ASTM F2227-13

Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Packaging Trays by CO₂ Tracer Gas Method

SIGNIFICANCE AND USE
5.1 Harmful biological or particulate contaminants may enter the package through imperfections such as pinholes or cracks in trays.  
5.2 After initial instrument set-up and calibration, the operations of individual tests and test results do not need operator interpretation.  
5.3 Leak test results that exceed the permissible threshold setting are indicated by audible or visual signal responses, or both, or by other means.  
5.4 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 μm (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

• Status: Historical
• Publication Date: 31-Jul-2013
• ICS: 11.020 - Medical sciences and health care facilities in general
• ICS: 19.100 - Non-destructive testing
• Technical Committee: F02 - Primary Barrier Packaging
• Drafting Committee: F02.40 - Package Integrity

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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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 − 13
Standard Test Method for
Non-Destructive Detection of Leaks in Non-sealed and
1
Empty Packaging Trays by CO Tracer Gas Method
2
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.
2
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-
3
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
2
tray.
detection of a CO trace gas to quantify leaks in medical
2
6.3 Control Trays—Calibrated pinholes, or leaks, con-
structedincontroltraysforinstrumentcalibrationaswellasfor
1
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 Aug. 1, 2013. Published September 2013. Originally
ensure detection of a calibrated leak.
approved in 2002. Last previous edition approved in 2007 as F2227 – 02 (2007).
DOI: 10.1520/F2227-13.
7. Preparation of Apparatus
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. 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.
3
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
1

---------------------- Page: 1 ----------------------
F2227 − 13
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
2
2
“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
delivery system.
calibra
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F2227 − 02 (Reapproved 2007) F2227 − 13
Standard Test Method for
Non-Destructive Detection of Leaks in Non-sealed and
1
Empty Medical Packaging Trays by CO Tracer Gas Method
2
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
1.1 This non-destructive test method detects pinhole leaks in trays, as small as 50 μm (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.
2. Referenced Documents
2
2.1 ASTM Standards:
D996 Terminology of Packaging and Distribution Environments
3
F1327 Terminology Relating to Barrier Materials for Medical Packaging (Withdrawn 2007)
3. Terminology
3.1 General Term Definitions—For definitions used in this test method, see Terminologies D996 and F1327, Sections 3.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 trace gas—a compound selected solely for use to identify leakage flow.
4. Summary of Test Method
4.1 This test method utilizes CO sensing techniques in the detection of a CO trace gas to quantify leaks in medical packaging
2 2
trays. The test method provides a qualitative (accept/reject) inspection method to evaluate trays for pinholes and cracks. Further
information on the “Leak Test Theory” may be found in Annex A1.
5. Significance and Use
5.1 Harmful biological or particulate contaminants may enter the package through imperfections such as pinholes or cracks in
trays.
5.2 After initial instrument set-up and calibration, the operations of individual tests and test results do not need operator
interpretation.
5.3 Leak test results that exceed the permissible threshold setting are indicated by audible or visual signal responses, or both,
or by other means.
5.4 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.
1
This test method is under the jurisdiction of ASTM Committee F02 on Flexible Barrier Packaging and is the direct responsibility of Subcommittee F02.40 on Package
Integrity.
Current edition approved April 1, 2007Aug. 1, 2013. Published May 2007September 2013. Originally approved in 2002. Last previous edition approved in 20022007 as
F2227 – 02.F2227 – 02 (2007). DOI: 10.1520/F2227-02R07.10.1520/F2227-13.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
The last approved version of this historical standard is referenced on www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2227 − 13
6. Apparatus
6.1 Non-destructive Trace Gas Leak Detection Apparatus—The apparatus’ test fixture consists of three major elements and is
shown in Fig. 1.
6.2 Sealing Membrane—The purpose of the membrane is to seal off the tracer gas transmission out of the top of the open tray.
6.3 Control Trays—Calibrated pinholes, or leaks, constructed in control trays for instrument calibration as well as for test
procedure verification.
6.4 Test Fixture—Apparatus, which must be designed to ensure detection of a calibrated leak.
7. Preparation of Apparatus
7.1 The test apparatus is to be started, warmed-up, and made ready according to the manufacturer’s specifications. The
instrument must be operated in an environment as described in the instrument’s user manual.
8. Reagents and Materials
8.1
...