ASTM D4196-05(2019)
(Test Method)Standard Test Method for Confirming the Sterility of Membrane Filters
Standard Test Method for Confirming the Sterility of Membrane Filters
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.
SCOPE
1.1 This test method describes a test to confirm the sterility of either manufacturer presterilized or user-sterilized analytical membrane filters.
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.3 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
General Information
Relations
Standards Content (Sample)
This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: D4196 −05 (Reapproved 2019)
Standard Test Method for
Confirming the Sterility of Membrane Filters
This standard is issued under the fixed designation D4196; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 4. Summary of Test Method
1.1 This test method describes a test to confirm the sterility 4.1 The membrane filters are immersed in sterile culture
media and incubated at temperatures that are suitable for
of either manufacturer presterilized or user-sterilized analytical
membrane filters. growth of viable bacteria, fungi, and yeasts. Growth of
organisms is evidence that the filter has failed the test.
1.2 The values stated in SI units are to be regarded as
standard. No other units of measurement are included in this
5. Significance and Use
standard.
5.1 This test method may be employed to check the sterility
1.3 This standard does not purport to address all of the
of commercially procured sterile membrane filters. The test
safety concerns, if any, associated with its use. It is the
also confirms that sterilized filters have not been contaminated.
responsibility of the user of this standard to establish appro-
Additionally, this test may be used to monitor the efficacy of
priate safety, health, and environmental practices and deter-
in-house sterilization procedures. Filter packages that have
mine the applicability of regulatory limitations prior to use.
obvious packaging defects should not be tested because steril-
1.4 This international standard was developed in accor-
ity may have been compromised.
dance with internationally recognized principles on standard-
6. Reagents and Materials
ization established in the Decision on Principles for the
6.1 Purity of Water—Unless otherwise indicated, reference
Development of International Standards, Guides and Recom-
to water shall be understood to mean Type II reagent grade
mendations issued by the World Trade Organization Technical
water in accordance with Specification D1193.
Barriers to Trade (TBT) Committee.
6.2 Media—Use commercially available dehydrated media.
2. Referenced Documents
Dissolve and sterilize by autoclaving, in accordance with the
manufacturer’s directions.
2.1 ASTM Standards:
D1129 Terminology Relating to Water 6.2.1 Fluid Thioglycollate Medium (Note)—Dispense
40-mL aliquots into suitable-sized vessels with screw-cap
D1193 Specification for Reagent Water
closure,providingaratioofsurfaceareatodepthofmediumso
2.2 Other Standard:
that no more than the upper half of the medium has initially
The United States Pharmacopeia Current Edition (Sections
undergone a color change indicative of oxygen uptake. When
on Sterilization and Sterility Testing)
readyforuse,notmorethantheupperone-tenthofthemedium
should be pink. The medium may be restored once by heating
3. Terminology
infree-flowingsteamuntilthepinkcolordisappears.ThepHof
3.1 Definitions:
the medium, after autoclaving, should be 7.1 6 0.2.
3.1.1 For definitions of terms used in this standard, refer to
NOTE 1—If stored at 2 to 5°C in sealed containers, the media may be
Terminology D1129.
used for 1 year provided they are tested for the growth-promoting
properties every 3 months.
6.2.2 Soybean-Casein Digest Medium (Note)—Dispense
This test method is under the jurisdiction of ASTM Committee D19 on Water
and is the direct responsibility of Subcommittee D19.08 on Membranes and Ion 40-mL aliquots into suitable vessels with screw-cap closure.
Exchange Materials.
The pH after autoclaving should be 7.3 6 0.2.
Current edition approved Nov. 1, 2019. Published January 2020. Originally
6.2.3 Perform a sterility test on each lot of autoclaved
approved in 1982. Last previous edition approved in 2011 as D4196 – 05 (2011).
medium by incubating ten representative containers of each
DOI: 10.1520/D4196-05R19.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
medium, for not less than 10 days, at the specified test
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
temperature.
Standards volume information, refer to the standard’s Document Summary page on
6.2.4 Perform a growth-promotion test, as described below,
the ASTM website.
Mack Publishing Co., Easton, PA 18042.
on each lot of autoclaved medium.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
D4196 − 05 (2019)
6.2.4.1 Inoculate duplicate test containers o
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