ASTM F2981-15

Standard Test Method for Verifying Nonporous Flexible Barrier Material Resistance to the Passage of Air

SIGNIFICANCE AND USE
3.1 This material challenge is presented in ISO-11607-1 Annex C as a normative test method to demonstrate that a material is nonporous and satisfies the microbial barrier requirements.
SCOPE
1.1 This test method is to be used to verify a specific material design property. Some flexible barrier materials are designed to have a resistance to the passage of air through the membrane structure. These materials are characterized as nonporous. This test method provides a means to verify this property by challenging a material with a given volume of air under pressure over a specific time period.  
1.2 This test method is not intended to measure the diffusion properties of a material nor to identify or quantify the presence of pinhole damage to the design that may result in leaks.  
1.3 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
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.

General Information

• Status: Historical
• Publication Date: 31-Mar-2015
• ICS: 11.080.30 - Sterilized packaging
• Technical Committee: F02 - Primary Barrier Packaging
• Drafting Committee: F02.20 - Physical Properties

Relations

• Replaced By: ASTM F2981-15(2020) - Standard Test Method for Verifying Nonporous Flexible Barrier Material Resistance to the Passage of Air
• Effective Date: 01-May-2020
• Referred By: ASTM F2097-20 - Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
• Effective Date: 01-Apr-2015

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F2981 − 15
Standard Test Method for
Verifying Nonporous Flexible Barrier Material Resistance to
1
the Passage of Air
This standard is issued under the fixed designation F2981; 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.
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1. Scope 2.3 TAPPI Standard:
TAPPI Test Method T 460 om-06Air Resistance of Paper
1.1 This test method is to be used to verify a specific
(Gurley Method)
material design property. Some flexible barrier materials are
designed to have a resistance to the passage of air through the
3. Significance and Use
membrane structure. These materials are characterized as
3.1 This material challenge is presented in ISO-11607-1
nonporous. This test method provides a means to verify this
Annex C as a normative test method to demonstrate that a
property by challenging a material with a given volume of air
material is nonporous and satisfies the microbial barrier re-
under pressure over a specific time period.
quirements.
1.2 Thistestmethodisnotintendedtomeasurethediffusion
propertiesofamaterialnortoidentifyorquantifythepresence
4. Apparatus
of pinhole damage to the design that may result in leaks.
4.1 Gurley Cylinder-type Densometer, or equivalent appa-
1.3 Units—The values stated in SI units are to be regarded
ratus compliant with ISO 5636-5.
asstandard.Nootherunitsofmeasurementareincludedinthis
4.1.1 Air Volume and Pressure, as standardized in TAPPI
standard.
T-460 and ISO 5636-5.
1.4 This standard does not purport to address all of the
4.2 Clock or Timer.
safety concerns, if any, associated with its use. It is the
4.3 Dimensional Scale, in 0.1 millimeter increments.
responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica-
5. Conditioning
bility of regulatory limitations prior to use.
5.1 Conditioning of samples will depend on the material
2. Referenced Documents
under evaluation. If conditioning before testing is appropriate,
2
normal and desirable, then condition the test specimens fol-
2.1 ASTM Standards:
lowing ASTM E171.
E171Practice for Conditioning and Testing Flexible Barrier
Packaging
3
6. Preparation and Procedure
2.2 ISO Standards:
ISO 11607-1Packaging for Terminally Sterilized Medical
6.1 Measureandcutsampleofmaterialtobetestedapproxi-
Devices—Part 1: Requirements for Materials, Sterile Bar- mately50mm×50mmsquare.Othercutsizesofsamplescan
rier Systems and Packaging Systems
be used if easier to manipulate and position in holder without
ISO 5636-5Paper and Board—Determination of Air Per- damage, wrinkling or introducing leaks.
meance and Air Resistance (Medium Range)—Part 5:
6.2 Prior to inserting the material, ensure that the column is
Gurley Method
raisedinthereadyposition.Loosenthewheelonthebottomof
densometer and place the web between the clamps. By insert-
1 ing the material samples with the smoother side facing upward
ThistestmethodisunderthejurisdictionofASTMCommitteeF02onFlexible
Barrier Packaging and is the direct responsibility of Subcommittee F02.20 on
toward the cylinder, the risk of leaking around the clamp is
Physical Properties.
minimized.
Current edition approved April 1, 2015. Published May 2015. DOI: 10.1520/
F2981-15.
6.3 Rotatethewheeltotherighttotightenuntilthematerial
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
is secure. (See Fig. 1.)
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
3 4
Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St., Available from TechnicalAssociation of the Pulp and Paper Industry (TAPPI),
4th Floor, New York, NY 10036, http://www.ansi.org. 15 Technology Parkway South, Norcross, GA 30092, http://www.tappi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F2981 − 15
6.8 Measure the position of the cylinder from positionAto
B in mm. Record end test distance.
6.9 Calculate and record the difference between start and
end distance measurements.
6.10 If the difference is less than or equal to 1 mm, the
materials are verified as nonporous.
6.11 When a material designed to be nonporous has results
greater than 1 mm, check for anomalies.
6.11.1 Check position of test sample and holder for air
leaking around sample.
6.11.2 Check that material is not damaged. Excessive wrin-
kling of material may create fractures in the structure.
7. Results
7.1 Record results as pass/fail.
...