1. Scope

1.1 Test PackagesPackages that can be nondestructively evaluated by this test method include:

1.1.1 Rigid and semi-rigid non-lidded trays.

1.1.2 Trays or cups sealed with porous barrier lidding material.

1.2 Leaks DetectedThis test method is capable of detecting package leaks using an absolute or differential pressure transducer leak detector. The sensitivity of a test is a function of the sensitivity of the transducer, the package design, the design of the package test fixture, and critical test parameters of time and pressure. Types and sizes of leaks that may be detected for various package systems, as well as test sensitivities are described below. These data are based on precision and bias confirmation studies.

1.2.1 Trays or Cups (Non-lidded)Hole or crack defects in the wall of the tray/cup of at least 50 m in diameter can be detected at a Target Vacuum of 410 ⁴ Pa (400 mbar) using an absolute pressure transducer test instrument.

1.2.2 Trays Sealed with Porous Barrier Lidding MaterialHole or crack defects in the wall of the tray/cup of at least 100 m in diameter can be detected. Channel defects in the seal area (made using wires of 125 m in diameter) can be detected. Severe seal bonding defects in both continuous adhesive and dot matrix adhesive package systems can be detected. Slightly incomplete dot matrix adhesive bonding defects can also be detected. All porous barrier lidding material packages were tested at a Target Vacuum of 410 ⁴ Pa (400 mbar) using an absolute pressure transducer test instrument. Using a calibrated volumetric airflow meter, the sensitivity of the test for porous lidded packages is shown to be approximately 10 ^-2 Pam ³ s ^-1 .

1.3 Test ResultsThe test results are qualitative (Accept/Reject). Acceptance criteria for test results are established from quantitative baseline vacuum decay measurements obtained from control, non-leaking packages.

1.4 Standard Value UnitsThe values used in this test method are stated in SI units and are to be regarded as standard units. Values 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.

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

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

F17 Terminology Relating to Flexible Barrier Packaging

F1327 Terminology Relating to Barrier Materials for Medical Packaging

Keywords

absolute pressure transducer; barrier performance; block; criteria parameters; differential pressure transducer; flexible packaging; food packages; gauge pressure transducer; hole leaks; holes; leaks; liquid leaks; mask; medical packages; non-destructive testing; package integrity monitoring; package integrity test; permeable packaging; pharmaceutical packages; porous barrier; porous barrier material; porous packaging; pressure change leak testing; pressure transducer; seal integrity monitoring; seal integrity test; seal leaks; semi-rigid thermoformed trays; sterile integrity test; vacuum decay leak testing; vacuum leak testing; volumetric airflow meter;

ICS Code

ICS Number Code 55.180.40 (Complete, filled transport packages)

DOI: 10.1520/F2338-03

ASTM International is a member of CrossRef.