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ASTM F838-05(2013)

(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 Since all sterilizing filtration processes are performed under positive pressure, this test method is designed to assess the retentivity of a sterilizing filter under process conditions.  
5.1.1 A challenge of 107 bacteria per cm2 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 to provide a high degree of assurance that the filter would quantitatively retain large numbers of organisms. This concept is important, in view of the requirement to provide a quantitative assessment in validating a sterilization process.  
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. This value, coupled with a knowledge of the number and types of organisms (bioburden) indigenous to the process, may then be utilized to determine the probability of obtaining a sterile filtrate. Conversely, the numerical value of the filtration efficiency may be used when one must meet a specified probability of sterility assurance to calculate the volume of fluid that may be filtered in order to maintain that level of assurance.
SCOPE
1.1 This test method determines the bacterial retention characteristics of membrane filters for liquid filtration using Pseudomonas diminuta as the challenge organism. This test method may be employed to evaluate any membrane filter system used for liquid sterilization.  
1.2 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.

General Information

Status
Historical
Publication Date
31-May-2013
ICS
07.100.20 - Microbiology of water
Technical Committee
E55 - Manufacture of Pharmaceutical and Biopharmaceutical Products
Drafting Committee
E55.03 - General Pharmaceutical Standards
Current Stage
Ref Project

Relations

Replaces
ASTM F838-05 - Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration
Effective Date
01-Jun-2013
Replaced By
ASTM F838-15 - Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration
Effective Date
01-May-2015
Referred By
ASTM D8422-21 - Standard Practice for Pre-Stressing Terminal Point-of-Use Water Filters before Testing by Test Method F838
Effective Date
01-Jun-2013

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ASTM F838-05(2013) - Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid FiltrationASTM F838-05(2013) - Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration
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ASTM F838-05(2013) - Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F838 − 05(Reapproved 2013)
Standard Test 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 filer disc which is subsequently incubated on a solidified
growth medium. Organisms that are not retained by the filter
1.1 This test method determines the bacterial retention
being tested will develop into visible colonies on the analysis
characteristics of membrane filters for liquid filtration using
membrane and can then be enumerated.
Pseudomonas diminuta as the challenge organism. This test
method may be employed to evaluate any membrane filter
5. Significance and Use
system used for liquid sterilization.
5.1 Since all sterilizing filtration processes are performed
1.2 This standard may involve hazardous materials,
under positive pressure, this test method is designed to assess
operations, and equipment. This standard does not purport to
the retentivity of a sterilizing filter under process conditions.
address all of the safety concerns, if any, associated with its 7 2
5.1.1 A challenge of 10 bacteria per cm of effective
use. It is the responsibility of the user of this standard to
filtration area is orders of magnitude higher than one would
establish appropriate safety and health practices and deter-
expecttoencounterinasterilizingfiltrationprocess.Thislevel
mine the applicability of regulatory limitations prior to use.
wasselectedinordertoprovideahighdegreeofassurancethat
the filter would quantitatively retain large numbers of organ-
2. Referenced Documents
isms. This concept is important, in view of the requirement to
2
2.1 ASTM Standards:
provide a quantitative assessment in validating a sterilization
D1193Specification for Reagent Water
process.
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. This value, coupled
3.1.1 log reduction value—the logarithm to the base 10 of
with a knowledge of the number and types of organisms
the ratio of the number of microorganisms in the challenge to
(bioburden) indigenous to the process, may then be utilized to
the number of organisms in the filtrate.
determine the probability of obtaining a sterile filtrate.
Conversely,thenumericalvalueofthefiltrationefficiencymay
4. Summary of Test Method
be used when one must meet a specified probability of sterility
4.1 After sterilization, the test filter is challenged with a
assurance to calculate the volume of fluid that may be filtered
3
suspension of Pseudomonas diminuta (ATCC 19146) at a
in order to maintain that level of assurance.
7 2
concentration of 10 organisms per cm of effective filtration
6. Apparatus
area (EFA) at a maximum differential pressure across the test
filterof30psig(206kPa)andaflowrateof0.5to1.0GPMper
6.1 Assemble the apparatus described below as in Fig. 1:
2 -3 2
ft of effective filtration area (2 to4×10 LPM per cm ).The
6.1.1 Stainless Steel Pressure Vessel, 12-L capacity (or
entire filtrate is then filtered through an analytical membrane
larger), fitted witha0to 50-psi (0 to 350-kPa) pressure gage.
6.1.2 Air Regulator.
6.1.3 142-mm Disc Filter Assemblies, two or more, with
1
This test method is under the jurisdiction of ASTM Committee E55 on
hose connections.
ManufactureofPharmaceuticalProductsandisthedirectresponsibilityofSubcom-
mittee E55.03 on General Pharmaceutical Standards.
6.1.4 Diaphragm-Protected 0 to 50-psi Pressure Gage (0 to
Current edition approved June 1, 2013. Published June 2013. Originally
350-kPa), for upstream pressure reading. A second equivalent
approved in 1983. Last previous edition published in 2005 as F838–05. DOI:
gauge for downstream pressure reading is optional.
10.1520/F0838-05R13.
2
6.1.5 Manifold,withvalves(autoclavable)andhoseconnec-
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
tions.
Standards volume information, refer to the standard’s Document Summary page on
6.1.6 Autoclavable Tubing, (must be able to withstand a
the ASTM website.
3
pressure of 50 psi (350 kPa)).
Available from American Type Culture Collection (ATCC), 10801 University
Boulevard, Manassas, VA 20110, http://www.atcc.org. 6.1.7 Filter Housing, with hose connections.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F838 − 05 (2013
...

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Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration

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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 method has sufficient sensitivity to detect oversized pores and that the filter 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.  
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Standard Test Method for Retention Characteristics of 0.40 to 0.45 μm Membrane Filters Used in Routine Filtration Procedures for the Evaluation of Microbiological Water Quality

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5.1 Microbiological water testing procedures using membrane filtration are based on the premise that all bacteria within a specific size range will be retained by the membrane filter used. If the membrane filter does not retain these bacteria, false negative results or lowered density estimates may occur that could have serious repercussions due to the presence of unrecognized potential health hazards in the water being tested, especially in drinking water.  
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SCOPE
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1.2 The procedures described are for the use of user laboratories as differentiated from manufacturers’ laboratories.  
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Standard Guide for Conducting Static Toxicity Tests with Microalgae

SIGNIFICANCE AND USE
5.1 Tests with algae provide information on the toxicity of test materials to an important component of the aquatic biota and might indicate whether additional testing (2) is desirable. Specific testing procedures under various regulatory jurisdictions follow procedures similar to those described in this Guide (3, 4). Users should consult with any specific regulatory requirements to determine the applicability and consistency of this standard with such requirements.  
5.2 Algae are ubiquitous in aquatic ecosystems, where they incorporate solar energy into biomass, produce oxygen, function in nutrient cycling and serve as food for animals. Because of their ecological importance, sensitivity to many toxicants, ready availability, ease of culture, and fast growth rates (rendering it possible to conduct a multi-generation test in a short period of time), algae are often used in toxicity testing.  
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5.4 Results of algal toxicity tests might be an important consideration when assessing the hazards of materials to aquatic organisms (See Guide E1023) or deriving water quality criteria for aquatic organisms (5).  
5.5 Results of algal toxicity tests might be useful for studying biological availability of, and structure-activity relationships between, test materials.  
5.6 Results of algal toxicity tests will depend on the temperature, composition of the growth medium, and other factors. These tests are conducted in solutions that contain concentrations of salts, minerals, and nutrients that greatly exceed those in most surface waters. These conditions may over- or under-estimate the effects of the test material if discharged to surface waters.
SCOPE
1.1 This guide covers procedures for obtaining laboratory data concerning the adverse effects of a test material added to growth medium on growth of certain species of freshwater and saltwater microalgae during a static exposure. These procedures will probably be useful for conducting short-term toxicity tests with other species of algae, although modifications might be necessary. Although the test duration is comparable to an acute toxicity test with aquatic animals, an algal toxicity test of short duration (72, 96 or 120 h) allows for examination of effects upon multiple generations of an algal population and thus should not be viewed as an acute toxicity test.  
1.2 Other modifications of these procedures might be justified by special needs or circumstances. Although using appropriate procedures is more important than following prescribed procedures, results of tests conducted using unusual procedures are not likely to be comparable to results of many other tests. Comparison of results obtained using modified and unmodified versions of these procedures might provide useful information concerning new concepts and procedures for conducting toxicity tests with microalgae.  
1.3 These procedures are applicable to many chemicals, either individually or in formulations, commercial products, or known mixtures. With appropriate modifications, these procedures can be used to conduct tests on temperature, and pH and on such materials as aqueous effluents (see Guide E1192), leachates, oils, particulate matter, sediments, and surface waters. Static tests might not be applicable to materials that are highly volatile, are rapidly biologically or chemically transformed in aqueous solutions, or are removed from test solutions in substantial quantities by the test vessels or organisms during the test. (1)3 However, practical flow-through test procedures with microalgae have not been developed.  
1.4 Results of tests using microalgae should usually be reported in terms of the 96-h (or other time period) IC50 (see 3.2.5) b...

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ASTM
ASTM E1563-21a(Guide)
Standard Guide for Conducting Short-Term Chronic Toxicity Tests with Echinoid Embryos

SIGNIFICANCE AND USE
5.1 An acute toxicity test is conducted to assess effects of a short-term exposure of organisms to a test material under specific experimental conditions. An acute toxicity test does not provide information concerning whether delayed effects will occur and typically evaluates effects on survival. A chronic test is typically longer in duration and includes a sublethal endpoint to assess effects on a population that might occur beyond the exposure period. Because the echinoderm embryo development test includes a sublethal endpoint, but is also short in duration, these tests are considered to be short-term chronic tests, consistent with EPA guidance.  
5.2 Because embryos and larvae are usually assumed to be the most sensitive life stages of these echinoid species, and because some of these species are commercially and recreationally important, the results of these tests are often considered to be a good indication of the acceptability of pollutant concentrations to saltwater species in general. The results of these toxicity tests are often assumed to be an important consideration when assessing the hazard of materials to other saltwater organisms (see Guides E724 and E1023) or when deriving water quality criteria for saltwater organisms  (7).  
5.3 The results of short-term chronic toxicity tests might be used to predict effects likely to occur to aquatic organisms in field situations as a result of exposure under comparable conditions, except that toxicity to benthic species might depend on sorption or settling of the test material onto the substrate.  
5.4 The results of short-term chronic tests might be used to compare the sensitivities of different species and the acute toxicities of different test materials, and to determine the effects of various environmental factors on the results of such tests.  
5.5 The results of short-term chronic toxicity tests might be useful for studying the biological availability of, and structure-activity relationships between, t...
SCOPE
1.1 This guide covers procedures for obtaining laboratory data concerning the short-term chronic effects of a test material on echinoderm embryos and the resulting larvae (sea urchins and sand dollars) during static 48- to 96-h exposures. These procedures have generally been used with U.S. East Coast (Arbacia punctulata and  Strongylocentrotus droebachiensis ) (1)3 and West Coast species (Strongylocentrotus purpuratus, S. droebachiensis, and Dendraster excentricus) (2). The basic procedures described in this guide first originated in Japan and Scandanavia  (3), and parallel procedures have been used with foreign species, especially in Japan and the Mediterranean  (4). These procedures will probably be useful for conducting static toxicity tests with embryos of other echinoid species, although modifications might be necessary.  
1.2 Other modifications of these procedures might be justified by special needs or circumstances. Although using procedures appropriate to a particular species or special needs and circumstances is more important than following prescribed procedures, the results of tests conducted by using unusual procedures are not likely to be comparable with those of many other tests. The comparison of results obtained by using modified and unmodified versions of these procedures might provide useful information concerning new concepts and procedures for conducting tests starting with embryos of echinoids.  
1.3 These procedures are applicable to most chemicals, either individually or in formulations, commercial products, or known mixtures. With appropriate modifications, these procedures can be used to conduct tests on temperature, dissolved oxygen, and pH and on such materials as aqueous effluents (see also Guide E1192), leachates, oils, particulate matter, surface waters, effluents, and sediments (Annex A1). Renewal tests might be preferable to static tests for materials that have a high oxygen demand, are...

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  • Guide
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    English language
    sale 15% off