The vacuum, bubble test method, as described in Test Method D3078, and various other leak detection methods described elsewhere (Test Method D4991, Guide E432, Guide E479, Test Method E493, Test Method E498, Test Method E499, and Test Method E1603) have been successfully used widely in various industries and applications to determine that a given package is or is not a “leaker.” The sensitivity of any selected leak test method has to be considered to determine its applicability to a specific situation.

The procedures presented in this test method allow the user to carry out package and seal integrity testing with sufficient sensitivity to quantify seals in the previously defined moderate to very fine seal ranges.

By employing seal-isolating leak testing fixtures, packages constructed of various materials can be tested in the full range of seal performance requirements. Design of these fixtures is beyond the scope of this method.

These seal/package integrity test procedures can be utilized as:

A design tool,

For tooling qualification,

Process setup,

Process validation tool,

Quality assurance monitoring, or

Research and development.

1. Scope

1.1 This test method includes several procedures that can be used for the measurement of overall package and seal barrier performance of a variety of package types and package forms, as well as seal/closure types. The basic elements of this method include:

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

D3078 Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission

D4991 Test Method for Leakage Testing of Empty Rigid Containers by Vacuum Method

E432 Guide for Selection of a Leak Testing Method

E479 Guide for Preparation of a Leak Testing Specification

E493 Test Methods for Leaks Using the Mass Spectrometer Leak Detector in the Inside-Out Testing Mode

E498 Test Methods for Leaks Using the Mass Spectrometer Leak Detector or Residual Gas Analyzer in the Tracer Probe Mode

E499 Test Methods for Leaks Using the Mass Spectrometer Leak Detector in the Detector Probe Mode

E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method

E1603 Test Methods for Leakage Measurement Using the Mass Spectrometer Leak Detector or Residual Gas Analyzer in the Hood Mode

F17 Terminology Relating to Flexible Barrier Packaging

F1327 Terminology Relating to Barrier Materials for Medical Packaging

Other Documents

Keywords

blister packaging; bottles; cartridges; flexible packaging; gas barrier performance; helium leak test; impermeable packaging (and materials); integrity monitoring; mass spectrometer; mass spectrometer leak test; mass spectrometer sensor; pass/fail criteria; pass/fail levels; package integrity monitoring; package integrity test; permeable packaging (and materials); pouch packaging; seal integrity monitoring; seal integrity test; sniffer probe leak test; sterility barrier performance; vacuum leak test; vapor barrier performance; rigid packaging; vials; Tracer gas method; Helium; Helium leak testing; Package integrity test; Seal integrity;

ICS Code

ICS Number Code 55.040 (Packaging materials and accessories)

Citing ASTM Standards

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