ASTM F2338-07
(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
SIGNIFICANCE AND USE
Leaks in medical device, pharmaceutical and food packages may result in the ingress of unwanted gases (most commonly oxygen), harmful microbiological or particulate contaminants. Package leaks may appear as imperfections in the package components themselves or at the seal juncture between mated components. The ability to detect leaks is necessary to ensure consistency and integrity of packages.
After initial set-up and calibration, the operations of individual tests may be semi-automatic, automatic or manual. The test method permits the non-destructive detection of leaks not visibly detectable. The test method does not require the introduction of any extraneous materials or substances, such as dyes or gases. However, it is important to physically mask or block off any porous barrier surface of the package during the test to prevent a rapid loss of chamber vacuum resulting primarily from gas migration through the porous surface. Leak detection is based solely on the ability to detect the change in pressure inside the test chamber as a result of air egress from the properly masked package when challenged with vacuum conditions.
This test is a useful research tool for optimization of package sealing parameters and for comparative evaluation of various packages and materials. This test method is also applicable to production settings as it is rapid, non-invasive and non-destructive, making it useful for either 100 % on-line testing or to perform tests on a statistical sampling from the production operation.
Leak test results that exceed the permissible limits for the vacuum decay test are indicated by audible or visual signal responses, or both.
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.
1.1.3 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 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 Material - Hole 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.
1.2.3 Rigid, Nonporous Packages - Hole defects of at least 5 m in diameter can be detected. All rigid, nonporous packages were tested at a target vacuum of 5104 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 Pam3s -1.
1.2.4 Flexible, Nonporous Packages - Such packages may also be tested by the vacuum decay method using either an absolute or ...
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Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation:F2338–07
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:
1.2.4 Flexible, Nonporous Packages—Such packages may
1.1.1 Rigid and semi-rigid non-lidded trays.
also be tested by the vacuum decay method using either an
1.1.2 Trays or cups sealed with porous barrier lidding
absolute or differential pressure tranducer test instrument. The
material.
instrument should be selected based on the leak test sensitivity
1.1.3 Rigid, nonporous packages.
desired. Sensitivity data for flexible packages were not in-
1.1.4 Flexible, nonporous packages (see 1.2.4).
cluded in the precision and bias studies, although the use of
1.2 Leaks Detected—This test method is capable of detect-
vacuum decay for testing such packages is well known.
ing package leaks using an absolute or differential pressure
1.3 Test Results—The test results are qualitative (Accept/
transducer leak detector. The sensitivity of a test is a function
Reject).Acceptancecriteriafortestresultsareestablishedfrom
of the sensitivity of the transducer, the package design, the
quantitative baseline vacuum decay measurements obtained
design of the package test fixture, and critical test parameters
from control, non-leaking packages.
of time and pressure. Types and sizes of leaks that may be
1.4 Standard Value Units—The values used in this test
detected for various package systems, as well as test sensitivi-
method are stated in SI units and are to be regarded as standard
ties are described below.These data are based on precision and
units. Values in parentheses are for information only.
bias confirmation studies.
1.5 This standard does not purport to address all of the
1.2.1 Trays or Cups (Non-lidded)—Hole or crack defects in
safety concerns, if any, associated with its use. It is the
the wall of the tray/cup of at least 50 µm in diameter can be
4
responsibility of the user of this standard to establish appro-
detected at a Target Vacuum of 4·10 Pa (400 mbar) using an
priate safety and health practices and determine the applica-
absolute pressure transducer test instrument.
bility of regulatory limitations prior to use.
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
2. Referenced Documents
µm in diameter can be detected. Channel defects in the seal
2
2.1 ASTM Standards:
area(madeusingwiresof125µmindiameter)canbedetected.
D 996 Terminology of Packaging and Distribution Environ-
Severe seal bonding defects in both continuous adhesive and
ments
dot matrix adhesive package systems can be detected. Slightly
E 691 Practice for Conducting an Interlaboratory Study to
incomplete dot matrix adhesive bonding defects can also be
Determine the Precision of a Test Method
detected. All porous barrier lidding material packages were
4 F17 Terminology Relating to Flexible Barrier Packaging
tested at a Target Vacuum of 4·10 Pa (400 mbar) using an
F 1327 TerminologyRelatingtoBarrierMaterialsforMedi-
absolute pressure transducer test instrument. Using a calibrated
3
cal Packaging
volumetric airflow meter, the sensitivity of the test for porous
-2 3 -1
lidded packages is shown to be approximately 10 Pa·m ·s .
3. Terminology
1.2.3 Rigid, Nonporous Packages—Hole defects of at least
3.1 Definitions—For definitions used in this test method,
5 µm in diameter can be detected. All rigid, nonporous
4
see Terminologies D 996,F17, and F 1327.
packagesweretestedatatargetvacuumof5·10 Pa(500mbar)
3.2 Definitions of Terms Specific to This Standard:
using a differential pressure transducer test instrument. Using a
1 2
This test method is under the jurisdiction ofASTM Committee F02 on Flexible For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Barrier Packaging and is the direct responsibility of Subcommittee F02.40 on contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Package Integrity. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved Oct. 1, 2007. Published October 2007. Originally the ASTM website.
3
approved in 2003. Last previous edition approved in 2005 as F 2338 – 05. Withdrawn.
Copyright © ASTM International, 100 Barr
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