is perpendicular to the tails while the test is being conducted.
Technique C – supported by 180 degrees method. Technique C is similar to Technique B. Under Technique C, the least flexible tail is supported flat against a rigid alignment plate held in one grip. The more flexible tail is folded 180 degrees over the seal and is held in the opposing grip while the package is tested.
The objective of these techniques is to measure the strength of seals in flexible barrier materials. The intent is to determine seal strength. This is completed by measuring the force required to peel a seal apart while pulling on the ends of a strip of material containing the seal.
It is important to note that the pulling process may or may not result in the desired mode of strip failure. During the laboratory testing cycles, the grips are continuously moved apart. This is done so at a set rate while the force required to extend the ends of the strip are monitored.
Extension of the specimen ends can cause one or a combination of the following effects within the specimen. The material at the edge of the seal can tear or break. There can be an elongation of the material. There can also be a break or tear of the material remote from the seal.
Expert ASTM F88M Seal Strength Flexible Barrier Materials Laboratory 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. Our team strives to give our customers more time and energy on product development instead of testing. Receiving ASTM F88 certification can be challenging. Let us walk you through our proven process.
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 package testing and medical device package testing.