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
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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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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: F2228 − 02(Reapproved 2007)
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 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-
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
2.1 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-
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
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
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.
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
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—The temporary sealing membrane
as package developmental design work.
must exhibit the correct pliability and tackiness in order to
form a gas-tight bond with the porous lidding materials during
6. Apparatus
the testing process, and must release at the end of the test
6.1 Non-destructive Trace Gas Leak Detection Apparatus
without damaging the porous lid or the edge seal.
—The apparatus’ test fixture consists of three major elements
8.3 Sealing Membrane-induced Damage— During the pro-
and is shown in Fig. 1.
cess of membrane selection for a specific package design and
6.2 Sealing Membrane—The purpose of the sealing mem-
configuration, inspect the packages for the following indica-
brane is to seal off the tracer gas transmission, normal to the
tions of membrane-induced damage after the membrane is
porous lid surface. However, the membrane does not com-
removed from the package:
pletely control the transmission of tracer gas basal flow in the
8.3.1 Sticky residue remaining on the porous barrier mate-
transverse direction.
rial at the end of the test cycle.
6.3 Control Packages—Packages with calibrated capillary
8.3.2 Fibers from the porous barrier material remaining on
channel leaks as well as packages with calibrated pinholes in
the sealing membrane at the end of the test cycle.
the tray constructed for instrument calibration as well as for
8.3.3 Visible changes to the texture or structure of the
test procedure verification.
porous lidding material at the end of the test cycle, under
microscope or other magnified examination.
6.4 Test Fixture—Apparatus, which must be designed to
8.3.4 Damage to the printed information on the porous
ensure detection of a calibrated leak.
barrier. The adhesive of the sealing membrane may lift off the
7. Preparation of Apparatus ink from the barrier.
8.3.5 Failure of the package to release from the sealing
7.1 Thetestapparatusistobestarted,warmed-up,andmade
membrane at the end of the test cycle.
ready according to the manufacturer’s specifications. The
8.3.6 Damage to the seal incurred on removal of the
instrument must be operated in an environment as described in
membrane from the package.
the instrument’s user manual.
9. Hazards
8. Reagents and Materials
8.1 CO Trace Gas Cylinder and Regulator —Acylinder of 9.1 As the test fixture is closed, it may present pinch-point
“Commercial” or “Bone Dry” grade carbon dioxide with a hazards.
FIG. 1 Schematic of Test Fixture and Test Package
F2228 − 02 (2007)
9.2 CO , although inert and non-toxic, can cause danger of 12.1.2 The serial numbers, calibration values and most
suffocation if it is allowed to displace oxygen. Thus it is recent calibration dates for all calibration standards used.
recommendedthatthespentcarbondioxidebenaturallyvented 12.1.3 Record the date, time, location, and identification of
away from the test area and that adequate ventilation be the apparatus and the operator.
provided. 12.1.4 Record the package type, size, material, product, and
traceable identification numbers.
10. Calibration and Standardization
12.1.5 Record the leak rate reject set point as programmed
10.1 Before any measurements are made, the apparatus into the apparatus.
12.1.6 Record the number of packages tested, and the
must be calibrated. The calibration procedure is used for
overall system checkout, as well as to establish an initial number of failed packages.
12.1.7 Record the failed packages to be rejected by identi-
referenceprofileforasimulatedchannelorpinholeleak,andto
determine test limits for each different package geometry that fying either individual serial numbers or lot numbers.
12.1.8 Record the disposition of good packages as well as
is to be tested using a specific test fixture. The calibration
procedureisperformedtoestablishthesensitivitysettingofthe failed packages.
instrumentation. It is expected that the calibration procedures 12.1.9 Copies of any software-generated data sheets, or
reports produced during the testing.
are carried out frequently; typically, at least one or more times
a day, preferably at the beginning of every shift.
13. Precision and Bias
10.2 Refer to the instrument manufacturer’s operating in-
13.1 Precision—A round robin study was conducted in
structionsregardingpreparationofCalibrationStandards,Con-
2002, which included three laboratories. Packages with and
ditioning of Calibration Packages and Instrument Calibration
without channels in the seal area and pinholes in the trays were
used in establishing baseline settings.
tested for leaks. The equipment used in this in
...
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