ASTM D4196-05(2011)
(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
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 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. ^
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Standards Content (Sample)
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Designation:D4196 −05 (Reapproved 2011)
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 growth of viable bacteria, fungi, and yeasts. Growth of
organisms is evidence that the filter has failed the test.
1.1 This test method describes a test to confirm the sterility
of either manufacturer presterilized or user-sterilized analytical
5. Significance and Use
membrane filters.
5.1 This test method may be employed to check the sterility
1.2 The values stated in SI units are to be regarded as
of commercially procured sterile membrane filters. The test
standard. No other units of measurement are included in this
also confirms that sterilized filters have not been contaminated.
standard.
Additionally, this test may be used to monitor the efficacy of
in-house sterilization procedures. Filter packages that have
1.3 This standard does not purport to address all of the
obvious packaging defects should not be tested because steril-
safety concerns, if any, associated with its use. It is the
ity may have been compromised.
responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica-
6. Reagents and Materials
bility of regulatory limitations prior to use.
6.1 Purity of Water—Unless otherwise indicated, reference
to water shall be understood to mean Type II reagent grade
2. Referenced Documents
2 water in accordance with Specification D1193.
2.1 ASTM Standards:
6.2 Media—Use commercially available dehydrated media.
D1129 Terminology Relating to Water
Dissolve and sterilize by autoclaving, in accordance with the
D1193 Specification for Reagent Water
manufacturer’s directions.
2.2 Other Standard:
6.2.1 Fluid Thioglycollate Medium (Note)—Dispense
The United States Pharmacopeia, Current Edition (Sec-
40-mL aliquots into suitable-sized vessels with screw-cap
tions on Sterilization and Sterility Testing)
closure,providingaratioofsurfaceareatodepthofmediumso
that no more than the upper half of the medium has initially
3. Terminology
undergone a color change indicative of oxygen uptake. When
3.1 Definitions—For definitions of terms used in this test
ready for use, not more than the upper one tenth of the medium
method, refer to Terminology D1129.
should be pink. The medium may be restored once by heating
infree-flowingsteamuntilthepinkcolordisappears.ThepHof
4. Summary of Test Method
the medium, after autoclaving, should be 7.1 6 0.2.
4.1 The membrane filters are immersed in sterile culture
NOTE 1—If stored at 2 to 5°C in sealed containers, the media may be
media and incubated at temperatures that are suitable for
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 May 1, 2011. Published June 2011. Originally
6.2.3 Perform a sterility test on each lot of autoclaved
approved in 1982. Last previous edition approved in 2005 as D4196 – 05. DOI:
medium by incubating ten representative containers of each
10.1520/D4196-05R11.
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 (2011)
6.2.4.1 Inoculate duplicate test containers of each medium 7.6 Incubate the soybean-casein digest medium at 20 to
separately with less than 100 of each of the below listed 25°C for 14 days.
microorganisms. Incubate 7 days at the temperatures listed
7.7 Examine all containers for the growth of micr
...
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