ASTM F3287-17
(Test Method)Standard Test Method for Nondestructive Detection of Leaks in Packages by Mass Extraction Method
Standard Test Method for Nondestructive Detection of Leaks in Packages by Mass Extraction Method
SIGNIFICANCE AND USE
5.1 Leaks in medical, pharmaceutical, or food product packages can affect product quality and consumer safety. Such leaks can arise from imperfections in package material or between mated components designed to seal the package. Defects can allow unwanted gas (e.g. oxygen or water vapor), particulates, liquids, or microbiological contaminants into or out of the package. Package defect detection can be a critical part of ensuring product quality and consumer safety. Use of a physical CCI test method for sterile products can be used to assure the stability of the package sterility property during transportation and product shelf life.
5.2 Mass extraction is a useful non-destructive test method for testing a wide variety of packages. Package shape and dimensions that can be tested using mass extraction are essentially unlimited, as long as a vacuum test chamber can be designed and manufactured to accommodate the package.
5.3 This method produces quantitative flow measurement results that are useful in comparing package sealing properties, different batches of product, material properties, and combinations of process parameters.
5.4 Applications for mass extraction range from manually loaded and operated machines to automatic unattended work cells. This method can be applied for audit testing or 100% in-line testing.
Note 2: Leak test methods that rely on gas or vapor transport, such as mass extraction, are not able to detect defects if they become plugged by solid or nonvolatile matter. Plugging is possible by exposure to environmental contaminants. In some cases, the packaged product itself can clog defects. For example, leak paths may become blocked by suspended solids, gelatinous matter or dried-out solutions. Product clogging propensity is a function of the product formulation, defect size and geometry, and may be linked to product storage and handling conditions as well as the time allotted to defect exposure. An investigation into the impact of repeate...
SCOPE
1.1 This method provides a nondestructive means to detect holes (leaks) in a variety of non-porous rigid and semi-rigid packages.
1.2 This test method detects package leaks by measuring the mass flow extracted from a package while the package is enclosed inside an evacuated test chamber. The test system is a closed system during the leakage measurement portion of the test cycle. The closed system includes a vacuum reservoir, Intelligent Molecular Flow Sensor (IMFS), and vacuum test chamber. Mass extracted from the test package into the vacuum test chamber flows to the vacuum reservoir through the IMFS to equalize the system. Mass flow rate from the vacuum chamber to the vacuum reservoir is measured by the IMFS. Based on the conservation of mass law, mass flow into the closed system is equal to the mass loss from the test package. The test system is capable of producing quantitative (variable data) or quantitative (pass/fail) results depending on the requirements.
1.2.1 Headspace gas leakage defects equivalent to a 1µm diameter glass micropipette (sharp edge defect) can be detected at a 95% confidence level.
1.2.2 Liquid leakage defects equivalent to a 1µm diameter glass micropipette can be detected at a 95% confidence level for glass vials and LDPE bottles. Liquid leakage defects equivalent to a 2µm diameter glass micropipette can be detected for glass syringes.
1.3 Units—The values stated in SI units are to be regarded as standard. Pressure units are expressed as Pa, mbar, or Torr.
1.4 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.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization esta...
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Designation: F3287 − 17
Standard Test Method for
Nondestructive Detection of Leaks in Packages by Mass
1,2
Extraction Method
This standard is issued under the fixed designation F3287; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope priate safety, health, and environmental practices and deter-
mine the applicability of regulatory limitations prior to use.
1.1 This method provides a nondestructive means to detect
1.5 This international standard was developed in accor-
holes (leaks) in a variety of non-porous rigid and semi-rigid
dance with internationally recognized principles on standard-
packages.
ization established in the Decision on Principles for the
1.2 Thistestmethoddetectspackageleaksbymeasuringthe
Development of International Standards, Guides and Recom-
mass flow extracted from a package while the package is
mendations issued by the World Trade Organization Technical
enclosed inside an evacuated test chamber. The test system is
Barriers to Trade (TBT) Committee.
aclosedsystemduringtheleakagemeasurementportionofthe
test cycle. The closed system includes a vacuum reservoir,
2. Referenced Documents
Intelligent Molecular Flow Sensor (IMFS), and vacuum test
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2.1 ASTM Standards:
chamber.Massextractedfromthetestpackageintothevacuum
E177Practice for Use of the Terms Precision and Bias in
test chamber flows to the vacuum reservoir through the IMFS
ASTM Test Methods
to equalize the system. Mass flow rate from the vacuum
E691Practice for Conducting an Interlaboratory Study to
chamber to the vacuum reservoir is measured by the IMFS.
Determine the Precision of a Test Method
Based on the conservation of mass law, mass flow into the
F17Terminology Relating to Primary Barrier Packaging
closed system is equal to the mass loss from the test package.
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2.2 ISO Standard:
The test system is capable of producing quantitative (variable
ISO/IEC 17025General requirements for the competence of
data) or quantitative (pass/fail) results depending on the
testing and calibration laboratories
requirements.
1.2.1 Headspace gas leakage defects equivalent to a 1µm
3. Terminology
diameterglassmicropipette(sharpedgedefect)canbedetected
3.1 For terminology related to flexible barrier packaging,
at a 95% confidence level.
see Terminology F17.
1.2.2 Liquid leakage defects equivalent to a 1µm diameter
glass micropipette can be detected at a 95% confidence level
3.2 Definitions of Terms Specific to This Standard:
for glass vials and LDPE bottles. Liquid leakage defects
3.2.1 baseline flow measurement, n—measuredflowratefor
equivalent to a 2µm diameter glass micropipette can be
a negative control test package. Measured flow is largely
detected for glass syringes.
attributed to characteristics of the package (material type,
labels, etc.).
1.3 Units—The values stated in SI units are to be regarded
as standard. Pressure units are expressed as Pa, mbar, or Torr. 3.2.2 blank master part, n—a piece of metal tooling with
similar volume and shape as the actual test package. This is
1.4 This standard does not purport to address all of the
used to represent a leak free package.
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro- 3.2.3 chamber base, n—lower portion of a vacuum test
chamber that is connected to the mass extraction test instru-
ment. Chamber base commonly includes an o-ring to seal the
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ThistestmethodisunderthejurisdictionofASTMCommitteeF02onPrimary
chamber lid onto the base. The chamber base also contains a
Barrier Packaging and is the direct responsibility of Subcommittee F02.40 on
Package Integrity.
Current edition approved Nov. 1, 2017. Published November 2017. DOI:
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10.1520/F3287-17. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
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