ASTM F2095-07(2021)
(Test Method)Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates
Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates
SIGNIFICANCE AND USE
5.1 These test methods provide a rapid, simple to apply method to detect small leaks in flexible package seals or walls at the leak rate level of greater than 1 × 10−4 sccs, thus providing a measure of package integrity. Porous barrier film packages made non-porous with an impermeable film forming coating may demonstrate lateral leakage through the barrier material. Verification of leakage differences from background leakage must be included in validation methods. The use of calibrated hole sizes or orifices may be appropriate to determine leakage sensitivity or barrier integrity for these materials.
5.2 While theoretical leak rate sensitivity can be established by calculation, the test measurement is in pressure units and the measuring instrument must be calibrated, certified, and verified with these units.
5.3 The pressure decay method of leak testing is a physical measure of package integrity. When testing medical packaging which must conform to ISO 11607–1: 2006 standards, it may necessary to verify the results of the pressure decay test method with other sterile package integrity test methods.
5.4 Test Method A allows packages to be pressurized without restraint. In Test Method A the pouch, tray, or other type package will contain a volume of air defined by its mechanical configuration and its ability to resist internal pressure applied. This test method requires that the package reach a stable volume configuration (stop stretching) to make a measurement.
5.5 Test Method B allows the use of rigid restraining plates against the walls of the package to limit its volume and stabilize the package volume.
SCOPE
1.1 These test methods cover the measurement of leaks in nonporous film, foil, or laminate flexible pouches and foil-sealed trays, which may be empty or enclose solid product. If product is enclosed, seals or surfaces cannot be in contact with water, oils, or other liquid.
1.2 These test methods will detect leaks at a rate of 1 × 10−4 sccs (standard cubic centimetres per second) or greater, in flexible packages. The limitation of leak rate is dependent on package volume as tested.
1.3 The following test methods are included:
1.3.1 Test Method A—Pressure Decay Leak Test for Flexible Packages Without Restraining Plates
1.3.2 Test Method B—Pressure Decay Leak Test for Flexible Packages With Restraining Plates
1.4 These test methods are destructive in that they require entry into the package to supply an internal pressure of gas, typically air or nitrogen, although other gases may be used. The entry connection into the flexible package must be leak-tight.
1.5 For porous packages, see 9.3.
1.6 The values stated in SI units are to be regarded as standard. The values given in parentheses after SI units are provided for information only and are not considered standard.
1.7 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.
1.8 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.
General Information
Relations
Standards Content (Sample)
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: F2095 − 07 (Reapproved 2021)
Standard Test Methods for
Pressure Decay Leak Test for Flexible Packages With and
Without Restraining Plates
This standard is issued under the fixed designation F2095; 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 2. Referenced Documents
1.1 These test methods cover the measurement of leaks in
2.1 ASTM Standards:
nonporous film, foil, or laminate flexible pouches and foil-
D4332Practice for Conditioning Containers, Packages, or
sealed trays, which may be empty or enclose solid product. If
Packaging Components for Testing
product is enclosed, seals or surfaces cannot be in contact with
E177Practice for Use of the Terms Precision and Bias in
water, oils, or other liquid.
ASTM Test Methods
−4
E691Practice for Conducting an Interlaboratory Study to
1.2 Thesetestmethodswilldetectleaksatarateof1×10
Determine the Precision of a Test Method
sccs (standard cubic centimetres per second) or greater, in
F17Terminology Relating to Primary Barrier Packaging
flexible packages. The limitation of leak rate is dependent on
package volume as tested.
2.2 Other Document:
ANSI/AAMI/ISO11607–1:2006Packaging for Terminally
1.3 The following test methods are included:
Sterilized Medical Devices—Part 1: Requirements for
1.3.1 Test Method A—PressureDecayLeakTestforFlexible
Materials, Sterile Barrier Systems, and Packaging Sys-
Packages Without Restraining Plates
tems
1.3.2 Test Method B—PressureDecayLeakTestforFlexible
Packages With Restraining Plates
3. Terminology
1.4 These test methods are destructive in that they require
3.1 Definitions of Terms Specific to This Standard:
entry into the package to supply an internal pressure of gas,
typicallyairornitrogen,althoughothergasesmaybeused.The 3.1.1 integrity, n—the unimpaired physical condition of the
entry connection into the flexible package must be leak-tight. package. This implies that there are no leaks in the seals or
body materials.
1.5 For porous packages, see 9.3.
3.1.2 leak, n—see Terminology F17.
1.6 The values stated in SI units are to be regarded as
standard. The values given in parentheses after SI units are
3.1.3 nonporous, adj—types of materials that are not pur-
providedforinformationonlyandarenotconsideredstandard.
posely designed to transfer gases through their matrix.
1.7 This standard does not purport to address all of the
3.1.4 restraining plates, n—plates of rigid material, for
safety concerns, if any, associated with its use. It is the
example, aluminum, that are used to restrict the movement of
responsibility of the user of this standard to establish appro-
the package during inflation.
priate safety, health, and environmental practices and deter-
3.1.5 seal, n—see Terminology F17.
mine the applicability of regulatory limitations prior to use.
1.8 This international standard was developed in accor-
3.1.6 standard cubic centimetre per second (sccs), n—the
dance with internationally recognized principles on standard-
flow rate of a gas (air) at standard conditions of 20°C (68°F)
ization established in the Decision on Principles for the
and 101.3 kPa (14.7 psig) (1 atmosphere or 760 mm Hg).
Development of International Standards, Guides and Recom-
3.1.6.1 Discussion—Conditions may be varied depending
mendations issued by the World Trade Organization Technical
on the source of data.Always check the definition being used.
Barriers to Trade (TBT) Committee.
1 2
These test methods are under the jurisdiction of ASTM Committee F02 on For referenced ASTM standards, visit the ASTM website, www.astm.org, or
PrimaryBarrierPackagingandarethedirectresponsibilityofSubcommitteeF02.40 contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
on Package Integrity. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved Jan. 15, 2021. Published February 2021. Originally the ASTM website.
approved in 2001. Last previous edition approved in 2013 as F2095–07 (2013). Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
DOI: 10.1520/F2095-07R21. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F2095 − 07 (2021)
4. Summary of Test Method 5.3 The pressure decay method of leak testing is a physical
measure of package integrity.When testing medical packaging
4.1 Detection of leak paths in flexible packages that have
which must conform to ISO 11607–1: 2006 standards, it may
nonporous material surfaces and seals can be accomplished by
necessarytoverifytheresultsofthepressuredecaytestmethod
pressurization of the package to a fixed pressure, shutting off
with other sterile package integrity test methods.
the pressure and connecting a pressure transducer. Observed
changes in pressure indicate the presence of leakage paths in 5.4 Test Method A allows packages to be pressurized
the package seals or pinholes in the surfaces.This leak may be without restraint. In Test Method A the pouch, tray, or other
represented in decay pressure units or calculated leak rate type package will contain a volume of air defined by its
units. To accomplish this technique, a leak-tight measuring mechanical configuration and its ability to resist internal
path must be available between the package interior volume pressure applied. This test method requires that the package
and the pressure transducer (see Fig. 1). reachastablevolumeconfiguration(stopstretching)tomakea
measurement.
NOTE 1—The coating used on porous barrier films will mask defects
(pin-holes) in/through the porous material but not defects in the seals.
5.5 Test Method B allows the use of rigid restraining plates
against the walls of the package to limit its volume and
4.2 Restraining plates may be used to limit the volume of
stabilize the package volume.
the pressurized package. Because the sensitivity of these test
methods is dependent in part on the internal volume of the
6. Apparatus
package, the effect of restraining plate use is to increase the
sensitivity of the test (seeFig. 2). See Appendix X1 for further
6.1 Test Method A:
discussion of the effects of restraining plates on these test
6.1.1 A measuring instrument that provides the following:
methods.
6.1.1.1 A means to detect pressure changes with sufficient
sensitivity to achieve theoretical leak rates in the package
5. Significance and Use
specification;
5.1 These test methods provide a rapid, simple to apply
6.1.1.2 Automatic timer controls to pressurize the package
method to detect small leaks in flexible package seals or walls
to a preset pressure, hold the pressure for a set time, and
−4
at the leak rate level of greater than1×10 sccs, thus
provide a time period during which pressure change data can
providing a measure of package integrity. Porous barrier film
be taken;
packages made non-porous with an impermeable film forming
6.1.1.3 A means to set pressure;
coating may demonstrate lateral leakage through the barrier
6.1.1.4 A means of holding and displaying the pressure
material. Verification of leakage differences from background
change inside the package at the end of the test cycle;
leakage must be included in validation methods. The use of
6.1.1.5 Ameans (optional) to set pressure decay limits for a
calibrated hole sizes or orifices may be appropriate to deter-
test method and alert the operator if the limit is exceeded.
mineleakagesensitivityorbarrierintegrityforthesematerials.
6.1.2 Ameanstoenterthepackageinaleaktightmannerso
that an inflation pressure can be applied to the package and
5.2 Whiletheoreticalleakratesensitivitycanbeestablished
changes in internal pressure can be sensed.
bycalculation,thetestmeasurementisinpressureunitsandthe
measuringinstrumentmustbecalibrated,certified,andverified
NOTE 2—It is important to verify the leak integrity of the entry means
with these units. sothatitdoesnotcontributetothepressurechangessensedduringtesting.
FIG. 1 Leak-Tight Entry System
F2095 − 07 (2021)
FIG. 2 Restraining Fixture with Leak-Tight Entry System
6.2 Test Method B—Using Restraining Plates: 23 62°C (73 64°F) and 50 65% relative humidity. Other
6.2.1 The measuring instrument shall have the characteris- conditions should be recorded at the time of the test.
tics described in 6.1.1.1 – 6.1.1.5.
NOTE 5—As seen in the combined gas laws, the pressure change is a
6.2.2 Parallel, rigid plates are required. An ability to adjust
functionoftemperature.Testpackagesandthetestmedium(air)shouldbe
plate separation is desirable. The surface of the plates should
at similar temperatures.
providelimitedporosityinordertopreventblockingofpinhole
9. Procedure
leaks in the walls (see Fig. 2).
9.1 Test Method A—No Restraining Plates:
NOTE 3—Several techniques have been used to provide a means to
prevent blocking or lowering of the leak rate in package material walls in 9.1.1 Package Preparation—The package may be tested
contact with the plates. These techniques include the use of semi-porous
with or without the product enclosed. To maximize sensitivity
plastic, scoring of plate surfaces and use of screen-type materials.
of the test, the smallest internal volume of the package is
6.2.3 Ameanstoenterthepackageinaleak-tightmannerso
desired.
that an inflation pressure can be applied to the package and
9.1.2 Instrument Preparation (see Annex A1 for informa-
changes in internal pressure can be sensed.
tion on determining appropriate test parameters):
9.1.2.1 Select and set the test pressure.
NOTE 4—It is important to verify the leak integrity of the entry means
9.1.2.2 Select and set the timers for charge (pressurization),
sothatitdoesnotcontributetothepressurechangessensedduringtesting.
settle (stabilization), and test (data taking period).
7. Sampling
9.1.2.3 Select and set pressure decay limits (if available).
9.1.3 Attach the inflation probe (supply and sensor) to the
7.1 The sample size is chosen to permit an adequate
instrument.
determination of representative performance.
9.1.4 Attach the leak-tight entry device and inflation probe
7.2 Sample identification should be made prior to testing to
sensor to the package (see Fig. 1).
allowtheoperatortorefertospecifictestsamples,ifnecessary.
9.1.5 Begin the test by activating the timer controls and
Record information such that test results and anomalies are
valves to inflate, hold, and measure the test pressure inside the
identifiable back to the individual specimens.
package.
9.1.6 Observe the pressure decay at the end of the test time
8. Conditioning
period, and note if the pressure decay limit has been exceeded.
8.1 Package samples should be conditioned to obtain the
NOTE 6—Choice of times depends on package variables and leak rate
same temperature conditions as exist for the test apparatus.
requirements. For example, small changes in initial test pressure may
Since measured pressure change is also a function of
occur from flexible package stretch, thus slightly increasing its volume
temperature, then the samples must be at a stable temperature.
(decreasing its pressure) or from fixture contact or the expanding gas
Most testing will occur at standard laboratory conditions of medium. Increased stabilization time will allow these effects to become
F2095 − 07 (2021)
stable before the test data period begins. Test times are selected based on
10.1.3 Whether the package was tested empty or filled with
required leakage rates or pressure decay criteria along with the package
product.
volume. See Annex A1 for further discussion.
10.1.4 The apparatus used and settings for test pressure,
9.2 Test Method B—With Restraining Plates:
timers,anddecaylimits.Otheroptionalapparatussettingsmay
9.2.1 Package Preparation—The package may be tested
be recorded such as restraining plate gap.
with or without the product enclosed. To maximize sensitivity
10.1.5 Date, time, location, and operator’s name.
of the test, the smallest internal volume of the package is
10.1.6 Conditioning parameters and environmental condi-
desired. To achieve the minimum volume, the smallest gap
tions at the time of test (if applicable).
between restraining plates is advisable.
10.1.7 Package test number and pressure decay if pressure
9.2.2 Instrument Preparation (see Annex A1 for informa-
decay limit was exceeded.
tion on determining appropriate test parameters):
11. Precision and Bias
9.2.2.1 Select and set the test pressure.
9.2.2.2 Select and set the timers for charge (pressurization),
11.1 This interlaboratory study was conducted to evaluate
settle (stabilization), and test (data taking period).
the precision of the pressure decay test method of leak
9.2.2.3 Select and set pressure decay limits (if available).
detection in identifying a known leak in various sealed,
9.2.3 Attach the inflation probe (supply and sensor) to the
nonporous empty packages. Two variations of the test method
instrument.
were examined, with Test Method A allowing the pressurized
9.2.4 Attach the leak-tight entry device and inflation probe
packages to expand without restraint, and Test Method B
sensor to the package (Fig. 1).
utilizing rigid restraining plates to limit package expansion
9.2.5 Enclose the package and probe in the restraining
under pressurization. Each of five laboratories tested ten
fixture.
randomly drawn test specimens from each of three materials
9.2.6 Begin the test by activating the timer controls and
under each of the two test methods, A and B. Materials were
valves to inflate, hold, and measure the test pressure inside the
chosen to represent a range of products for which the test
package.
methodsaresuitable.Thedesignoftheexperimentwassimilar
9.2.7 Observe the pressure decay at the end of the test time
to that of Practice E691.
period and note if the pressure decay limit has been exceeded.
11.2 The precision information given as follows represents
NOTE 7—Choice of times depends on package variables and leak rate pressure decay as measured in psig. The terms “repeatability
requirements. For example, small changes in initial test pressure may
limit” and “reproducibility limit” are used in accordance with
occur from flexible package stretch, thus slightly increasing its volume
Practice E177.
(decreasing its pressure) or from fixture contact or the expan
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