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D 4332 Practice for Conditioning Containers, Packages, or
Packaging Components for Testing tendencies for package failure when the package is exposed to
F 88 Test Method for Seal Strength of Flexible Barrier a pressure differential. Pressure differentials may occur during
Materials processes such as sterilization and transportation.
5.2 These test methods are frequently used to quickly
3. Terminology evaluate packages during the manufacturing process and at
3.1 Definitions of Terms Specific to This Standard: various stages of the packages life cycle.
3.1.1 flexibleindicates a material of the proper flexural 5.3 If correlations between pieces of test equipment are to
strength and thickness to permit a turn back at an appropriate be made, it is important that all parameters of the test method
180 angle. In order to fulfill all terms of the definition, at least be exactly the same. Typical parameters may include, but are
one of the sealed materials must be flexible. not limited to, package size, material, seal configuration, test
3.1.2 package failurerefers to rupture of seal or material. equipment, rate of air flow into the package, sensitivity
3.1.3 restrainta mechanism that prevents package move- (machine response to pressure drop), and position of test article
ment during inflation. (see Fig. 1).
5.4 These test methods do not necessarily provide correla-
4. Summary of Test Method tion with actual package seal strength as typically measured
4.1 Test Method A (Burst Test)Packages are tested in an using Test Method F 88 (or equivalent).
apparatus that internally pressurizes the package until the
6. Apparatus
1
6.1 Packages are tested under unrestrained conditions as
These test methods are under the jurisdiction of ASTM Committee F02 on follows:
Flexible Barrier Packaging and are the direct responsibility of Subcommittee F02.20
on Physical Properties. 6.1.1 Open Package Tester, used to test flexible packages
Current edition approved Aug. 1, 2007. Published August 2007. Originally with one opened side.
approved in 1988. Last previous edition approved in 2005 as F 1140 00 (2005). 6.1.2 Closed Package Tester, internally pressurizes the com-
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
pletely sealed package through a puncture.
Standards volume information, refer to the standards Document Summary page on 6.2 The test apparatus for both open and closed package
the ASTM website. testing shall include the following:
3
Withdrawn.
Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
7. Sampling
7.1 Choose the number of test specimens to permit an
adequate determination of representative performance. 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 ConditionsCondition 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 PreparationThe 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
specified parameters. The open package tester must be adjusted
such that the tester does not restrain the package from forming
its normal unrestricted height at the time of the burst.
NOTE 2The 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 PreparationThe 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 3It is important not to damage other package surfaces when
6.2.2 Timer, and inserting the needle. If the package material tears easily, reinforce the
6.2.3 Pressure Regulator, intended to maintain steady or 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 1If the pressure regulator cannot provide the necessary volume, process. The rate of pressurization may affect the test results
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Sr % SR %
Open package 49.11 3.67 7.47 6.39 13.01
Closed package 50.81 3.29 6.48 6.81 13.40
APPENDIX
(Nonmandatory Information)
X1.1 The testing of the seals of packages with porous method of blocking to ensure that the porous barrier area is
barrier materials may be limited due to the inability to provide consistently and uniformly covered or coated. When using
sufficient air volume. An example of this inability to provide labels or tape as blocking agents, it is important that the
sufficient air volume may be encountered when the package is blocking material does not reinforce the seal area being tested
so large that air leaks through the porous barrier faster than it on the package. When using non-solid blocking agents that
can be applied. Because of this air leakage, inadequate force require spreading over the porous barrier material, caution
due to lower pressure will not allow either the bursting of the must be used to ensure that the blocking agent does not affect
seals or reaching the desired holding pressure level. the seal bonding area by penetrating the porous barrier mate-
rial.
X1.2 Industry has typically responded to this effect by
limiting the porous barrier area. There are two major classifi- X1.3 Regardless of the method used, consistency of the
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cations of barrier blocking agents, the first being labels or tape, area blocked is necessary to provide minimum variability in the
and the second being non-solid agents that are spread across method. Validation of these techniques is necessary when used
the porous barrier material. Caution must be used with any for regulated products.
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