Integrity and Strength Test

Integrity and Strength Test

EUROLABoffers multiple strength and integrity tests for packages depending on packaging type, configuration, and endpoints. Strength tests include sealing shell and burst test. Integrity tests include bubble emission and dye migration. Additional testing for complete package integrity is also available.

Integrity and Strength Test

Seal Test

The Seal Peel test determines the strength required to separate seals for porous and non-porous packages. This test meets the requirements for regulatory agencies to demonstrate the strength of a package seal. This test was conducted in accordance with ASTM F88 "Standard Method for Sealing Strength of Flexible Barrier Materials". 

The Seal Peel test is performed by cutting a 1 inch segment of samples from the appropriate gasket (backer and / or manufacturing seal). The samples are then placed on Instron handles and the machine separates the seal using three possible methods: unsupported, 90 ° supported, and 180 ° supported.

Explosion Test

The pack burst test determines the strength of the pack by pressurizing a pack until it bursts. This test meets the requirements of regulatory agencies to demonstrate the strength of a pack seal. This test complies with ASTM F1140 "Standard Test Methods for Internal Pressure Failure Resistance of Unlimited Packages".

In the blasting test, porous packages are prepared by placing a tape on the porous surface in order to reduce the escape rate of the air. Installation packages can be used to experimentally determine the correct pressure, flow, and time required for samples to burst. A probe is inserted into the sample pack through a pack port and the machine inflates the pack until it explodes. The machine records the burst pressure. The explosion failure location is also recorded.

Bubble Emission Test

The Bubble Emission test determines package integrity for porous and non-porous materials. It meets the requirements of regulatory agencies to demonstrate package integrity. This test complies with ASTM F2096 "Standard Test Method for Detecting Gross Leaks in Internal Pressure Packaging (Bubble Test).

Bubble Emission testing begins by setting the pressure gauge to at least 10 inches of water. A packaging port is attached to the middle of the sample and a probe is inserted through the port. The pack is then dipped in water and inflated. Evidence of bubble emission through the package is considered a failure.

Paint Migration Test

Dye Penetration testing determines the integrity of the package seal and allows manufacturers to see if there are any leaking channels in the bag seal. This test is designed to be performed on porous packaging with an open side. For double and triple packaging configuration, each product must be tested individually. EUROLABperforms this testing in compliance with ASTM F1929 “Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.”

In the Dye Migration test, a needle is inserted through the package and a syringe is injected into the dye solution. The package is placed in a vertical position so that the paint comes into contact with the seal. The weight of the dye solution is maintained against the seal for a certain period of time.

The pack is redirected so that each part of the seal is in contact with the same amount of paint. Evidence of paint slipping off the seals is considered a failure.

Applicable Standards

  • ISO 11607
  • ASTM F88
  • ASTM F1140
  • ASTM F2906
  • ASTM F1929

EUROLAB, with its highly expert team and internationally accredited laboratories, Integrity and Strength Test It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.

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