ASTM F2638-12e1

Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier

SIGNIFICANCE AND USE
6.1 This test method has been developed as a result of research performed by Air Dispersion Limited (Manchester, UK) and funded by the Barrier Test Consortium Limited. The results of this research have been published in a peer-reviewed journal.4 This research demonstrated that testing the barrier performance of porous packaging materials using microorganisms correlates with measuring the filtration efficiency of the materials.  
6.2 This test method does not require the use of microbiological method; in addition, the test method can be conducted in a rapid and timely manner.  
6.3 When measuring the filtration efficiency of porous packaging materials a typical filtration efficiency curve is determined (see Fig. 1). Since the arc of these curves is dependent upon the characteristics of each individual material, the appropriate way to make comparison among materials is using the parameter that measures maximum penetration through the material.
Note 1: The point of maximum penetration is indicated by the upward pointing triangle.  
6.4 The particle filtration method is a quantitative procedure for determining the microbial barrier properties of materials using a challenge of 1.0 µm particles over range of pressure differentials from near zero to approximately 30 cm water column (WC). This test method is based upon the research of Tallentire and Sinclair4 and uses physical test methodology to allow for a rapid determination of microbial barrier performance.
SCOPE
1.1 This test method measures the aerosol filtration performance of porous packaging materials by creating a defined aerosol of 1.0 μm particles and assessing the filtration efficiency of the material using either single or dual particle counters.  
1.2 This test method is applicable to porous materials used to package terminally sterilized medical devices.  
1.3 The intent of this test method is to determine the flow rate through a material at which maximum penetration occurs. The porous nature of some materials used in sterile packaging applications might preclude evaluation by means of this test method. The maximum penetration point of a particular material could occur at a flow rate that exceeds the flow capacity of the test apparatus. As such, this test method may not be useful for evaluating the maximum penetration point of materials with a Bendtsen flow rate above 4000 mL/min as measured by ISO 5636–3.  
1.4 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.  
1.5 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: 30-Apr-2012
• ICS: 55.040 - Packaging materials and accessories
• Technical Committee: F02 - Primary Barrier Packaging
• Drafting Committee: F02.15 - Chemical/Safety Properties

Relations

• Replaces: ASTM F2638-12 - Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier
• Effective Date: 01-May-2012
• Referred By: ASTM F2097-20 - Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
• Effective Date: 01-May-2012

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
´1
Designation: F2638 − 12
Standard Test Method for
Using Aerosol Filtration for Measuring the Performance of
Porous Packaging Materials as a Surrogate Microbial
1
Barrier
This standard is issued under the fixed designation F2638; 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
ε NOTE—The research report designation was added editorially in November 2016.
1. Scope 2. Referenced Documents
2
1.1 This test method measures the aerosol filtration perfor- 2.1 ASTM Standards:
mance of porous packaging materials by creating a defined E177 Practice for Use of the Terms Precision and Bias in
aerosol of 1.0 µm particles and assessing the filtration effi- ASTM Test Methods
ciency of the material using either single or dual particle E691 Practice for Conducting an Interlaboratory Study to
counters. Determine the Precision of a Test Method
3
2.2 ISO Standard:
1.2 This test method is applicable to porous materials used
ISO 5636–3 Paper and Board—Determination of Air Per-
to package terminally sterilized medical devices.
meance (Medium Range)—Part 3: Bendtsen Method
1.3 The intent of this test method is to determine the flow
3. Terminology
rate through a material at which maximum penetration occurs.
The porous nature of some materials used in sterile packaging
3.1 Definitions:
applications might preclude evaluation by means of this test
3.1.1 challenge aerosol—a sufficient quantity of aerosolized
method. The maximum penetration point of a particular mate-
1.0 µm particles that enable effective particle counting in the
rial could occur at a flow rate that exceeds the flow capacity of
filtrate aerosol.
the test apparatus.As such, this test method may not be useful
3.1.2 filtrate aerosol—particlesthatremainaerosolizedafter
forevaluatingthemaximumpenetrationpointofmaterialswith
passage through the test specimen.
a Bendtsen flow rate above 4000 mL/min as measured by
3.1.3 maximum penetration—the highest percent concentra-
ISO 5636–3.
tionofparticlesinthefiltrateaerosolwhenaspecimenistested
1.4 The values stated in SI units are to be regarded as the
over a range of pressure differentials or air flow rates.
standard. The values given in parentheses are for information
3.2 Abbreviations and Symbols:
only.
Symbol Unit Description
1.5 This standard does not purport to address all of the
C n Average particle count of the challenge aerosol
S
safety concerns, if any, associated with its use. It is the
when using a single particle counter (Method A).
C n Average particle count of the filtrate aerosol.
responsibility of the user of this standard to establish appro-
F
C n Average particle count of the challenge aerosol.
C
priate safety and health practices and determine the applica-
C N Average particle count of the filtrate aerosol prior to
LR
bility of regulatory limitations prior to use.
correction for dilution.
1 2
This test method is under the jurisdiction ofASTM Committee F02 on Primary For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Barrier Packaging and is the direct responsibility of Subcommittee F02.15 on contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Chemical/Safety Properties. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved May 1, 2012. Published June 2012. Originally
the ASTM website.
3
approved in 2007. Last previous edition approved in 2007 as F2638 – 07. DOI:
Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F2638-12E01. 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
1

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F2638 − 12
5.4 The reported results are the maximum penetration and
Symbol Unit Description
R % Percentage of particles from the challenge aerosol
the flow rate at which it occurs.
that remain in the filtrate aerosol.
R % The calculated maximum of R.
M
6. Significance and Use
P
cm WC Pressure differential across a test specimen due to
1
the air flow required by the particle counter.
6.1 This test method has been developed as a result of
P cm WC Pressure differential across a test specimen.
2
research performed by Air Dispersion Limited (Manchester,
F L/m/cm Air flow rate through the test specimen.
2
F L/m/cm Air flow rate required by the particle counter when
1 UK) and funded by the Barrier Test Consortium Limited. The
measuring the filtrate aerosol.
results of this research have been published in a peer-reviewed
2
F L/m/cm Air flow rate at which maxi
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
´1
Designation: F2638 − 12 F2638 − 12
Standard Test Method for
Using Aerosol Filtration for Measuring the Performance of
Porous Packaging Materials as a Surrogate Microbial
1
Barrier
This standard is issued under the fixed designation F2638; 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
ε NOTE—The research report designation was added editorially in November 2016.
1. Scope
1.1 This test method measures the aerosol filtration performance of porous packaging materials by creating a defined aerosol
of 1.0 μm particles and assessing the filtration efficiency of the material using either single or dual particle counters.
1.2 This test method is applicable to porous materials used to package terminally sterilized medical devices.
1.3 The intent of this test method is to determine the flow rate through a material at which maximum penetration occurs. The
porous nature of some materials used in sterile packaging applications might preclude evaluation by means of this test method.
The maximum penetration point of a particular material could occur at a flow rate that exceeds the flow capacity of the test
apparatus. As such, this test method may not be useful for evaluating the maximum penetration point of materials with a Bendtsen
flow rate above 4000 mL/min as measured by ISO 5636–3.
1.4 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.
1.5 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.
2. Referenced Documents
2
2.1 ASTM Standards:
E177 Practice for Use of the Terms Precision and Bias in ASTM Test Methods
E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
3
2.2 ISO Standard:
ISO 5636–3 Paper and Board—Determination of Air Permeance (Medium Range)—Part 3: Bendtsen Method
3. Terminology
3.1 Definitions:
3.1.1 challenge aerosol—a sufficient quantity of aerosolized 1.0 μm particles that enable effective particle counting in the filtrate
aerosol.
3.1.2 filtrate aerosol—particles that remain aerosolized after passage through the test specimen.
3.1.3 maximum penetration—the highest percent concentration of particles in the filtrate aerosol when a specimen is tested over
a range of pressure differentials or air flow rates.
3.2 Abbreviations and Symbols:
1
This test method is under the jurisdiction of ASTM Committee F02 on FlexiblePrimary Barrier Packaging and is the direct responsibility of Subcommittee F02.15 on
Chemical/Safety Properties.
Current edition approved May 1, 2012. Published June 2012. Originally approved in 2007. Last previous edition approved in 2007 as F2638 – 07. DOI:
10.1520/F2638-12.10.1520/F2638-12E01.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or 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
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 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
1

---------------------- Page: 1 ----------------------
´1
F2638 − 12
Symbol Unit Description
C n Average particle count of the challenge aerosol
S
when using a single particle counter (Method A).
C n Average particle count of the filtrate aerosol.
F
C n Average particle count of the challenge aerosol.
C
C N Average particle count of the filtrate aerosol prior to
LR
correction for dilution.
R % Percentage of particles from the challenge aerosol
that remain in the filtrate aerosol.
R % The calculated maximum of R.
M
P cm WC Pressure differential across a test specimen due to
1
the air flow required by the particle counter.
P cm WC Pressure differential across a test specimen.
2
F L/m/cm Air flow rate through the test specimen.
2
F L/m/cm Air flow rate required by the particle counter when
1
measuring the filtrate aerosol.
2
F L/m/cm Air flow rate at which maximum penetration occurs.
M
4. Safety
4.1 The wa
...