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: F2338 − 09 (Reapproved 2020)

Standard Test Method for

Nondestructive Detection of Leaks in Packages by Vacuum
Decay Method1
This standard is issued under the fixed designation F2338; 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 adhesive bonding defects can also be detected. All porous

1.1 Test Packages—Packages that can be nondestructively barrier lidding material packages were tested at a Target
evaluated by this test method include: Vacuum of –4·E4 Pa (–400 mbar). The sensitivity of the test for
1.1.1 Rigid and semi-rigid non-lidded trays. porous lidded packages is approximately E-2 Pa·m3·s-1 using a
1.1.2 Trays or cups sealed with porous barrier lidding calibrated volumetric airflow meter.
material. 1.2.3 Rigid, Nonporous Packages (Headspace Gas
1.1.3 Rigid, nonporous packages. Leakage)—Hole defects of at least 5 µm in diameter can be
1.1.4 Flexible, nonporous packages. detected. Plastic bottles with screw caps were tested at a target
1.2 Leaks Detected—This test method detects package leaks vacuum of –5·E4 Pa (–500 mbar). Using a calibrated volumet-
by measuring the rise in pressure (vacuum loss) in an enclosed ric airflow meter, the sensitivity of the test is approximately
evacuated test chamber containing the test package. Vacuum E-3.4 Pa·m3·s-1. Air-filled glass syringes were tested at a target
vacuum of –7.5·E4 Pa (+250 mbar absolute) and again at a
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loss results from leakage of test package headspace gases
and/or volatilization of test package liquid contents located in target vacuum of about +1 mbar absolute. The sensitivity of
or near the leak. When testing for leaks that may be partially or both tests is approximately E-4.1 Pa·m3·s-1 using a calibrated

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completely plugged with the package’s liquid contents, the test
chamber is evacuated to a pressure below the liquid’s vapor-
volumetric airflow meter.
1.2.4 Rigid, Nonporous Packages (Liquid Leakage)—Hole

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ization pressure. All methods require a test chamber to contain
the test package and a leak detection system designed with one
or more pressure transducers. Test method sensitivities cited
defects of at least 5 µm in diameter can be detected. This
detection limit was verified using a population of water-filled
glass syringes tested at a target vacuum of about +1 mbar
below were determined using specific product-package sys- absolute.
tems selected for the precision and bias studies ASTM F2338-09(2020)
summarized in 1.2.5 Flexible, Nonporous Packages (Gas or Liquid
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Table 1. Table 1 also lists other examples of relevant product- Leakage)—Such packages may also be tested by the vacuum
package systems that can be tested for leakage by vacuum decay method. Sensitivity data for flexible packages were not
decay. included in the precision and bias studies, although the use of
1.2.1 Trays or Cups (Non-lidded) (Air Leakage)—Hole or
vacuum decay for testing such packages is well known.
crack defects in the wall of the tray/cup of at least 50 µm in
diameter can be detected. Nonlidded trays were tested at a 1.3 Test Results—Test results are qualitative (Accept/
Target Vacuum of –4·E4 Pa (–400 mbar). Reject). Acceptance criteria are established by comparing
1.2.2 Trays Sealed with Porous Barrier Lidding Material quantitative baseline vacuum decay measurements obtained
(Headspace Gas Leakage)—Hole or crack defects in the wall from control, non-leaking packages to measurements obtained
of the tray/cup of at least 100 µm in diameter can be detected. using leaking packages, and to measurements obtained with the
Channel defects in the seal area (made using wires of 125 µm introduction of simulated leaks using a calibrated gas flow
in diameter) can be detected. Severe seal bonding defects in meter.
both continuous adhesive and dot matrix adhesive package
systems can be detected. Slightly incomplete dot matrix 1.4 The values stated in SI units are to be regarded as
standard. No other units of measurement are included in this
standard.
1
This test method is under the jurisdiction of ASTM Committee F02 on Primary 1.5 This standard does not purport to address all of the
Barrier Packaging and is the direct responsibility of Subcommittee F02.40 on safety concerns, if any, associated with its use. It is the
Package Integrity. responsibility of the user of this standard to establish appro-
Current edition approved Nov. 15, 2020. Published December 2020. Originally
approved in 2003. Last previous edition approved in 2013 as F2338 – 09 (2013). priate safety, health, and environmental practices and deter-
DOI: 10.1520/F2338-09R20. mine the applicability of regulatory limitations prior to use.

Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States

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 F2338 − 09 (2020)
TABLE 1 Summary of Vacuum Decay Leak Tests Applications for Various Product-Packages Systems
Package ExamplesA Package Content Examples ASTM P&B Data Tables Target VacuumB
GAS LEAK TEST
PACKAGE APPLICATIONS AND PRECISION & BIAS STUDIES
Porous barrier lidded traysC Empty 3, 4, 5 –400 mbar
Solids (tablets, capsules, powders, devices)
C
Nonlidded trays or cups Empty 2 –400 mbar
Plastic screw capped bottlesC Solids (tablets, capsules, powders) 6 –500 mbar
Liquids (with significant gas headspace volume)
Glass syringesC Solids (lyophilized powders) 7, 8 +250 mbar

ADDITIONAL GAS LEAK TEST PACKAGE APPLICATIONSA

Lidded (nonporous) trays or cups containing solid materials (for example, powders, tablets, capsules, devices)
Glass or plastic vials closed with elastomeric closures containing solid materials (for example, powders)
Glass or plastic vials closed with elastomeric closures, containing liquid materials, but with significant gas headspace volume
Flexible packages (for example pouches or bags) containing solid materials (for example, powders, devices)
LIQUID LEAK TEST (with or without gas headspace)
PACKAGE APPLICATIONS AND PRECISION & BIAS STUDIES
Glass syringesC Liquids 9, 10 +1 mbar

A
ADDITIONAL LIQUID LEAK TEST PACKAGE APPLICATIONS
Ophthalmic dropper tip bottles containing liquid materials
Glass or plastic ampoules containing liquid materials
Glass or plastic vials with elastomeric closures containing liquid materials
Lidded (nonporous trays or cups) containing liquid materials
Flexible packages such as pouches or bags containing liquid materials
A
Examples of package types relevant to the specified leak test method are listed. The list is not intended to be all inclusive.
B
Target vacuum expressed as a negative mbar reading (for example, –400 mbar) refers to the measured test chamber pressure (vacuum) relative to atmospheric pressure.
Target vacuum expressed as a positive mbar reading (for example, +1 mbar) refers to the absolute pressure reading in the test chamber.
C
Packages used for the referenced ASTM Precision and Bias (P&B) studies.

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1.6 This international standard was developed in accor- 3.2.2 control, non-leaking packages, n—packages without
dance with internationally recognized principles on standard- defects and properly sealed or closed according to manufac-
ization established in the Decision on Principles for the turer’s specifications.

mendations issued by the World TradeDocument

Organization Technical Preview
Development of International Standards, Guides and Recom- 3.2.3 flexible, nonporous packages, n—packages that sig-
nificantly deflect when under vacuum, and are constructed of
Barriers to Trade (TBT) Committee. malleable, nonporous materials. Examples include pouches or
2. Referenced Documents
ASTM F2338-09(2020)
bags made of polymeric, foil, or laminate films.
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2.1 ASTM Standards:2
3.2.4 gas leaks, n—leak paths that allow the flow of gas
from the test package.
D996 Terminology of Packaging and Distribution Environ-
3.2.5 liquid leaks, n—leak paths partially or fully filled with
ments
liquid.
E691 Practice for Conducting an Interlaboratory Study to
Determine the Precision of a Test Method 3.2.6 rigid, nonporous packages, n—packages that do not
F17 Terminology Relating to Primary Barrier Packaging significantly deflect under vacuum and are constructed of solid,
F1327 Terminology Relating to Barrier Materials for Medi- nonporous materials. Examples include plastic bottles with
cal Packaging (Withdrawn 2007)3 screw-thread or snap-on closures, glass or plastic vials with
elastomeric closures, and glass or plastic syringes.
3. Terminology 3.2.7 semi-rigid trays or cups, n—trays made of material
3.1 Definitions—For definitions used in this test method, see that retain shape upon deflection. For example, thermoformed
Terminologies D996, F17, and F1327. PETE or PETG trays are considered semi-rigid trays.
3.2 Definitions of Terms Specific to This Standard: 3.2.8 spotty or mottled seals, n—an incomplete adhesive
3.2.1 baseline vacuum decay, n—the extent of vacuum bond made between a package tray or cup and porous lidding
change within the test chamber over time demonstrated by a material that can be visibly identified by a distinctive pattern of
control, non-leaking package. dots, spotting or mottling on the tray sealing surface after the
lid is removed.
3.2.9 volumetric airflow meter, n—a calibration tool that can
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or be used to provide an artificial leak of known volumetric
contact ASTM Customer Service at [email protected]. For Annual Book of ASTM airflow rate into the test chamber for verification of instrument
Standards volume information, refer to the standard’s Document Summary page on
sensitivity. Airflow meters should be calibrated to NIST
the ASTM website.
3
The last approved version of this historical standard is referenced on standards. The operational range of the meter should reflect the
www.astm.org. desired limit of sensitivity for the intended leak test.

2
 F2338 − 09 (2020)
3.3 Definitions of Test Cycle and Critical Parameters 5. Significance and Use
Terms—For terms and abbreviations relating to the test cycle 5.1 Leaks in medical device, pharmaceutical, and food
and the critical parameters for establishing accept/reject limits, packages may result in the ingress of unwanted gases (most
see Annex A1. commonly oxygen), harmful microbiological, or particulate
contaminants. Package leaks may appear as imperfections in
4. Summary of Test Method the package components themselves or at the seal juncture
4.1 The test package is placed in a test chamber to which between mated components. The ability to detect leaks is
vacuum is applied. The chamber is then isolated from the necessary to ensure consistency and integrity of packages.
vacuum source and a pressure transducer (absolute or gauge) 5.2 After initial set-up and calibration, individual test op-
alone or in combination with a second differential pressure eration may be semi-automatic, automatic, or manual. The test
transducer, is used to monitor the test chamber for both the method permits non-destructive detection of leaks not visibly
level of vacuum, as well as the change in vacuum over time. detectable. The test method does not require the introduction of
Vacuum decay, or rise in chamber pressure, is a result of any extraneous materials or substances, such as dyes or gases.
package headspace gas being drawn out of the package through However, it is important to physically mask or block off any
any leaks present, plus background noise. Vacuum decay can package porous barrier surface during the test to prevent rapid
also result from the volatilization of packaged liquid that loss of chamber vacuum resulting primarily from gas migration
partially or fully occludes the leak path. In this case, vacuum through the porous surface. Leak detection is based solely on
decay will only occur if the chamber test pressure is lowered the ability to detect the change in pressure inside the test
below the liquid’s vaporization pressure. chamber resulting from gas or vapor egress from a package
challenged with vacuum.
4.2 Porous barrier lidded tray or cup packages are tested for
leaks located in the tray or cup, and at the lidding material/tray 5.3 This test is a useful research tool for optimizing package
seal junction. Leaks in the porous lidding material itself cannot sealing parameters and for comparatively evaluating various
packages and materials. This test method is also applicable to
be detected. When testing such packages, steps are taken to
production settings as it is rapid, non-invasive, and non-
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physically mask or block the porous barrier surface to prevent
destructive, making it useful for either 100 % on-line testing or
the migration of package gas through the porous lid. These
to perform tests on a statistical sampling from the production
steps may require some sample preparation, depending on the
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masking approach required, but must be nondestructive and
operation.
5.4 Leak test results that exceed the permissible limits for
noninvasive. Vacuum decay from porous barrier lidded pack-

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the vacuum decay test are indicated by audible or visual signal
ages may potentially include background noise from gas
responses, or both.
trapped between the lidding material and the masking surface,
or from transverse gas flow through the porous barrier material 6. Apparatus
itself at the lid/tray seal junction.
ASTM F2338-09(2020) 6.1 Vacuum Decay Leak Detection Apparatus—The vacuum
4.3 The sensitivity of a test is a function of test package decay leak apparatus includes a test chamber connected to a
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design, transducer(s)’sensitivity, test chamber design, test sys- vacuum decay test system and a volumetric airflow meter.
tem design, and critical test parameters of time and pressure.
6.2 Test Chamber—The test chamber has a lower compart-
The test system and leak test parameters selected for any given ment (lower tooling) designed to nest the test package, and an
product-package system must be based on the package’s upper lid (top tooling) for closing the test chamber. Fig. 1
contents (liquid or solid with significant or little gas illustrates a test chamber designed for testing packages with
headspace), and the nature of the package (flexible or rigid, porous barrier lidding material. The test fixture upper lid
porous or nonporous). Instruments with more sensitive pres- consists of a flexible bladder to mask the package’s porous
sure transducers and with minimal void volumes within the test barrier during the test cycle. Figs. 2 and 3 illustrate test
chamber and the test system have the potential to detect the chambers designed for testing rigid, nonporous packages. In
smallest leaks. Lengthening test time enables smaller gaseous the latter two cases, there is no flexible bladder.
leaks to be detected. Minimizing pressure variation back- 6.2.1 Tray Nest or Lower Tooling—The bottom half of the
ground noise can also improve test sensitivity. For porous test chamber is dimensionally designed to closely nest the test
barrier lidded packages, masking techniques will minimize package, while still allowing for easy gas flow around the test
background noise. For flexible or semi-rigid packages, restrict- package. Without ready gas flow around the package, leakage
ing package expansion via properly designed test chambers sites can be blocked. Conversely, the larger the gap between
lessens noise. Background noise may also occur upon release the test chamber and the test package, the less sensitive the leak
of residual gases or vapors trapped in the test system or test, as vacuum decay from package leakage will be minimized
between test package components. Such noise can be differen- in a larger net test chamber volume.
tiated from actual leakage by lengthening the time to reach 6.2.2 Upper Lid or Upper Tooling—The upper lid is de-
initial vacuum or lengthening equalization time. signed to tightly seal the closed test chamber during the
NOTE 1—Further information on the “Leak Test Theory” may be found vacuum cycle.
in Annex A1. Examples of test methods and test equipment used to
generate the precision and bias data in Section 12 are summarized in Table 6.3 Vacuum Decay Test System—The vacuum decay test
1. system includes a vacuum source for establishing the required

3
 F2338 − 09 (2020)

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FIG. 1 Schematic of Fixture and Porous Barrier Lidded Test Package

vacuum within the chamber at the beginning of the test cycle, 6.4 Mask or Block—The porous barrier lidding material of
and a pressure transducer (absolute or gauge), ASTM
aloneF2338-09(2020)
or in packages must be masked or blocked during testing to mini-
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combination with a second differential pressure transducer, for mize egress of air from the package through the lidding.
monitoring the vacuum level as well as the pressure change as Various masking techniques may be used, including a test
a function of time during the test cycle. Test systems intended chamber designed with a flexible bladder in the upper tooling
for higher target vacuums, such as +1 mbar or less, should be (refer to Fig. 1).
designed for greater target pressure measurement accuracy, 6.5 Volumetric Airflow Meter—An adjustable volumetric
with minimal system leakage and outgassing that may affect airflow meter is placed in-line with the test chamber to
test measurement signal to noise ratio. introduce an artificial leak at variable rates. It is recommended
NOTE 2—Different leak test instruments may utilize different pressure that an airflow meter be used to verify the leak test’s sensitivity.
transducer types and combinations, and vacuum pumps based on the NOTE 3—Refer to Annex A2 for further information about volumetric
package types tested (for example, rigid versus nonrigid, porous versus airflow meter use for verifying leak test sensitivity.
nonporous) and the vacuum level that is required to perform the test.
7. Hazards
6.3.1 Absolute versus Gauge Transducer—All instruments
includes a single 1000 Torr transducer for monitoring test 7.1 As the test chamber is closed, it may present pinch-point
pressure throughout the test cycle. An absolute transducer is hazards.
preferred over a gauge transducer when precise, true pressure
readings are required (that is, not subject to atmospheric 8. Preparation of Apparatus
pressure changes from weather or altitude). Such is the case 8.1 The test apparatus must be started, warmed-up, and
when performing high vacuum liquid leak tests. made ready according to the manufacturer’s specifications. For
6.3.2 Differential Transducer—A second differential pres- those instruments that rely on an internal, air-driven vacuum
sure transducer may be employed for measuring the smallest pump, the utilities required for instrument operation include
detectable leaks in rigid or semi-rigid nonporous packages. electrical power and a dry, non-lubricated compressed air
6.3.3 Vacuum Source—A vacuum pump is selected based on supply, according to manufacturer’s specifications. For those
the target vacuum level that must be achieved within the instruments that rely on an external vacuum pump, the utilities
allotted time frame given the test system airspace. required for instrument operation include electrical power

4
 F2338 − 09 (2020)

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ASTM F2338-09(2020)
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FIG. 2 Schematic of Fixture and Rigid, Nonporous Test Package

according to manufacturer’s specifications for both the instru- surface’s inherent porosity. A few control non-leaking pack-
ment and the vacuum pump. ages or a no-leak package mock-up must be used to select
critical test parameter settings.
9. Calibration and Standardization NOTE 4—Refer to Section 4 and Annex A1 for a description of critical
9.1 Before test measurements are made, the apparatus must test parameters.
be calibrated. The pressure transducers, any applicable vacuum 9.4 A larger sample population of control non-leaking
source pressure gauges, and the adjustable volumetric airflow packages must be used for optimizing critical test parameters.
meter must all be calibrated according to the manufacturer’s Control packages are to be made from the same materials and
recommended procedures and maintenance schedule. according to the same design as the test units.
9.2 Leak tests should be performed on the instrument test NOTE 5—Refer to Annex A2 for information on critical test parameter
selection.
system to verify a steady baseline leak rate. The test parameters
for start-up system qualification tests are typically recom- 9.5 Determine the sensitivity of the optimized leak test
mended by the instrument manufacturer. using control non-leaking test packages and a calibrated
9.3 Critical test parameter settings must be established for volumetric airflow meter.
each package/test fixture combination. Parameters will vary NOTE 6—Refer to Annex A2 for information about test sensitivity
based on the test package geometry and any porous barrier verification procedures.

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 F2338 − 09 (2020)

FIG. 3 Schematic of Test Chamber and Rigid, Nonporous Test Package

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9.6 Qualify the ability of the optimized test to reliably
differentiate between known non-leaking and defective pack-
10.7.1 If suspect fail results occur, verify the test chamber
and system functionality according to the leak test instrument

9.7 Test system baseline (https://standards.iteh.ai)

ages. manufacturer’s instructions prior to proceeding.
qualification (see 9.2) and test 10.7.2 If a failed test package contains product that may
sensitivity verification (see 9.5) are to be conducted frequently, have contaminated the test chamber or system during the leak
typically at least one or more times Document
a day, preferably at the Preview
test, perform steps to eliminate the contaminant from the test
beginning of every shift. chamber or system according to the leak test instrument
manufacturer’s instructions prior to proceeding.
10. Procedure ASTM F2338-09(2020)
10.8 Select another package and repeat the testing process.
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10.1 Select and install the appropriately sized test chamber
11. Report
for the package to be tested. Make any necessary adjustments
to the chamber to ensure a sufficiently tight seal of the chamber 11.1 For each package tested, report the values for the
lid (upper tooling) to the lower chamber package nest (lower following critical test parameters as well as package test
tooling) when the test chamber is in the closed position. results:
10.2 Verify the pressure level available at the supply source. 11.1.1 Pre-Test Vacuum expressed in seconds.
Check the functionality of the vacuum source. 11.1.2 Reserve Vacuum expressed in mbar or Pa, in either
positive absolute pressure units or negative pressure units
10.3 Program the test instrument with all necessary test (vacuum) relative to atmospheric pressure.
parameters and accept/reject criteria. 11.1.3 Target Vacuum expressed in mbar or Pa, in either
10.4 For those test methods that require a Pre-Test Vacuum positive absolute pressure units or negative pressure units
sequence prior to each test sample leak test, close the empty (vacuum) relative to atmospheric pressure.
test chamber and perform the required timed vacuum sequence. 11.1.4 Reference Vacuum expressed in mbar or Pa, in either
10.5 Place the assembled package into the lower tooling positive absolute pressure units or negative pressure units
nest and close the test chamber. Take appropriate steps to mask (vacuum) relative to atmospheric pressure.
or block any porous barrier surface of the package. 11.1.5 Reference Fill Time expressed in seconds.
NOTE 7—Inspect and clean the masking or blocking surface according 11.1.6 Equalization Time expressed in seconds.
to a regularly established routine according to the instrument manufac- 11.1.7 Test Time expressed in seconds.
turer’s recommended procedures to ensure effective masking of the porous 11.1.8 Reference Vacuum Decay Accept/Reject Limit ex-
barrier surface. pressed in Pa/s or Pa, in either positive absolute pressure units
10.6 Start the test. to describe allowable pressure rise, or negative pressure units
10.7 Note the pass or fail indicator or other means of (vacuum) to describe allowable vacuum loss.
detecting vacuum decay and document results. Identify and set 11.1.9 Accept/Reject Test Results.
aside any failed package for further evaluation. NOTE 8—Refer to Annex A1 for definitions of critical test parameters.

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 F2338 − 09 (2020)
TABLE 2 Gas Leak Detection Results—Nonlidded Tray
Approximate Success Rate
Number of Total Number of Number FAILED Number PASSED
Tray Size (cm) Tray Description (% accurate
Units Tested Replicate Tests (Leaks detected) (No leaks detected)
L×W×H replicate tests)
14 × 7 × 2 No defect 5 45 0 45 100
100 µm hole 4 36 36 0 100

17 × 13 × 2 No defect 5 45 0 45 100
50 µm hole 5 45 35 10A 78 (100)A
100 µm hole 5 45 45 0 100
A
Two test packages yielded all 10 PASS observations. An independent test laboratory later verified that the holes in these packages could no longer be located and may
have become clogged. In this case, the success rate is reported considering all 5 test trays (78 %), and considering only the 3 known defective trays (100 %).

The nomenclature used to describe critical test parameters may vary with completion of the study, the two suspect trays were indepen-
the equipment manufacturer, but the essential definitions remain un- dently reexamined for the presence and size of the holes. It was
changed.
determined that the holes could no longer be located and it was
12. Precision and Bias hypothesized that they had become clogged. These two trays
were eliminated from the precision statement.
12.1 Precision:
(2) Porous Barrier Lidded Trays—The test method is able
NOTE 9—Refer to Table 1 for a summary of the various test equipment, to identify defective packages sealed with porous barrier
test methods and packages used to generate the precision and bias data lidding material, tray holes of at least 100 µm in diameter, and
presented.
NOTE 10—All test results are expressed in qualitative terms (accept/ channel defects created using a 125 µm wire, when using a
reject). Precision and bias studies indicate the percentage of packages Target Vacuum of –4·E4 Pa (–400 mbar). As per the results
meeting the test criterion. outlined in Table 3, two populations of porous barrier lidded
NOTE 11—The vacuum decay instruments used in this round robin were tray packages were tested, representing two package sizes, all
manufactured by Packaging Technologies and Inspection. All available
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sealed with one type of coated porous barrier lidding material.
apparatus may not be suitable for this application. Apparatus considered
for use in this application shall be checked for suitability in accordance Defective samples included packages with a single hole in the
with the requirements in Section 6. tray wall (50 µm or 100 µm in diameter), and packages with a
12.1.1 Gas Leak Detection: (https://standards.iteh.ai)
12.1.1.1 Nonlidded and Porous Barrier Lidded Trays—An
single seal channel defect created using a wire of either 75 µm,
100 µm, or 125 µm in diameter (0.003, 0.004, and 0.005 in.,

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interlaboratory study was run in accordance with Practice E691
using a single pressure transducer (gauge) vacuum decay
respectively). An independent laboratory microscopically veri-
fied tray hole sizes, however seal channel sizes could not be
instrument.4 Three laboratories ran the study, each using a reliably verified.
separate instrument. Each laboratory performedASTM three replicate (3) Porous Barrier Lidded Trays with Various Adhesive
F2338-09(2020)
Bonding Systems—The test method is able to reliably identify
tests on each test sample. Test sample populations consisted of
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non-lidded semi-rigid (PETE) thermoformed trays, and trays packages with less than optimum seal bonding for dot matrix
sealed by means of various adhesive systems. The same test adhesive systems, and severely incomplete bonds made with
samples were tested at each laboratory. Test results are5 continuous adhesive systems at a Target Vacuum of –4·E4 Pa
qualitative in nature (Pass or Fail). Operators selected test (–400 mbar). Table 4 documents test results using two popu-
critical parameters for each sample population; therefore test lations of tray packages with porous barrier lidding material
results reflect operator, laboratory and instrument variability. representing two seal bonding adhesive systems. All lidding
Another single laboratory study was run testing the same materials consisted of the same porous barrier substrate.
vacuum decay instrument’s ability to detect air flow leaks Adhesives included dot matrix (C) and continuous (D) sys-
introduced into in test chambers containing packages with tems. Defective samples with incomplete seal bonding were
various porous barrier lidding material types. included. For dot matrix adhesive seals, defect severity was
(1) Nonlidded Trays—The test method is able to identify visually judged at the independent laboratory where the pack-
defective trays with holes ≥50 µm, when using a Target ages were sealed. Continuous adhesive seals could not be
Vacuum (Vac) of –4·E4 Pa (–400 mbar). As summarized in visually verified with accuracy; therefore, only sealing condi-
Table 2, two populations of non-lidded trays representing two tions were used to classify packages.
tray sizes were tested. Defective samples contained a single (4) Trays with Various Porous Barrier Lidding Materials—
hole in the tray wall of either 50 µm or 100 µm in diameter. The test method can be used to test packages sealed with
Two of the five larger trays, each with a 50 µm hole, repeatedly various porous barrier lidding material types, and tests are
failed to be detected at more than one test site, while the other similar in sensitivity (approximately E-2 Pa·m3·s-1 at a Target
three trays were consistently identified as leaking. At the Vacuum of –4·E4 Pa [–400 mbar]). Table 5 summarizes a
single laboratory study run using a single pressure transducer
(gauge) vacuum decay instrument4 to verify the test method’s
4
Model Pti VeriPac 225 by Packaging Technologies and Inspection, 145 Main
ability to evaluate semi-rigid thermoformed tray packages
Street, Tuckahoe, NY 10707. See Note 11.
5
Supporting data have been filed at ASTM International Headquarters and may sealed with various porous barrier lidding material types, and
be obtained by requesting Research Report RR:F02-1019. to obtain an estimate of the tests’ sensitivity.5 Critical test