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ASTM F2228-13(2021)

(Test Method)

Standard Test Method for Non-Destructive Detection of Leaks in Packaging Which Incorporates Porous Barrier Material by CO2 Tracer Gas Method

Standard Test Method for Non-Destructive Detection of Leaks in Packaging Which Incorporates Porous Barrier Material by CO<inf>2</inf> Tracer Gas Method

SIGNIFICANCE AND USE
5.1 Harmful biological or particulate contaminants may enter the package through incomplete seals or imperfections such as pinholes or cracks in the trays.  
5.2 After initial instrument set-up and calibration, the operations of individual tests and test results do not need operator interpretation. The non-destructive nature of the test may be important when testing high value added products.  
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. This testing 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 leaks in non-porous rigid thermoformed trays, as well as the seal between the porous lid and the tray. The test method detects channel leaks in packages as small as 100 μm (0.004 in.) diameter in the seal as well as 50 μm (0.002 in.) diameter pinholes, or equivalently sized cracks in the tray, subject to trace gas concentration in the package, package design and manufacturing tolerances.
Note 1: This test method does not claim to challenge the porous (breathable) lidding material. Any defects that may exist in the porous portion of the package will not be detected by this test method.  
1.2 The values stated in SI units are to be regarded as standard. The values given in parentheses after SI units are provided for information only and are not considered standard.  
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 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.

General Information

Status
Published
Publication Date
14-Jan-2021
ICS
11.020 - Medical sciences and health care facilities in general
19.100 - Non-destructive testing
Technical Committee
F02 - Primary Barrier Packaging
Drafting Committee
F02.40 - Package Integrity
Current Stage
Ref Project

Relations

Refers
ASTM F17-20 - Standard Terminology Relating to Primary Barrier Packaging
Effective Date
01-May-2020

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ASTM F2228-13(2021) - Standard Test Method for Non-Destructive Detection of Leaks in Packaging Which Incorporates Porous Barrier Material by CO<inf>2</inf> Tracer Gas MethodASTM F2228-13(2021) - Standard Test Method for Non-Destructive Detection of Leaks in Packaging Which Incorporates Porous Barrier Material by CO<inf>2</inf> Tracer Gas Method
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ASTM F2228-13(2021) - Standard Test Method for Non-Destructive Detection of Leaks in Packaging Which Incorporates Porous Barrier Material by CO<inf>2</inf> Tracer Gas Method
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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: F2228 − 13 (Reapproved 2021)
Standard Test Method for
Non-Destructive Detection of Leaks in Packaging Which
Incorporates Porous Barrier Material by CO Tracer Gas
2
1
Method
This standard is issued under the fixed designation F2228; 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 F17 Terminology Relating to Primary Barrier Packaging
F1327 Terminology Relating to Barrier Materials for Medi-
1.1 This non-destructive test method detects leaks in non-
3
cal Packaging (Withdrawn 2007)
porous rigid thermoformed trays, as well as the seal between
the porous lid and the tray. The test method detects channel
3. Terminology
leaksinpackagesassmallas100µm(0.004in.)diameterinthe
3.1 General Term Definitions—For definitions used in this
seal as well as 50 µm (0.002 in.) diameter pinholes, or
standard, see Terminologies D996, F17, and F1327.
equivalently sized cracks in the tray, subject to trace gas
concentration in the package, package design and manufactur-
3.2 Definitions of Terms Specific to This Standard:
ing tolerances.
3.2.1 basal flow, n—transverse transport of trace gas across
the seal due to gas flow within the plane of the porous barrier
NOTE 1—This test method does not claim to challenge the porous
(breathable) lidding material. Any defects that may exist in the porous material as well as flow between the porous barrier and the
portion of the package will not be detected by this test method.
temporary gasketing. This is an expected property of the
porous barrier material and does not represent a leak.
1.2 The values stated in SI units are to be regarded as
Experimentally, this flow may be thought of as noise, which
standard. The values given in parentheses after SI units are
willalwaysbepresent,tosomedegree,duringtestingandmust
provided for information only and are not considered standard.
be accounted for.
1.3 This standard does not purport to address all of the
3.2.2 trace gas, n—a compound selected solely for use to
safety concerns, if any, associated with its use. It is the
identify leakage flow.
responsibility of the user of this standard to establish appro-
priate safety, health, and environmental practices and deter-
4. Summary of Test Method
mine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accor-
4.1 This test method utilizes CO sensing techniques in the
2
dance with internationally recognized principles on standard-
detection of a CO trace gas to quantify leaks in medical
2
ization established in the Decision on Principles for the
packaging, which incorporates porous barrier material. This
Development of International Standards, Guides and Recom-
test method provides a qualitative (accept/reject) inspection
mendations issued by the World Trade Organization Technical
method to evaluate packages for pinhole, crack and channel
Barriers to Trade (TBT) Committee.
leaks. Further information on the “Leak Test Theory” may be
found in Annex A1.
2. Referenced Documents
2
2.1 ASTM Standards: 5. Significance and Use
D996 Terminology of Packaging and Distribution Environ-
5.1 Harmful biological or particulate contaminants may
ments
enter the package through incomplete seals or imperfections
such as pinholes or cracks in the trays.
1
This test method is under the jurisdiction ofASTM Committee F02 on Primary
5.2 After initial instrument set-up and calibration, the op-
Barrier Packaging and is the direct responsibility of Subcommittee F02.40 on
erations of individual tests and test results do not need operator
Package Integrity.
interpretation. The non-destructive nature of the test may be
Current edition approved Jan. 15, 2021. Published February 2021. Originally
approved in 2002. Last previous edition approved in 2013 as F2228 – 13. DOI:
important when testing high value added products.
10.1520/F2228-13R21.
2
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
3
Standards volume information, refer to the standard’s Document Summary page on The last approved version of this historical standard is referenced on
the ASTM website. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2228 − 13 (2021)
5.3 Leak test results that exceed the permissible thres
...

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1.2 The values stated in SI units are to be regarded as the standard. The 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 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.

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