ASTM-F1608 Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)

ASTM-F1608 - 2016 EDITION - CURRENT
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Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)
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Scope

1.1 This test method is used to determine the passage of airborne bacteria through porous materials intended for use in packaging sterile medical devices. This test method is designed to test materials under conditions that result in the detectable passage of bacterial spores through the test material.

1.1.1 A round-robin study was conducted with eleven laboratories participating. Each laboratory tested duplicate samples of six commercially available porous materials to determine the Log Reduction Value (LRV) (see calculation in Section 12). Materials tested under the standard conditions described in this test method returned average values that range from LRV 1.7 to 4.3.

1.1.2 Results of this round-robin study indicate that caution should be used when comparing test data and ranking materials, especially when a small number of sample replicates are used. In addition, further collaborative work (such as described in Practice E691) should be conducted before this test method would be considered adequate for purposes of setting performance standards.

1.2 This test method requires manipulation of microorganisms and should be performed only by trained personnel. The U.S. Department of Health and Human Services publication Biosafety in Microbiological and Biomedical Laboratories (CDC/NIH-HHS Publication No. 84-8395) should be consulted for guidance.

1.3 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.

Keywords

biological barrier; medical packaging; microbial barrier; microbial-challenge; porous packaging; sterile barrier; sterile packaging;; ICS Number Code 07.100.01 (Microbiology in general); 55.040 (Packaging materials and accessories)

To find similar documents by ASTM Volume:

15.10 (Packaging; Flexible Barrier Packaging)

To find similar documents by classification:

07.100.01 (Microbiology in general)

55.040 (Packaging materials and accessories Including wrappers, paper, films, foils, cords, sealing devices, cushioning, etc. Adhesive tapes for general purposes, see 83.180)

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Document Number

ASTM-F1608-16

Revision Level

2016 EDITION

Status

Current

Modification Type

Revision

Publication Date

June 15, 2016

Document Type

Test Method

Page Count

9 pages

Committee Number

F02.15