ASTM F838-15
(Test Method)Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration
Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration
SIGNIFICANCE AND USE
5.1 This test method is designed to assess the retentivity of a sterilizing filter under standard challenge conditions.
5.1.1 A challenge of 107 bacteria per cm2 of effective filtration area is selected to provide a high degree of assurance that the filter will be challenged uniformly across the membrane surface to assure it will quantitatively retain large numbers of organisms. The model challenge organism, B. diminuta, is widely considered to be a small bacterium and is recognized as an industry standard for qualifying sterilizing filters. Other species may represent a worst-case test in terms of ability to penetrate a filter. This test does not provide assurance that filters can completely retain such bacteria.
5.1.2 The analytical procedure utilized in this test method provides a method to assign a numerical value to the filtration efficiency of the filter being evaluated under standard filtration conditions. For the purpose of product sterility assurance, additional process-specific studies should be performed.
SCOPE
1.1 This test method determines the bacterial retention characteristics of membrane filters for liquid filtration using Brevundimonas diminuta as the challenge organism. This test method may be employed to evaluate any membrane filter system used for liquid sterilization.
1.2 This test method is not intended to be used in performance of product- and process-specific validation of the bacterial retention characteristics of membrane filters to be used in pharmaceutical or biopharmaceutical sterilizing filtration, or both. Process- and product-specific bacterial retention validation should be carried out using the intended product manufacturing process parameters and the product solution or surrogate as the carrier fluid.
1.3 The values stated in SI units are to be regarded as standard.
1.3.1 Exception—The inch-pound values given for units of pressure are to be regarded as standard; SI unit conversions are shown in parentheses.
1.4 This standard may involve hazardous materials, operations, and equipment. 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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Designation: F838 − 15
StandardTest Method for
Determining Bacterial Retention of Membrane Filters
1
Utilized for Liquid Filtration
ThisstandardisissuedunderthefixeddesignationF838;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 3.1.1 log reduction value—the logarithm to the base 10 of
the ratio of the number of microorganisms in the challenge to
1.1 This test method determines the bacterial retention
the number of organisms in the filtrate.
characteristics of membrane filters for liquid filtration using
Brevundimonas diminuta as the challenge organism. This test
4. Summary of Test Method
method may be employed to evaluate any membrane filter
system used for liquid sterilization. 4.1 After sterilization, the test filter is challenged with a
3
suspensionof B. diminuta(ATCC19146 )ataconcentrationof
1.2 This test method is not intended to be used in perfor-
7 2
10 organisms per cm of effective filtration area (EFA) at a
mance of product- and process-specific validation of the
maximum differential pressure across the test filter of 30 psig
bacterial retention characteristics of membrane filters to be
–3 2
(206 kPa) and a flow rate of 2 to4×10 LPM per cm of
used in pharmaceutical or biopharmaceutical sterilizing
effective filtration area. The entire filtrate is then filtered
filtration, or both. Process- and product-specific bacterial
through an analytical membrane filer disc, which is subse-
retention validation should be carried out using the intended
quentlyincubatedonasolidifiedgrowthmedium.Microorgan-
product manufacturing process parameters and the product
ismsthatarenotretainedbythefilterbeingtestedwilldevelop
solution or surrogate as the carrier fluid.
intovisiblecoloniesontheanalysismembraneandcanthenbe
1.3 The values stated in SI units are to be regarded as
enumerated.
standard.
1.3.1 Exception—The inch-pound values given for units of
5. Significance and Use
pressurearetoberegardedasstandard;SIunitconversionsare
5.1 This test method is designed to assess the retentivity of
shown in parentheses.
a sterilizing filter under standard challenge conditions.
1.4 This standard may involve hazardous materials, 7 2
5.1.1 A challenge of 10 bacteria per cm of effective
operations, and equipment. This standard does not purport to
filtration area is selected to provide a high degree of assurance
address all of the safety concerns, if any, associated with its
that the filter will be challenged uniformly across the mem-
use. It is the responsibility of the user of this standard to
brane surface to assure it will quantitatively retain large
establish appropriate safety and health practices and deter-
numbers of organisms. The model challenge organism, B.
mine the applicability of regulatory limitations prior to use.
diminuta, is widely considered to be a small bacterium and is
recognized as an industry standard for qualifying sterilizing
2. Referenced Documents
filters. Other species may represent a worst-case test in terms
2
2.1 ASTM Standards:
of ability to penetrate a filter. This test does not provide
D1193Specification for Reagent Water
assurance that filters can completely retain such bacteria.
5.1.2 The analytical procedure utilized in this test method
3. Terminology
provides a method to assign a numerical value to the filtration
3.1 Definitions:
efficiency of the filter being evaluated under standard filtration
conditions. For the purpose of product sterility assurance,
1 additional process-specific studies should be performed.
This test method is under the jurisdiction of ASTM Committee E55 on
ManufactureofPharmaceuticalProductsandisthedirectresponsibilityofSubcom-
mittee E55.03 on General Pharmaceutical Standards.
6. Apparatus
Current edition approved May 1, 2015. Published May 2015. Originally
approved in 1983. Last previous edition published in 2013 as F838–05 (2013). 6.1 Assemble the apparatus described below as in Fig. 1:
DOI: 10.1520/F0838-15.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
3
Standards volume information, refer to the standard’s Document Summary page on Available from American Type Culture Collection (ATCC), 10801 University
the ASTM website. Boulevard, Manassas, VA 20110, http://www.atcc.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F838 − 15
FIG. 1 Test Set-Up for Bacteria Retention Testing
6.1.1 Stainless Steel Pressure Vessel, 12-L capacity (or fied in the current edition of Standard Methods for the
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F838 − 05 (Reapproved 2013) F838 − 15
Standard Test Method for
Determining Bacterial Retention of Membrane Filters
1
Utilized for Liquid Filtration
This standard is issued under the fixed designation F838; 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
1.1 This test method determines the bacterial retention characteristics of membrane filters for liquid filtration using
PseudomonasBrevundimonas diminuta as the challenge organism. This test method may be employed to evaluate any membrane
filter system used for liquid sterilization.
1.2 This test method is not intended to be used in performance of product- and process-specific validation of the bacterial
retention characteristics of membrane filters to be used in pharmaceutical or biopharmaceutical sterilizing filtration, or both.
Process- and product-specific bacterial retention validation should be carried out using the intended product manufacturing process
parameters and the product solution or surrogate as the carrier fluid.
1.3 The values stated in SI units are to be regarded as standard.
1.3.1 Exception—The inch-pound values given for units of pressure are to be regarded as standard; SI unit conversions are
shown in parentheses.
1.4 This standard may involve hazardous materials, operations, and equipment. 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
2.1 ASTM Standards:
D1193 Specification for Reagent Water
3. Terminology
3.1 Definitions:
3.1.1 log reduction value—the logarithm to the base 10 of the ratio of the number of microorganisms in the challenge to the
number of organisms in the filtrate.
4. Summary of Test Method
3
4.1 After sterilization, the test filter is challenged with a suspension of PseudomonasB. diminuta (ATCC 19146)19146 ) at a
7 2
concentration of 10 organisms per cm of effective filtration area (EFA) at a maximum differential pressure across the test filter
2 -3–3 2
of 30 psig (206 kPa) and a flow rate of 0.5 to 1.0 GPM per ft2 to of effective filtration area (2 to 4 × 10 LPM per cm ). of
effective filtration area. The entire filtrate is then filtered through an analytical membrane filer disc, which is subsequently
incubated on a solidified growth medium. OrganismsMicroorganisms that are not retained by the filter being tested will develop
into visible colonies on the analysis membrane and can then be enumerated.
5. Significance and Use
5.1 Since all sterilizing filtration processes are performed under positive pressure, this This test method is designed to assess
the retentivity of a sterilizing filter under process standard challenge conditions.
1
This test method is under the jurisdiction of ASTM Committee E55 on Manufacture of Pharmaceutical Products and is the direct responsibility of Subcommittee E55.03
on General Pharmaceutical Standards.
Current edition approved June 1, 2013May 1, 2015. Published June 2013May 2015. Originally approved in 1983. Last previous edition published in 20052013 as
F838 – 05.F838 – 05 (2013). DOI: 10.1520/F0838-05R13.10.1520/F0838-15.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Available from American Type Culture Collection (ATCC), 10801 University Boulevard, Manassas, VA 20110, http://www.atcc.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F838 − 15
7 2
5.1.1 A challenge of 10 bacteria per cm of effective filtration area is orders of magnitude higher than one would expect to
encounter in a sterilizing filtration process. This level was selected in order selected to provide a high degree of assurance that the
filter would will be challenged uniformly across the membrane surface to assure it will quantitatively retain large numbers of
organisms. This concept The model challenge organism, B. diminuta, is important, in view of the requi
...
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