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ASTM F2228-02(2007)

(Test Method)

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

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

SIGNIFICANCE AND USE
Harmful biological or particulate contaminants may enter the package through incomplete seals or imperfections such as pinholes or cracks in the trays.  
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.
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. 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 m (0.004 in.) diameter in the seal as well as 50 m (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 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-Mar-2007
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

Replaces
ASTM F2228-02 - Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which Incorporates Porous Barrier Material by CO<sub>2</sub> Tracer Gas Method
Effective Date
01-Apr-2007
Referred By
ASTM F2097-20 - Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
Effective Date
01-Apr-2007

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ASTM F2228-02(2007) - Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which Incorporates Porous Barrier Material by CO<sub>2</sub> Tracer Gas MethodASTM F2228-02(2007) - Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which Incorporates Porous Barrier Material by CO<sub>2</sub> Tracer Gas Method
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ASTM F2228-02(2007) - Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which Incorporates Porous Barrier Material by CO<sub>2</sub> Tracer Gas Method
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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: F2228 − 02(Reapproved 2007)
Standard Test Method for
Non-Destructive Detection of Leaks in Medical Packaging
Which Incorporates Porous Barrier Material by CO Tracer
2
1
Gas 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 3. Terminology
3.1 General Term Definitions—For definitions used in this
1.1 This non-destructive test method detects leaks in non-
standard, see Terminologies D996, F17, and F1327.
porous rigid thermoformed trays, as well as the seal between
the porous lid and the tray. The test method detects channel
3.2 Definitions of Terms Specific to This Standard:
leaksinpackagesassmallas100µm(0.004in.)diameterinthe
3.2.1 basal flow—transversetransportoftracegasacrossthe
seal as well as 50 µm (0.002 in.) diameter pinholes, or
seal due to gas flow within the plane of the porous barrier
equivalently sized cracks in the tray, subject to trace gas
material as well as flow between the porous barrier and the
concentration in the package, package design and manufactur-
temporary gasketing. This is an expected property of the
ing tolerances.
porous barrier material and does not represent a leak.
Experimentally, this flow may be thought of as noise, which
NOTE 1—This test method does not claim to challenge the porous
willalwaysbepresent,tosomedegree,duringtestingandmust
(breathable) lidding material. Any defects that may exist in the porous
be accounted for.
portion of the package will not be detected by this test method.
3.2.2 trace gas—a compound selected solely for use to
1.2 The values stated in SI units are to be regarded as
identify leakage flow.
standard units. Values in parentheses are for information only.
1.3 This standard does not purport to address all of the
4. Summary of Test Method
safety concerns, if any, associated with its use. It is the
4.1 This test method utilizes CO sensing techniques in the
responsibility of the user of this standard to establish appro-
2
detection of a CO trace gas to quantify leaks in medical
priate safety and health practices and determine the applica- 2
packaging, which incorporates porous barrier material. This
bility of regulatory limitations prior to use.
test method provides a qualitative (accept/reject) inspection
method to evaluate packages for pinhole, crack and channel
2. Referenced Documents
leaks. Further information on the “Leak Test Theory” may be
2
2.1 ASTM Standards:
found in Annex A1.
D996 Terminology of Packaging and Distribution Environ-
ments
5. Significance and Use
F17 Terminology Relating to Flexible Barrier Packaging
5.1 Harmful biological or particulate contaminants may
F1327 Terminology Relating to Barrier Materials for Medi-
3
enter the package through incomplete seals or imperfections
cal Packaging (Withdrawn 2007)
such as pinholes or cracks in the trays.
5.2 After initial instrument set-up and calibration, the op-
erations of individual tests and test results do not need operator
1
This test method is under the jurisdiction ofASTM Committee F02 on Flexible
Barrier Packaging and is the direct responsibility of Subcommittee F02.40 on interpretation. The non-destructive nature of the test may be
Package Integrity.
important when testing high value added products.
Current edition approved April 1, 2007. Published May 2007. Originally
approved in 2002. Last previous edition approved in 2002 as F2228 – 02. DOI:
5.3 Leak test results that exceed the permissible threshold
10.1520/F2228-02R07.
setting are indicated by audible or visual signal responses, or
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
both, or by other means.
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
5.4 This non-destructive test method may be performed in
the ASTM website.
3
either laboratory or production environments. This testing may
The last approved version of this historical standard is referenced on
www.astm.org. be undertaken on either a 100 % or a statistical sampling basis.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2228 − 02 (2007)
This test method, in single instrument use and current imple- minimum of 206.84 kPa (30 psi) pressure is required for
mentation, may not be fast enough to work on a production calibration and testing.
packaging line, but is well suited for statistical testing as well
8.2 Sealing Membrane—Th
...

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5.1 Harmful biological or particulate contaminants may enter the package through incomplete seals or imperfections such as pinholes or cracks in the trays.  
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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.  
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