ASTM F2338-09 standard test method explained

ASTM F2338-09 is the Standard Test Method for Non-destructive Detection of Leaks in Packages by Vacuum Decay Method.

ASTM F2338-09

It is a consensus developed by ASTM International (formerly known as American Society for Testing and Materials), an international standards organisation that develops and publishes standards for different materials, products, systems, and services. The organisation does not enforce compliance of its standards, though when referenced by external organisations, they may become mandatory.

ASTM F2338-09

ASTM F2338-09 is recognised by the FDA as the consensus standard for non-destructive detection of leaks in packages.

It is applicable to test a range of non-porous flexible packages, rigid and semi-rigid packaging. Typical containers that can be tested using the Vacuum Decay Method include:

  • Rigid, non-porous containers:
    • Plastic screw capped bottles containing solids (tablets, capsules, powders) or liquids (with significant gas headspace volume)
    • Glass or plastic vials containing liquids (with significant gas headspace volume) or solids (powders)
    • Glass or plastic ampoules containing liquids
    • Glass pre-filled syringes containing liquids or solids (lyophilized powders)
    • Ophthalmic dropper tip bottles containing liquids
    • Blow Fill Seal bottle or strip containing liquid
  • Flexible, non-porous packages including bags and pouches containing solids (powders, medical devices)
  • Sealed cups or trays containing solids (tablets, capsules, powder or devices)
  • Non-lidded, empty cups or trays

*Non-lidded trays and trays and cups sealed with non-porous lidding material can be tested if they can be masked or blocked during testing to create a vacuum chamber. Only then can a change in pressure inside the chamber, because of gas or vapor escaping through a leak path, be measured.

The Sepha Multi-Q is a multi-functional non-destructive leak test solution that can operate in combination with different test methods including the Vacuum Decay Test method as outlined in ASTM F2338-09

More information about the working principle of Vacuum Decay Testing can be found under Vacuum Decay.

More information about the Sepha Vacuum Decay Leak Test solution can be found here: Sepha Multi-Q Vacuum Decay

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