ASTM F2638-12e1
Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier

Standard No.

ASTM F2638-12e1

Release Date

2012

Published By

American Society for Testing and Materials (ASTM)

Status

Be replaced

Replace By

ASTM F2638-18

Latest

ASTM F2638-22

Scope

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.

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 ISO8201;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 standa......

ASTM F2638-12e1 Referenced Document

• ASTM E177 Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods
• ASTM E691 Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method

ASTM F2638-12e1 history

• 2022 ASTM F2638-22 Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier
• 2018 ASTM F2638-18 Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier
• 2012 ASTM F2638-12e1 Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier
• 2012 ASTM F2638-12 Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier
• 2007 ASTM F2638-07 Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier