Air Leak Test Standards

5.1 Leaks in medical device, pharmaceutical, and food packages may result in the ingress of unwanted gases (most commonly oxygen), harmful microbiological, or particulate contaminants. Package leaks may appear as imperfections in the package components themselves or at the seal...

5.1 Leaks in medical device, pharmaceutical, and food packages may result in the ingress of unwanted gases (most commonly oxygen), harmful microbiological, or particulate contaminants. Package leaks may appear as imperfections in the package components themselves or at the seal...

Leaks in medical device, pharmaceutical, and food packages may result in the ingress of unwanted gases (most commonly oxygen), harmful microbiological, or particulate contaminants. Package leaks may appear as imperfections in the package components themselves or at the seal juncture...

Test Packages-Packages that can be nondestructively evaluated by this test method include: Rigid and semi-rigid non-lidded trays. Trays or cups sealed with porous barrier lidding material. Rigid, nonporous packages. Flexible, nonporous packages. Leaks Detected-This test...

1.1 Test PackagesPackages that can be nondestructively evaluated by this test method include: 1.1.1 Rigid and semi-rigid non-lidded trays. 1.1.2 Trays or cups sealed with porous barrier lidding material. 1.1.3 Rigid, nonporous packages. 1.1.4 Flexible, nonporous packages (see 1.2.4)....