Nelson Labs offers multiple strength and integrity tests for packages depending on packaging type, configuration, and end points. Strength tests include seal peel and burst testing. Integrity tests include bubble emission and dye migration. Additional tests for whole package integrity are also available. Nelson Labs has significant experience performing this test in compliance with ASTM F88 and ISO 11607 “Packaging for terminally sterilized medical devices,” and we’re actively involved in the ASTM committees.
Please see our Packaging Validation matrix for more information.
Seal Peel Test
The Seal Peel test determines the strength required to peel apart the seals for porous and nonporous packaging. This test is performed in accordance with ASTM F88 “Standard Method for Seal Strength of Flexible Barrier Materials.”
The Burst test determines package strength by pressurizing a package until it bursts. This test meets the requirements of regulatory agencies to demonstrate the strength of a package seal. This test complies with ASTM F1140 “Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages.”
Bubble Emission Test
The Bubble Emission test determines package integrity for porous and nonporous 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 Packaging by Internal Pressurization (Bubble Test).”
Dye Migration Test
The Dye Migration test determines the integrity of the package seal and enables manufacturers to see if there are channels that leak in the pouch seal. This test is designed to be conducted on porous packaging with a clear side. For double and triple packaging configuration, each article should be tested individually. Nelson Labs performs this test in compliance with ASTM F1929 “Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.”
- ISO 11607
- ASTM F88
- ASTM F1140
- ASTM F2906
- ASTM F1929