ASTM-F2638 2012

$44.96

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

Published By	Publication Date	Number of Pages
ASTM	2012	17

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Category: ASTM

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Description

ASTM F2638-12

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

ASTM F2638

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.

Keywords

filtration efficiency; medical packaging; microbial barrier; microbial challenge; particulate barrier; porous packaging; sterile barrier; sterile packaging; Aerosol filtration; Microbial contamination; Performance; Porous packaging materials

ICS Code

ICS Number Code 55.040 (Packaging materials and accessories)

DOI: 10.1520/F2638-12

PDF Catalog

PDF Pages	PDF Title
1	Scope Referenced Documents Terminology Safety
2	Summary of Test Method Significance and Use FIG. 1
3	Apparatus FIG. 2
4	FIG. 3
5	Materials FIG. 4
6	Apparatus Preparation Sample Preparation Test Procedures TABLE 1
7	FIG. 5
8	Data Analysis FIG. 6
9	Report Precision and Bias Keywords TABLE 2 TABLE 3
10	FIG. 7
11	FIG. 8
12	X1. ARRANGEMENT OF CONTROL VALVES FIG. X1.1
13	X2. ANALYSIS OF A TYPICAL DATA SET X2.1 X2.2 X2.3 X2.4 X2.5 X2.6 X2.7 X2.8 X2.9 X2.10 X2.11 TABLE X2.1
14	FIG. X2.1
15	FIG. X2.2 TABLE X2.2 TABLE X2.3
16	FIG. X2.3 FIG. X2.4

Additional information

Standard Title	F2638-12 Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier
Published Code	ASTM
Publication Date	2012
Pages Count	17