Document Center is acquired by Nimonik

Changes from the previous issue

A redline edition is available for this document, with all changes visible. Ask Document Center Inc. for more information.

Scope

1.1 This test method covers the detection of gross leaks in packaging. Method sensitivity is down to 250 μm (0.010 in.) with an 81 % probability (see Section 11). This test method may be used for tray and pouch packages.

1.2 The sensitivity of this test method has not been evaluated for use with porous materials other than spunbonded polyolefin or with nonporous packaging.

1.3 This test method is destructive in that it requires entry into the package to supply an internal air pressure

1.4 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.

1.5 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.

Notes

Claudia's Notes:
What is a bubble leak test?  You put a packaging or sterile barrier system under water with gently increasing pressurization, looking for evidence of air bubbles.  It is a destructive test, used to confirm that medical packages are providing sterility.

Significance and Use

The internal pressurization test method provides a practical way to examine packages for gross leaks.

This test method is extremely useful in a test laboratory environment where no common package material/size exists.

This test method may apply to large or long packages that do not fit into any other package integrity test method apparatus.

This test method may be used as a means to evaluate package integrity. Package integrity is crucial to consumer safety since heat sealed packages are designed to provide a contamination free or sterile environment, or both, to the product.

This test method may be used to detect substrate holes and channels.

Keywords

bubble test; internal pressurization; package integrity; Bubble test; Gross leak testing; Internal pressure/testing; Leak testing--packaging applications/containers; Medical/surgical packaging materials; Package integrity test; Porous packaging materials; ICS Number Code 19.060 (Mechanical testing); 55.040 (Packaging materials and accessories)

To find similar documents by ASTM Volume:

15.10 (Packaging; Flexible Barrier Packaging)

To find similar documents by classification:

19.060 (Mechanical testing Including testing equipment Mechanical testing of metals, see 77.040.10)

55.040 (Packaging materials and accessories Including wrappers, paper, films, foils, cords, sealing devices, cushioning, etc. Adhesive tapes for general purposes, see 83.180)

This document comes with our free Notification Service, good for the life of the document.

This document is available in either Paper or PDF format.