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

ASTM-F1608 - 2016 EDITION - CURRENT
Show Complete Document History

Document Center Inc. is an authorized dealer of ASTM standards.
The following bibliographic material is provided to assist you with your purchasing decision:

Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)
ORDER

Price:

$50.00        


Want this as a site license?

Changes from the previous issue

A redline edition is available for this document, with all changes visible. Ask Document Center Inc. for more information.

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.

Significance and Use

5.1 The exposure-chamber method is a quantitative procedure for determining the microbial-barrier properties of porous materials under the conditions specified by the test. Data obtained from this test is useful in assessing the relative potential of a particular porous material in contributing to the loss of sterility to the contents of the package versus another porous material. This test method is not intended to predict the performance of a given material in a specific sterile-packaging application. The maintenance of sterility in a particular packaging application will depend on a number of factors, including, but not limited to the following:

5.1.1 The bacterial challenge (number and kinds of microorganisms) that the package will encounter in its distribution and use. This may be influenced by factors such as shipping methods, expected shelf life, geographic location, and storage conditions.

5.1.2 The package design, including factors such as adhesion between materials, the presence or absence of secondary and tertiary packaging, and the nature of the device within the package.

5.1.3 The rate and volume exchange of air that the porous package encounters during its distribution and shelf life. This can be influenced by factors including the free-air volume within the package and pressure changes occurring as a result of transportation, manipulation, weather, or mechanical influences (such as room door closures and HVAC systems).

5.1.4 The microstructure of a porous material which influences the relative ability to adsorb or entrap microorganisms, or both, under different air-flow conditions.

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)

This document comes with our free Notification Service, good for the life of the document.

This document is available in either Paper or PDF format.

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