Astm D 4196 – 82 (Reapproved 1998) pdf free download

Standard Test Method for
Confirming the Sterility of Membrane Filters1

This standard is issued under the fixed designation D 4196; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of the last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.

1. Scope

1.1 This test method describes a test to confirm the sterility
of either manufacturer sterilized or user-sterilized analytical
membrane filters.

1.2 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.

2. Referenced Documents

2.1 ASTM Standards:
D 1129 Terminology Relating to Water2
D 1193 Specification for Reagent Water2

2.2 Other Standard:
The United States Pharmacopeia, Current Edition3 (Sections on Sterilization and Sterility Testing)

3. Terminology

3.1 Definitions—For definitions of terms used in this test
method, refer to Terminology D 1129.

4. Summary of Test Method

4.1 The membrane filters are immersed in sterile culture
media and incubated at temperatures that are suitable for
the growth of viable bacteria, fungi, and yeasts. The growth of
organisms is evidence that the filter has failed the test.

5. Significance and Use

5.1 This test method may be employed to check the sterility
of commercially procured sterile membrane filters. The test
also confirms that sterilized filters have not been contaminated.
Additionally, this test may be used to monitor the efficacy of
in-house sterilization procedures. Filter packages that have
obvious packaging defects should not be tested because sterility may have been compromised.

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