ASTM F2228-02
(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
SCOPE
DESIG: F2228 02 ^TITLE: Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which Incorporates Porous Barrier Material by CO2 Tracer Gas Method ^SCOPE:1. 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.
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.
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Designation:F2228–02
Standard Test Method for
Non-Destructive Detection of Leaks in Medical Packaging
Which Incorporates Porous Barrier Material by CO Tracer
Gas Method
This standard is issued under the fixed designation F 2228; 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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope 3.2 Definitions of Terms Specific to This Standard:
3.2.1 basal flow—transverse transport of trace gas across
1.1 This non-destructive test method detects leaks in non-
the seal due to gas flow within the plane of the porous barrier
porous rigid thermoformed trays, as well as the seal between
material as well as flow between the porous barrier and the
the porous lid and the tray. The test method detects channel
temporary gasketing. This is an expected property of the
leaksinpackagesassmallas100µm(0.004in.)diameterinthe
porous barrier material and does not represent a leak. Experi-
seal as well as 50 µm (0.002 in.) diameter pinholes, or
mentally, this flow may be thought of as noise, which will
equivalently sized cracks in the tray, subject to trace gas
always be present, to some degree, during testing and must be
concentration in the package, package design and manufactur-
accounted for.
ing tolerances.
3.2.2 trace gas—a compound selected solely for use to
NOTE 1—This test method does not claim to challenge the porous
identify leakage flow.
(breathable) lidding material. Any defects that may exist in the porous
portion of the package will not be detected by this test method.
4. Summary of Test Method
1.2 The values stated in SI units are to be regarded as
4.1 This test method utilizes CO sensing techniques in the
standard units. Values in parentheses are for information only.
detection of a CO trace gas to quantify leaks in medical
1.3 This standard does not purport to address all of the
packaging, which incorporates porous barrier material. This
safety concerns, if any, associated with its use. It is the
test method provides a qualitative (accept/reject) inspection
responsibility of the user of this standard to establish appro-
method to evaluate packages for pinhole, crack and channel
priate safety and health practices and determine the applica-
leaks. Further information on the “Leak Test Theory” may be
bility of regulatory limitations prior to use.
found in Annex A1.
2. Referenced Documents
5. Significance and Use
2.1 ASTM Standards:
5.1 Harmful biological or particulate contaminants may
D 996 Terminology of Packaging and Distribution Environ-
enter the package through incomplete seals or imperfections
ments
such as pinholes or cracks in the trays.
F17 Terminology Relating to Flexible Barrier Materials
5.2 After initial instrument set-up and calibration, the op-
F 1327 TerminologyRelatingtoBarrierMaterialsforMedi-
erations of individual tests and test results do not need operator
cal Packaging
interpretation. The non-destructive nature of the test may be
important when testing high value added products.
3. Terminology
5.3 Leak test results that exceed the permissible threshold
3.1 General Term Definitions—For definitions used in this
setting are indicated by audible or visual signal responses, or
standard, see Terminologies D 996, F 17, and F 1327.
both, or by other means.
5.4 This non-destructive test method may be performed in
either laboratory or production environments. This testing may
This test method is under the jurisdiction ofASTM Committee F02 on Flexible
be undertaken on either a 100 % or a statistical sampling basis.
Barrier Materials and is the direct responsibility of Subcommittee F02.40 on
Package Integrity. This test method, in single instrument use and current imple-
Current edition approved Dec. 10, 2002. Published February 2003.
mentation, may not be fast enough to work on a production
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
packaging line, but is well suited for statistical testing as well
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
as package developmental design work.
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F2228–02
6. Apparatus 8.3 Sealing Membrane-induced Damage—During the pro-
cess of membrane selection for a specific package design and
6.1 Non-destructive Trace Gas Leak Detection Apparatus—
configuration, inspect the packages for the following indica-
The apparatus’ test fixture consists of three major elements and
tions of membrane-induced damage after the membrane is
is shown in Fig. 1.
removed from the package:
6.2 Sealing Membrane—The purpose of the sealing mem-
8.3.1 Sticky residue remaining on the porous barrier mate-
brane is to seal off the tracer gas transmission, normal to the
rial at the end of the test cycle.
porous lid surface. However, the membrane does not com-
8.3.2 Fibers from the porous barrier material remaining on
pletely control the transmission of tracer gas basal flow in the
the sealing membrane at the end of the test cycle.
transverse direction.
8.3.3 Visible changes to the texture or structure of the
6.3 Control Packages—Packages with calibrated capillary
porous lidding material at the end of the test cycle, under
channel leaks as well as packages with calibrated pinholes in
microscope or other magnified examination.
the tray constructed for instrument calibration as well as for
8.3.4 Damage to the printed information on the porous
test procedure verification.
barrier. The adhesive of the sealing membrane may lift off the
6.4 Test Fixture—Apparatus, which must be designed to
ink from the barrier.
ensure detection of a calibrated leak.
8.3.5 Failure of the package to release from the sealing
membrane at the end of the test cycle.
7. Preparation of Apparatus
8.3.6 Damage to the seal incurred on removal of the
7.1 Thetestapparatusistobestarted,warmed-up,andmade
membrane from the package.
ready according to the manufacturer’s specifications. The
instrument must be operated in an environment as described in
9. Hazards
the instrument’s user manual.
9.1 As the test fixture is closed, it may present pinch-point
8. Reagents and Materials hazards.
9.2 CO , although inert and non-toxic, can cause danger of
8.1 CO Trace Gas Cylinder and Regulator—A cylinder of 2
suffocation if it is allowed to displace oxygen. Thus it is
“Commercial” or “Bone Dry” grade carbon dioxide with a
recommendedthatthespentcarbondioxidebenaturallyvented
minimum of 206.84 kPa (30 psi) pressure is required for
away from the test area and that adequate ventilation be
calibration and testing.
provided.
8.2 Sealing Membrane—The temporary sealing membrane
must exhibit the correct pliability and tackiness in order to
10. Calibration and Standardization
form a gas-tight bond with the porous lidding materials during
the testing process, and must release at the end of the test 10.1 Before any measurements are made, the apparatus
without damaging the porous lid or the edge seal. must be calibrated. The calibration procedure is used for
FIG. 1 Schematic of Test Fixture and Test Package
F2228–02
overall system checkout, as well as to establish an initial 12.1.7 Record the failed packages to be rejected by identi-
referenceprofileforasimulatedchannelorpinholeleak,andto fying either individual serial numbers or lot numbers.
determine test limits for each different package geometry that 12.1.8 Record the disposition of good packages as well as
is to be tested using a specific test fixture. The calibration failed packages.
procedureisperformedtoestablishthesensitivitysettingofthe 12.1.9 Copies of any software-generated data sheets, or
instrumentation. It is expected that the calibration procedures reports produced during the testing.
are carried out frequently; typically, at least one or more times
13. Precision and Bias
a day, preferably at the beginning of every shift.
10.2 Refer to the instrument manufacturer’s operating in- 13.1 Precision—A round robin study was conducted in
2002, which included three laboratories. Packages with and
structionsregardingpreparationofCalibrationStandards,Con-
ditioning of Calibration Packages and Instrument Calibration without channels in the seal area and pinholes in the trays were
tested for leaks. The equipment used in this interlaboratory
used in establishing baseline settings.
study was the Pac Guard Model 500 available from MOCON.
13.1.1 Two different package sizes were tested. The larger
11. Procedure
package consisting of a PETE tray and an adhesive coated
11.1 Verify that sufficient CO trace gas is available for the
1073B Tyvek lidding had the approximate outside dimensions
tests. Check the trace gas supply and functionality of the gas
of 129 mm wide by 167 mm long by 20 mm high (5.1 by 6.6
delivery system.
by 0.8 in.) with an internal volume of 208 mL. The smaller
11.2 Select and implement
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