Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas

Importancia y uso:

5.1 The vacuum, bubble test method, as described in Test Method D3078, and various other leak detection methods described elsewhere (Test Method D4991, Guide E432, 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.

5.2 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 fine seal ranges.

5.3 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.

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

5.4.1 A design tool,

5.4.2 For tooling qualification,

5.4.3 Process setup,

5.4.4 Process validation tool,

5.4.5 Quality assurance monitoring, or

5.4.6 Research and development.

Subcomité:

F02.40

Referida por:

F2097-23, F2097-23, E3336-22

Volúmen:

15.10

Número ICS:

55.040 (Packaging materials and accessories)

Palabras clave:

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; package integrity monitoring; package integrity test; pass/fail criteria; pass/fail levels; permeable packaging (and materials); pouch packaging; rigid packaging; seal integrity monitoring; seal integrity test; sniffer probe leak test; sterility barrier performance; syringes; vacuum leak test; vapor barrier performance; vials;