ASTM F1140-00(2005)
(Test Method)Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages for Medical Applications
Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages for Medical Applications
SCOPE
1.1 These test methods explain the procedure for determining the ability of packages to withstand internal pressurization.
1.2 The burst test increasingly pressurizes the package until the package fails.
1.3 The creep test maintains a specified pressure for a specified time or until the package fails.
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 and health practices and determine the applicability of regulatory limitations prior to use.
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Designation:F1140–00 (Reapproved 2005)
Standard Test Methods for
Internal Pressurization Failure Resistance of Unrestrained
Packages for Medical Applications
This standard is issued under the fixed designation F 1140; 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 package fails. The pneumatic supply and pressurization equip-
ment need the capability to maintain an increasing pressure
1.1 These test methods explain the procedure for determin-
until the package bursts. The test measure is the maximum
ing the ability of packages to withstand internal pressurization.
pressure detected before the package fails.
1.2 The burst test increasingly pressurizes the package until
4.2 Test Method B (Creep Test)—Packages are tested in
the package fails.
apparatus that internally pressurizes the package to a specified
1.3 The creep test maintains a specified pressure for a
pressure and maintains that internal package pressure for a
specified time or until the package fails.
specific time. The test measure is pass/fail.
1.4 This standard does not purport to address all of the
4.3 Test Method B (Creep to Failure)—Packagesarecreep-
safety concerns, if any, associated with its use. It is the
tested and held until the package fails. Test setup is similar to
responsibility of the user of this standard to establish appro-
that of the Creep Test except the pressure setting will need to
priate safety and health practices and determine the applica-
be higher to ensure the package fails in a reasonable amount of
bility of regulatory limitations prior to use.
time (that is, about 15 s). The test measure is the time until
2. Referenced Documents failure.
2.1 ASTM Standards:
5. Significance and Use
D 1898 Practice for Sampling of Plastics
5.1 These test methods provide a rapid means of evaluating
D 4332 Practice for Conditioning Containers, Packages, or
tendencies for package failure when the package is exposed to
Packaging Components for Testing
a pressure differential. Pressure differentials may occur during
F88 Test Method for Seal Strength of Flexible Barrier
processes such as sterilization and transportation.
Materials
5.2 These test methods are frequently used to quickly
3. Terminology
evaluate packages during the manufacturing process and at
various stages of the package’s life cycle.
3.1 Definitions of Terms Specific to This Standard:
5.3 If correlations between pieces of test equipment are to
3.1.1 flexible—indicates a material of the proper flexural
be made, it is important that all parameters of the test method
strength and thickness to permit a turn back at an appropriate
be exactly the same. Typical parameters may include, but are
180° angle. In order to fulfill all terms of the definition, at least
not limited to, package size, material, seal configuration, test
one of the sealed materials must be flexible.
equipment, rate of air flow into the package, sensitivity
3.1.2 package failure—refers to rupture of seal or material.
(machineresponsetopressuredrop),andpositionoftestarticle
3.1.3 restraint—a mechanism that prevents package move-
(see Fig. 1).
ment during inflation.
5.4 These test methods do not necessarily provide correla-
4. Summary of Test Method
tion with actual package seal strength as typically measured
using Test MethodF88 (or equivalent).
4.1 Test Method A (Burst Test)—Packages are tested in an
apparatus that internally pressurizes the package until the
6. Apparatus
6.1 Packages are tested under unrestrained conditions as
These test methods are under the jurisdiction of ASTM Committee F02 on
follows:
Flexible Barrier Materials and are the direct responsibility of Subcommittee F02.20
6.1.1 Open Package Tester, used to test flexible packages
on Physical Properties.
Current edition approved April 1, 2005. Published May 2005. Originally with one opened side.
approved in 1988. Last previous edition approved in 2000 as F 1140 – 00.
6.1.2 Closed Package Tester,internallypressurizesthecom-
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
pletely sealed package through a puncture.
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
6.2 The test apparatus for both open and closed package
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
testing shall include the following:
Withdrawn.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F1140–00 (2005)
the porosity of the sample may need to be limited.
7. Sampling
7.1 Choose the number of test specimens to permit an
adequatedeterminationofrepresentativeperformance.Practice
D 1898 provides guidance to test specimen selection. Testing
of specimens with visual defects or other deviations from
normality may or may not be appropriate, depending on the
purpose of investigation. Indiscriminate elimination of defects
can bias results.
8. Conditioning
8.1 Standard Test Conditions—Condition packages and
conduct testing in accordance with Practice D 4332.
8.2 If the test methods are conducted in other than standard
test conditions, record the temperature and relative humidity at
the time of the test method.
9. Procedure
9.1 Test Method A (Burst Test)—Place the package in the
apparatus and increase the internal pressure until a failure
occurs.
9.1.1 Open Package Test:
9.1.1.1 Package Preparation—The package may be tested
with or without the product enclosed. Record the package test
preparation.
9.1.1.2 Place the package in the test apparatus, and set the
specifiedparameters.Theopenpackagetestermustbeadjusted
such that the tester does not restrain the package from forming
its normal unrestricted height at the time of the burst.
NOTE 2—The package is typically positioned in one of the positions
shown in Fig. 1. Different positions may result in different test values and,
therefore, the final report should specify which position was chosen.
9.1.1.3 Begin the test method by starting the inflation
process. The rate of pressurization may affect the test results
and must not exceed the response rate of the pressure indicator.
Continue pressurization until a failure occurs.
9.1.1.4 Visually examine the package, and note the position
and type of failure (material or seal) and the pressure at which
it occurred.
9.1.2 Closed Package Test:
9.1.2.1 Package Preparation—The package may be tested
with or without the product enclosed. Record the package test
preparation.
9.1.2.2 Position the completely sealed package in the test
apparatus and carefully insert the pressurization entry device
(see Fig. 2). The center of the package is the preferred point of
entry. Location variations of the entry point may affect the
FIG. 1 Open Package Test Positions
results of the test. Record the location of entry and perform all
sample testing at this same location.
6.2.1 Means of Measuring the Pressure Inside the Package,
NOTE 3—Caution: It is important not to damage other package sur-
6.2.2 Timer, and
faces when inserting the needle. If the package material tears easily,
6.2.3 Pressure Regulator, intended to maintain steady or
reinforce the point of entry with tape or equivalent.
increasing pressure in the package.
9.1.2.3 Begin the test method by starting the inflation
NOTE 1—Ifthepressureregulatorcannotprovidethenecessaryvolume, process. The rate of pressurization may affect the test results
F
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