ASTM F2227-13(2021)

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F2227 − 13 (Reapproved 2021)
Standard Test Method for
Non-Destructive Detection of Leaks in Non-sealed and
Empty Packaging Trays by CO Tracer Gas Method
This standard is issued under the fixed designation F2227; 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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope 3.2 Definitions of Terms Specific to This Standard:
3.2.1 trace gas, n—a compound selected solely for use to
1.1 This non-destructive test method detects pinhole leaks
identify leakage flow.
in trays, as small as 50 µm (0.002 in.) in diameter, or
equivalently sized cracks, subject to trace gas concentration in
4. Summary of Test Method
the tray, tray design and manufacturing tolerances.
4.1 This test method utilizes CO sensing techniques in the
1.2 The values stated in SI units are to be regarded as
detection of a CO trace gas to quantify leaks in medical
standard. The values given in parentheses after SI units are
packaging trays. The test method provides a qualitative
provided for information only and are not considered standard.
(accept/reject) inspection method to evaluate trays for pinholes
1.3 This standard does not purport to address all of the
and cracks. Further information on the “Leak Test Theory”
safety concerns, if any, associated with its use. It is the
may be found in Annex A1.
responsibility of the user of this standard to establish appro-
priate safety, health, and environmental practices and deter-
5. Significance and Use
mine the applicability of regulatory limitations prior to use.
5.1 Harmful biological or particulate contaminants may
1.4 This international standard was developed in accor-
enter the package through imperfections such as pinholes or
dance with internationally recognized principles on standard-
cracks in trays.
ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
5.2 After initial instrument set-up and calibration, the op-
mendations issued by the World Trade Organization Technical
erations of individual tests and test results do not need operator
Barriers to Trade (TBT) Committee.
interpretation.
5.3 Leak test results that exceed the permissible threshold
2. Referenced Documents
setting are indicated by audible or visual signal responses, or
2.1 ASTM Standards:
both, or by other means.
D996 Terminology of Packaging and Distribution Environ-
5.4 This non-destructive test method may be performed in
ments
either laboratory or production environments and may be
F1327 Terminology Relating to Barrier Materials for Medi-
3 undertaken on either a 100 % or a statistical sampling basis.
cal Packaging (Withdrawn 2007)
This test method, in single instrument use and current
implementation, may not be fast enough to work on a produc-
3. Terminology
tion packaging line, but is well suited for statistical testing as
3.1 General Term Definitions—For definitions used in this
well as package developmental design work.
test method, see Terminologies D996 and F1327, Sections 3.
6. Apparatus
6.1 Non-destructive Trace Gas Leak Detection Apparatus—
This test method is under the jurisdiction ofASTM Committee F02 on Primary
Barrier Packaging and is the direct responsibility of Subcommittee F02.40 on
The apparatus’test fixture consists of three major elements and
Package Integrity.
is shown in Fig. 1.
Current edition approved Jan. 15, 2021. Published February 2021. Originally
approved in 2002. Last previous edition approved in 2013 as F2227 – 13. DOI:
6.2 Sealing Membrane—The purpose of the membrane is to
10.1520/F2227-13R21.
seal off the tracer gas transmission out of the top of the open
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
tray.
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
6.3 Control Trays—Calibrated pinholes, or leaks, con-
the ASTM website.
structedincontroltraysforinstrumentcalibrationaswellasfor
The last approved version of this historical standard is referenced on
www.astm.org. test procedure verification.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F2227 − 13 (2021)
FIG. 1 Schematic of Test Fixture and Test Tray
6.4 Test Fixture—Apparatus, which must be designed to expected that the calibration procedures be carried out fre-
ensure detection of a calibrated leak. quently; typically, at least one or more times a day, preferably
at the beginning of every shift.
7. Preparation of Apparatus
10.2 Refer to the instrument manufacturer’s operating in-
7.1 Thetestapparatusistobestarted,warmed-up,andmade
structionsregardingpreparationofCalibrationStandards,Con-
ready according to the manufacturer’s specifications. The
ditioning of Calibration Trays and Instrument Calibration used
instrument must be operated in an environment as described in
in establishing baseline settings.
the instrument’s user manual.
11. Procedure
8. Reagents and Materials
11.1 Verify that sufficient CO trace gas is available for the
8.1 CO Trace Gas Cylinder and Regulator—A cylinder of
tests. Monitor the trace gas supply and functionality of the gas
“Commercial” or “Bone Dry” grade carbon dioxide with a
delivery system.
minimum of 206.84-kPa (30-psi) pressure is required for
11.2 Select and implement the properly sized test fixture for
calibration and testing.
the trays to be tested. Verify that the instrument and associated
8.2 Sealing Membrane—The sealing membrane must ex-
test fixture have been calibrated for the trays to be tested. The
hibit the correct pliability and tackiness in order to form a
test fixture is too large when the instrument is unable to detect
gas-tight bond without leaving a residue on the tray-sealing
a calibrated control pinhole leak.
surface after removal from the test fixture.
11.3 Adjust the instrument baseline settings determined in
9. Hazards calibration.
9.1 As the test fixture is closed, it may present pinch-point
11.4 Place the tray to be tested into the test fixture making
hazards. certain that the tray is centered in the fixture and that good
sealing contact is made between the tray flange and the fixture
9.2 CO , although inert and non-toxic, can cause danger of
incorporated sealing.
suffocation if it is allowed to displace oxygen. Thus it is
NOTE 1—The sealing membrane needs to be clean in order to develop
recommendedthatthespentcarbondioxidebenaturallyvented
a good seal with the sealing flange of the tray. Laboratory conditions may
away from the test area and that adequate ventilation be
cause dust or debris to be collected on the sealing membrane. These
provided.
conditions thus will warrant frequent inspection and cleaning of the
sealing membrane with a lint-free cloth soaked with a solvent recom-
10. Calibration and Standardization mended by the manufacturer of the equipment.
10.1 Before any measurements are made, the apparatus 11.5 Close the top cover of the test fixture.
must be calibrated. The calibration procedure is used for
11.6 Start the test.
overall system checkout, as well as to establish an initial
11.7 Note the pass or fail indicator and record results. Set
reference profile for simulated pinhole leaks, and to determine
aside any “failed/defective” trays for further evaluation. Fur-
test limits for each different tray geometry to be tested using a
ther evaluation should include re-testing of the tray.
specific test fixture. The calibration procedure is perfo
...