Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method

Importancia y uso:

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 juncture between mated components. The ability to detect leaks is necessary to ensure consistency and integrity of packages.

5.2 After initial set-up and calibration, individual test operation may be semi-automatic, automatic, or manual. The test method permits non-destructive detection of leaks not visibly detectable. The test method does not require the introduction of any extraneous materials or substances, such as dyes or gases. However, it is important to physically mask or block off any package porous barrier surface during the test to prevent rapid loss of chamber vacuum resulting primarily from gas migration through the porous surface. Leak detection is based solely on the ability to detect the change in pressure inside the test chamber resulting from gas or vapor egress from a package challenged with vacuum.

5.3 This test is a useful research tool for optimizing package sealing parameters and for comparatively evaluating various packages and materials. This test method is also applicable to production settings as it is rapid, non-invasive, and non-destructive, making it useful for either 100 % on-line testing or to perform tests on a statistical sampling from the production operation.

5.4 Leak test results that exceed the permissible limits for the vacuum decay test are indicated by audible or visual signal responses, or both.

Subcomité:

F02.40

Referida por:

F2097-23, F2097-23, E3336-22

Volúmen:

15.10

Número ICS:

55.180.40 (Complete, filled transport packages)

Palabras clave:

absolute pressure transducer; barrier performance; block; criteria parameters; differential pressure transducer; flexible packaging; food packages; gauge pressure transducer; hole leaks; holes; leaks; liquid leaks; mask; medical packages; non-destructive testing; package integrity monitoring; package integrity test; permeable packaging; pharmaceutical packages; porous barrier; porous barrier material; porous packaging; pressure change leak testing; pressure transducer; seal integrity monitoring; seal integrity test; seal leaks; semi-rigid thermoformed trays; sterile integrity test; vacuum decay leak testing; vacuum leak testing; volumetric airflow meter;