Meaning and use

6.1 This Test methodology was developed by research conducted by Air Dispersion Limited (Manchester, UK) and funded by the Barrier Test Consortium Limited. The results of the study have been published in a peer-reviewed journal. 4 The study shows that the use of microorganisms to test the barrier properties of porous packaging materials is related to measuring the filtration efficiency of the materials.

6.2 This test method does not require the use of microbial methods; In addition, test methods can be performed quickly and in a timely manner.

6.3 When measuring the filtration efficiency of porous packaging materials, a typical filtration efficiency curve is determined (see Figure 1). Since the curvature of these curves depends on the properties of each material, the appropriate way to compare between materials is to use parameters that can measure the maximum permeability through the material.

Graph. 1 Typical curve shows the relationship between permeability and flow rate

A typical curve showing the relationship between permeability and flow rate

Note 1: The maximum penetration point is indicated by an upward triangle.

ASTM F2638-2018 Standard Test Method for Measuring the Performance of Porous Packaging Materials as Alternative Microbial Barriers Using Aerosol Filtration

6.4 Particle filtration is a quantitative procedure used to determine the microbial barrier properties of a material by challenging 1.0 µm particles over a differential pressure range from zero to approximately 30 cm water column (WC) (2942 Pa). The test method is based on Tallentire and Sinclair 4’s research and uses physical test methods to quickly determine microbial barrier performance.

Step 1: Scope

1.1 This test method measures the aerosol filtration performance of porous packaging materials by creating a defined 1.0μm particle aerosol and evaluating the filtration efficiency of the material using a single particle counter or a double particle counter.

1.2 This test method is applicable to porous materials used for packaging final sterilized medical devices.

1.3 The purpose of the test instrument is to determine the flow rate of the material through the maximum permeability.

1.4 Values expressed in SI units shall be considered standard. The values given in parentheses are for reference only.

1.5 This standard is not intended to address all safety concerns associated with its use. It is the responsibility of users of this standard to establish appropriate safety, health and environmental specifications and to determine the applicability of regulatory restrictions prior to use.

1.6 This international standard is based on internationally recognized standardization principles established in the Decision on Principles for the Development of International Standards, Guidelines and Recommendations issued by the WTO Technical Barriers to Trade (TBT) Committee.

ASTM F2638-2018 Standard Test Method for Measuring the Performance of Porous Packaging Materials as Alternative Microbial Barriers Using Aerosol Filtration

2. Refer to the file

ASTM standard

E171 / E171M Practices for regulating and testing flexible barrier packaging

E177 Practice of using the terms accuracy and deviation in ASTM test methods

E691 Practice of conducting inter-laboratory studies to determine the accuracy of test methods