ASTM F2338-04
(Test Method)Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method
Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method
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 4104 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 4104 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 Pam3s-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.
General Information
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Standards Content (Sample)
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Designation:F2338–04
Standard Test Method for
Nondestructive Detection of Leaks in Packages by Vacuum
1
Decay Method
This standard is issued under the fixed designation F 2338; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope calibrated volumetric airflow meter, the sensitivity of the test
for rigid, nonporous packages is shown to be approximately
1.1 Test Packages—Packages that can be nondestructively
-4 3 -1
10 Pa·m ·s .
evaluated by this test method include:
1.3 Test Results—The test results are qualitative (Accept/
1.1.1 Rigid and semi-rigid non-lidded trays.
Reject).Acceptancecriteriafortestresultsareestablishedfrom
1.1.2 Trays or cups sealed with porous barrier lidding
quantitative baseline vacuum decay measurements obtained
material.
from control, non-leaking packages.
1.1.3 Rigid, nonporous packages.
1.4 Standard Value Units—The values used in this test
1.2 Leaks Detected—This test method is capable of detect-
method are stated in SI units and are to be regarded as standard
ing package leaks using an absolute or differential pressure
units. Values in parentheses are for information only.
transducer leak detector. The sensitivity of a test is a function
1.5 This standard does not purport to address all of the
of the sensitivity of the transducer, the package design, the
safety concerns, if any, associated with its use. It is the
design of the package test fixture, and critical test parameters
responsibility of the user of this standard to establish appro-
of time and pressure. Types and sizes of leaks that may be
priate safety and health practices and determine the applica-
detected for various package systems, as well as test sensitivi-
bility of regulatory limitations prior to use.
ties are described below.These data are based on precision and
bias confirmation studies.
2. Referenced Documents
1.2.1 Trays or Cups (Non-lidded)—Hole or crack defects in
2
2.1 ASTM Standards:
the wall of the tray/cup of at least 50 µm in diameter can be
4
D 996 Terminology of Packaging and Distribution Environ-
detected at a Target Vacuum of 4·10 Pa (400 mbar) using an
ments
absolute pressure transducer test instrument.
E 691 Practice for Conducting an Interlaboratory Study to
1.2.2 Trays Sealed with Porous Barrier Lidding Material—
Determine the Precision of a Test Method
Hole or crack defects in the wall of the tray/cup of at least 100
F 17 Terminology Relating to Flexible Barrier Materials
µm in diameter can be detected. Channel defects in the seal
F 1327 TerminologyRelatingtoBarrierMaterialsforMedi-
area(madeusingwiresof125µmindiameter)canbedetected.
cal Packaging
Severe seal bonding defects in both continuous adhesive and
dot matrix adhesive package systems can be detected. Slightly
3. Terminology
incomplete dot matrix adhesive bonding defects can also be
3.1 Definitions—For definitions used in this test method,
detected. All porous barrier lidding material packages were
4 see Terminologies D 996, F 17, and F 1327.
tested at a Target Vacuum of 4·10 Pa (400 mbar) using an
3.2 Definitions of Terms Specific to This Standard:
absolute pressure transducer test instrument. Using a calibrated
3.2.1 baseline vacuum decay, n—the extent of vacuum
volumetric airflow meter, the sensitivity of the test for porous
-2 3 -1
change within the test chamber over time demonstrated by a
lidded packages is shown to be approximately 10 Pa·m ·s .
control, non-leaking package.
1.2.3 Rigid, Nonporous Packages—Hole defects of at least
3.2.2 control, non-leaking packages, n—packages without
5 µm in diameter can be detected. All rigid, nonporous
4 defects and properly sealed or closed according to manufac-
packagesweretestedatatargetvacuumof5·10 Pa(500mbar)
turer’s specifications.
using a differential pressure transducer test instrument. Using a
1
This test method is under the jurisdiction ofASTM Committee F02 on Flexible
2
Barrier Materials and is the direct responsibility of Subcommittee F02.60 on For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Medical Device Packaging. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Current edition approved June 1, 2004. Published June 2004. Originally Standards volume information, refer to the standard’s Document Summary page on
approved in 2003. Last previous edition approved in 2003 as F 2388 – 03. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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F2338–04
NOTE 1—Further information on the “Leak Test Th
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