ASTM F2227-02(2007)
(Test Method)Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Medical Packaging Trays by CO2 Tracer Gas Method
Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Medical Packaging Trays by CO<sub>2</sub> Tracer Gas Method
SIGNIFICANCE AND USE
Harmful biological or particulate contaminants may enter the package through imperfections such as pinholes or cracks in trays.
After initial instrument set-up and calibration, the operations of individual tests and test results do not need operator interpretation.
Leak test results that exceed the permissible threshold setting are indicated by audible or visual signal responses, or both, or by other means.
This non-destructive test method may be performed in either laboratory or production environments and may be undertaken on either a 100 % or a statistical sampling basis. This test method, in single instrument use and current implementation, may not be fast enough to work on a production packaging line, but is well suited for statistical testing as well as package developmental design work.
SCOPE
1.1 This non-destructive test method detects pinhole leaks in trays, as small as 50 m (0.002 in.) in diameter, or equivalently sized cracks, subject to trace gas concentration in the tray, tray design and manufacturing tolerances.
1.2 The values stated in SI units are to be regarded as standard units. Values in parentheses are for information only.
1.3 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)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F2227 − 02(Reapproved 2007)
Standard Test Method for
Non-Destructive Detection of Leaks in Non-sealed and
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Empty Medical Packaging Trays by CO Tracer Gas Method
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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 packaging trays. The test method provides a qualitative
(accept/reject) inspection method to evaluate trays for pinholes
1.1 This non-destructive test method detects pinhole leaks
and cracks. Further information on the “Leak Test Theory”
in trays, as small as 50 µm (0.002 in.) in diameter, or
may be found in Annex A1.
equivalently sized cracks, subject to trace gas concentration in
the tray, tray design and manufacturing tolerances.
5. Significance and Use
1.2 The values stated in SI units are to be regarded as
5.1 Harmful biological or particulate contaminants may
standard units. Values in parentheses are for information only.
enter the package through imperfections such as pinholes or
1.3 This standard does not purport to address all of the cracks in trays.
safety concerns, if any, associated with its use. It is the
5.2 After initial instrument set-up and calibration, the op-
responsibility of the user of this standard to establish appro-
erations of individual tests and test results do not need operator
priate safety and health practices and determine the applica-
interpretation.
bility of regulatory limitations prior to use.
5.3 Leak test results that exceed the permissible threshold
setting are indicated by audible or visual signal responses, or
2. Referenced Documents
both, or by other means.
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2.1 ASTM Standards:
5.4 This non-destructive test method may be performed in
D996 Terminology of Packaging and Distribution Environ-
either laboratory or production environments and may be
ments
undertaken on either a 100 % or a statistical sampling basis.
F1327 Terminology Relating to Barrier Materials for Medi-
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This test method, in single instrument use and current
cal Packaging (Withdrawn 2007)
implementation, may not be fast enough to work on a produc-
3. Terminology
tion packaging line, but is well suited for statistical testing as
well as package developmental design work.
3.1 General Term Definitions—For definitions used in this
test method, see Terminologies D996 and F1327, Sections 3.
6. Apparatus
3.2 Definitions of Terms Specific to This Standard:
6.1 Non-destructive Trace Gas Leak Detection Apparatus—
3.2.1 trace gas—a compound selected solely for use to
The apparatus’ test fixture consists of three major elements and
identify leakage flow.
is shown in Fig. 1.
4. Summary of Test Method 6.2 Sealing Membrane—The purpose of the membrane is to
seal off the tracer gas transmission out of the top of the open
4.1 This test method utilizes CO sensing techniques in the
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tray.
detection of a CO trace gas to quantify leaks in medical
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6.3 Control Trays—Calibrated pinholes, or leaks, con-
structedincontroltraysforinstrumentcalibrationaswellasfor
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This test method is under the jurisdiction ofASTM Committee F02 on Flexible
test procedure verification.
Barrier Packaging and is the direct responsibility of Subcommittee F02.40 on
Package Integrity.
6.4 Test Fixture—Apparatus, which must be designed to
Current edition approved April 1, 2007. Published May 2007. Originally
ensure detection of a calibrated leak.
approved in 2002. Last previous edition approved in 2002 as F2227 – 02. DOI:
10.1520/F2227-02R07.
7. Preparation of Apparatus
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For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
7.1 Thetestapparatusistobestarted,warmed-up,andmade
Standards volume information, refer to the standard’s Document Summary page on
ready according to the manufacturer’s specifications. The
the ASTM website.
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instrument must be operated in an environment as described in
The last approved version of this historical standard is referenced on
www.astm.org. the instrument’s user manual.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F2227 − 02 (2007)
FIG. 1 Schematic of Test Fixture and Test Tray
8. Reagents and Materials 11. Procedure
8.1 CO Trace Gas Cylinder and Regulator—A cylinder of 11.1 Verify that sufficient CO trace gas is available for the
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“Commercial” or “Bone Dry” grade carbon dioxide with a
tests. Monitor the trace gas supply and functionality of the gas
minimum of 206.84-kPa (30-psi) pressure is required for d
...
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