Harmful biological or particulate contaminants may enter the package through incomplete seals or imperfections such as pinholes or cracks in the trays.

After initial instrument set-up and calibration, the operations of individual tests and test results do not need operator interpretation. The non-destructive nature of the test may be important when testing high value added products.

Leak test results that exceed the permissible threshold setting are indicated by audible or visual signal responses, or both, or by other means.

This non-destructive test method may be performed in either laboratory or production environments. This testing may be undertaken on either a 100 % or a statistical sampling basis. This test method, in single instrument use and current implementation, may not be fast enough to work on a production packaging line, but is well suited for statistical testing as well as package developmental design work.

1. Scope

1.1 This non-destructive test method detects leaks in non-porous rigid thermoformed trays, as well as the seal between the porous lid and the tray. The test method detects channel leaks in packages as small as 100 m (0.004 in.) diameter in the seal as well as 50 m (0.002 in.) diameter pinholes, or equivalently sized cracks in the tray, subject to trace gas concentration in the package, package design and manufacturing tolerances.

Note 1—This test method does not claim to challenge the porous (breathable) lidding material. Any defects that may exist in the porous portion of the package will not be detected by this test method.

1.2 The values stated in SI units are to be regarded as standard units. Values in parentheses are for information only.

1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

ASTM Standards

D996 Terminology of Packaging and Distribution Environments

F17 Terminology Relating to Flexible Barrier Packaging

F1327 Terminology Relating to Barrier Materials for Medical Packaging

Keywords

basal flow; carbon dioxide (CO₂) leak testing; flexible packaging; infrared CO₂ sensor; medical packaging; non-destructive testing; package integrity monitoring; package integrity test; pass/fail criteria; pass/fail levels; permeable packaging; pinhole leaks; porous barrier; porous lids; porous packaging; rigid thermoformed trays; sealing membrane performance; seal integrity monitoring; seal integrity test; seal leaks; sterile integrity tests; trace gas leak testing;

ICS Code

ICS Number Code 11.020 (Medical sciences and health care facilities in general); 19.100 (Non-destructive testing)

Citing ASTM Standards

[Back to Top]