ASTM F2338-05
(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 Packages—Packages 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.
1.1.3 Rigid, nonporous packages.
1.1.4 Flexible, nonporous packages (see 1.2.4).
1.2 Leaks Detected—This 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 μm in diameter can be detected at a Target Vacuum of 4·104 Pa (400 mbar) using an absolute pressure transducer test instrument.
1.2.2 Trays Sealed with Porous Barrier Lidding Material—Hole or crack defects in the wall of the tray/cup of at least 100 μm in diameter can be detected. Channel defects in the seal area (made using wires of 125 μm 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.
1.2.3 Rigid, Nonporous Packages—Hole defects of at least 5 μm in diameter can be detected. All rigid, nonporous packages were tested at a target vacuum of 5·104 Pa (500 mbar) using a differential pressure transducer test instrument. Using a calibrated volumetric airflow meter, the sensitivity of the test for rigid, nonporous packages is shown to be approximately 10-4 P·am3s -1.
1.2.4 Flexible, Nonporous Packages—Such packages may also be tested by the vacuum decay method using either an absolute or differential pressure tranducer test instrument. The instrument should be selected based on the leak test sensitivity desired. Sensitivity data for flexible packages were not included in the precision and bias studies, although the use of vacuum decay for testing such packages is well known.
1.3 Test Results—The 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 Units—The 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.
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Designation:F2338–05
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 using a differential pressure transducer test instrument. Using a
calibrated volumetric airflow meter, the sensitivity of the test
1.1 Test Packages—Packages that can be nondestructively
for rigid, nonporous packages is shown to be approximately
evaluated by this test method include:
-4 3 -1
10 Pa·m ·s .
1.1.1 Rigid and semi-rigid non-lidded trays.
1.2.4 Flexible, Nonporous Packages—Such packages may
1.1.2 Trays or cups sealed with porous barrier lidding
also be tested by the vacuum decay method using either an
material.
absolute or differential pressure tranducer test instrument. The
1.1.3 Rigid, nonporous packages.
instrument should be selected based on the leak test sensitivity
1.1.4 Flexible, nonporous packages (see 1.2.4).
desired. Sensitivity data for flexible packages were not in-
1.2 Leaks Detected—This test method is capable of detect-
cluded in the precision and bias studies, although the use of
ing package leaks using an absolute or differential pressure
vacuum decay for testing such packages is well known.
transducer leak detector. The sensitivity of a test is a function
1.3 Test Results—The test results are qualitative (Accept/
of the sensitivity of the transducer, the package design, the
Reject).Acceptancecriteriafortestresultsareestablishedfrom
design of the package test fixture, and critical test parameters
quantitative baseline vacuum decay measurements obtained
of time and pressure. Types and sizes of leaks that may be
from control, non-leaking packages.
detected for various package systems, as well as test sensitivi-
1.4 Standard Value Units—The values used in this test
ties are described below.These data are based on precision and
method are stated in SI units and are to be regarded as standard
bias confirmation studies.
units. Values in parentheses are for information only.
1.2.1 Trays or Cups (Non-lidded)—Hole or crack defects in
1.5 This standard does not purport to address all of the
the wall of the tray/cup of at least 50 µm in diameter can be
4
safety concerns, if any, associated with its use. It is the
detected at a Target Vacuum of 4·10 Pa (400 mbar) using an
responsibility of the user of this standard to establish appro-
absolute pressure transducer test instrument.
priate safety and health practices and determine the applica-
1.2.2 Trays Sealed with Porous Barrier Lidding Material—
bility of regulatory limitations prior to use.
Hole or crack defects in the wall of the tray/cup of at least 100
µm in diameter can be detected. Channel defects in the seal
2. Referenced Documents
area(madeusingwiresof125µmindiameter)canbedetected.
2
2.1 ASTM Standards:
Severe seal bonding defects in both continuous adhesive and
D 996 Terminology of Packaging and Distribution Environ-
dot matrix adhesive package systems can be detected. Slightly
ments
incomplete dot matrix adhesive bonding defects can also be
E 691 Practice for Conducting an Interlaboratory Study to
detected. All porous barrier lidding material packages were
4 Determine the Precision of a Test Method
tested at a Target Vacuum of 4·10 Pa (400 mbar) using an
F17 Terminology Relating to Flexible Barrier Materials
absolute pressure transducer test instrument. Using a calibrated
F 1327 TerminologyRelatingtoBarrierMaterialsforMedi-
volumetric airflow meter, the sensitivity of the test for porous
-2 3 -1
cal Packaging
lidded packages is shown to be approximately 10 Pa·m ·s .
1.2.3 Rigid, Nonporous Packages—Hole defects of at least
3. Terminology
5 µm in diameter can be detected. All rigid, nonporous
4
3.1 Definitions—For definitions used in this test method,
packagesweretestedatatargetvacuumof5·10 Pa(500mbar)
see Terminologies D 996,F17, and F 1327.
1
This test method is under the jurisdiction ofASTM Committee F02 on Flexible
2
Barrier Materials and is the direct responsibility of Subcommittee F02.40 on For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Package Integrity. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Current edition approved April 1, 2005. Published April 2005. Originally Standards volume information, refer to the standard’s Document Summary page on
approved in 2003. Last previous edition approved in 2004 as F 2338 – 04. the ASTM website.
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