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ASTM E1326-98

(Guide)

Standard Guide for Evaluating Nonconventional Microbiological Tests Used for Enumerating Bacteria

Standard Guide for Evaluating Nonconventional Microbiological Tests Used for Enumerating Bacteria

SCOPE
1.1 The purpose of this guide is to assist users and producers of nonconventional tests in determining the applicability of the test for processing different types of samples and evaluating the accuracy of the results. Conventional procedures such as the Heterotrophic (Standard) Plate Count, the Most Probable Number (MPN) method and the Spread Plate are widely cited and accepted for the enumeration of microorganisms. However, these methods have their limitations, such as performance time and degree of accuracy. It is these limitations that have recently led to the marketing of a variety of non-conventional procedures, test kits and instruments.
1.2 A conventional test is one that is widely accepted and published as a standard microbiological method or related procedure. A new, nonconventional test method will attempt to provide the same information through the measurement of a different parameter. This guide is designed for comparing levels of bacteria recovered from samples by the Heterotrophic Plate Count Procedure to the equivalent units determined with a nonconventional test.
1.3 It is recognized that the Heterotrophic Plate Count does not recover all microorganisms present in a product or a system  (1). When this problem occurs during the characterization of a microbiological population, alternate standard enumeration procedures may be necessary, as in the case of sulfate-reducing bacteria. At other times, chemical methods that measure the rates of appearance of metabolic derivatives or the utilization of contaminated product components might be indicated. In evaluating nonconventional tests, the use of these alternate standard procedures may be the only means available for establishing correlation. In such cases, this guide can serve as a reference for those considerations.
1.4 Since there are so many types of tests that could be considered nonconventional, it is impossible to recommend a specific test protocol with statistical analyses for evaluating the tests. Instead, this guide should assist in determining what types of tests should be considered to verify the utility and identify the limitations of the nonconventional test.

General Information

Status
Historical
Publication Date
09-Oct-1998
ICS
07.100.10 - Medical microbiology
Technical Committee
E35 - Pesticides, Antimicrobials, and Alternative Control Agents
Drafting Committee
E35.15 - Antimicrobial Agents
Current Stage
Ref Project

Relations

Replaced By
ASTM E1326-06 - Standard Guide for Evaluating Nonconventional Microbiological Tests Used for Enumerating Bacteria
Effective Date
01-Nov-2006
Referred By
ASTM E1259-23 - Standard Practice for Evaluation of Antimicrobials in Liquid Fuels Boiling Below 390 °C
Effective Date
10-Oct-1998
Referred By
ASTM E723-13(2019) - Standard Practice for Evaluation of Antimicrobials as Preservatives for Aqueous-Based Products Used in the Paper Industry (Bacterial Spoilage)
Effective Date
10-Oct-1998
Referred By
ASTM D6974-20 - Standard Practice for Enumeration of Viable Bacteria and Fungi in Liquid Fuels—Filtration and Culture Procedures
Effective Date
10-Oct-1998
Referred By
ASTM E2694-21 - Standard Test Method for Measurement of Adenosine Triphosphate in Water-Miscible Metalworking Fluids
Effective Date
10-Oct-1998
Referred By
ASTM E645-18 - Standard Practice for Evaluation of Microbicides Used in Cooling Water Systems
Effective Date
10-Oct-1998
Referred By
ASTM D6469-20 - Standard Guide for Microbial Contamination in Fuels and Fuel Systems
Effective Date
10-Oct-1998
Referred By
ASTM E2275-19 - Standard Practice for Evaluating Water-Miscible Metalworking Fluid Bioresistance and Antimicrobial Pesticide Performance
Effective Date
10-Oct-1998
Referred By
ASTM D8070-23 - Standard Test Method for Screening of Fuels and Fuel Associated Aqueous Specimens for Microbial Contamination by Lateral Flow Immunoassay
Effective Date
10-Oct-1998
Referred By
ASTM D7847-22 - Standard Guide for Interlaboratory Studies for Microbiological Test Methods
Effective Date
10-Oct-1998
Referred By
ASTM D8506-23 - Standard Guide for Microbial Contamination and Biodeterioration in Turbine Oils and Turbine Oil Systems
Effective Date
10-Oct-1998
Referred By
ASTM E3152-23 - Standard Guide for Standard Test Methods and Practices Available for Determining Antifungal Activity on Natural or Synthetic Substrates Treated with Antimicrobial Agents
Effective Date
10-Oct-1998
Referred By
ASTM E979-20 - Standard Practice for Evaluation of Antimicrobial Agents as Preservatives for Invert Emulsion and Other Water Containing Hydraulic Fluids
Effective Date
10-Oct-1998
Referred By
ASTM E2169-22 - Standard Practice for Selecting Antimicrobial Pesticides for Use in Water-Miscible Metalworking Fluids
Effective Date
10-Oct-1998
Referred By
ASTM E2563-18 - Standard Practice for Enumeration of Non-Tuberculosis <emph type="bdit">Mycobacteria</emph > in Aqueous Metalworking Fluids by Plate Count Method
Effective Date
10-Oct-1998

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ASTM E1326-98 - Standard Guide for Evaluating Nonconventional Microbiological Tests Used for Enumerating BacteriaASTM E1326-98 - Standard Guide for Evaluating Nonconventional Microbiological Tests Used for Enumerating Bacteria
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ASTM E1326-98 - Standard Guide for Evaluating Nonconventional Microbiological Tests Used for Enumerating Bacteria
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Standards Content (Sample)

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:E 1326–98
Standard Guide for
Evaluating Nonconventional Microbiological Tests Used for
1
Enumerating Bacteria
This standard is issued under the fixed designation E 1326; 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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope types of tests should be considered to verify the utility and
identify the limitations of the nonconventional test.
1.1 Thepurposeofthisguideistoassistusersandproducers
of nonconventional tests in determining the applicability of the
2. Referenced Documents
testforprocessingdifferenttypesofsamplesandevaluatingthe
3
2.1 ASTM Standards:
accuracy of the results. Conventional procedures such as the
D 3870 Practice for Establishing Performance Characteris-
Heterotrophic (Standard) Plate Count, the Most Probable
tics for Colony Counting Methods in Bacteriology
Number (MPN) method and the Spread Plate are widely cited
D 5245 Practice for Cleaning Laboratory Glassware, Plas-
and accepted for the enumeration of microorganisms. How-
ticware and Equipment used in Microbiological Analysis
ever,thesemethodshavetheirlimitations,suchasperformance
D 5465 Practice for Determining Microbial Counts From
time and degree of accuracy. It is these limitations that have
Waters Analyzed by Plating Methods
recently led to the marketing of a variety of non-conventional
E 691 Practice for Conducting an Interlaboratory Study to
procedures, test kits and instruments.
Determine the Precision of a Test Method
1.2 A conventional test is one that is widely accepted and
published as a standard microbiological method or related
3. Summary of Guide
procedure.Anew, nonconventional test method will attempt to
3.1 ASTM standard practices are referenced for use by
provide the same information through the measurement of a
producers and users to determine the potential utility of the
different parameter. This guide is designed for comparing
nonconventional test. Users of tests who are unequipped for
levels of bacteria recovered from samples by the Heterotrophic
performing standard microbiological tests are given recom-
Plate Count Procedure to the equivalent units determined with
mendations for seeking out microbiological laboratories that
a nonconventional test.
could perform collaborative studies to evaluate and verify the
1.3 It is recognized that the Heterotrophic Plate Count does
information generated with the nonconventional tests.
not recover all microorganisms present in a product or a
2
system (1). When this problem occurs during the character-
4. Significance and Use
ization of a microbiological population, alternate standard
4.1 This guide should be used by producers and potential
enumeration procedures may be necessary, as in the case of
producers of nonconventional tests to determine the accuracy,
sulfate-reducing bacteria. At other times, chemical methods
selectivity, specificity, and reproducibility of the tests, as
that measure the rates of appearance of metabolic derivatives
defined in Practices E 691 and D 3870. Results of such studies
or the utilization of contaminated product components might
should identify the limitations and indicate the utility or
be indicated. In evaluating nonconventional tests, the use of
applicability of the nonconventional test, or both, for use on
these alternate standard procedures may be the only means
different types of samples.
available for establishing correlation. In such cases, this guide
4.2 Nonconventional test users and potential users should
can serve as a reference for those considerations.
employ this guide to evaluate results of the nonconventional
1.4 Since there are so many types of tests that could be
testascomparedtotheirpresentmethods.PracticesD 5245–92
considered nonconventional, it is impossible to recommend a
and D 5465–93 should be reviewed in regards to the conven-
specific test protocol with statistical analyses for evaluating the
tional microbiological methods employed. If conventional
tests. Instead, this guide should assist in determining what
methods have not been used for monitoring the systems, then
guidelines are included for obtaining microbiological exper-
tise.
1
This guide is under the jurisdiction ofASTM Committee E35 on Pesticides and
is the direct responsibility of Subcommittee E35.15 on Antimicrobial Agents.
3
Current edition approved Oct. 10, 1998. Published December 1998. Originally For referenced ASTM standards, visit the ASTM website, www.astm.org, or
published as E 1326 – 90. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
2
The boldface numbers in parentheses refer to the list of references
...

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5.1 This guide should be used by producers and potential producers of non-culture tests to determine the accuracy, selectivity, specificity, and precision of the tests, as defined in Practice E691. Results of such studies should identify the limitations and indicate the utility or applicability of the non-culture test, or both, for use on different types of samples. Guide E1488 recommends other statistical tools for evaluating the suitability and applicability of proposed new test methods.  
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1.1 The purpose of this guide is to assist users and producers of non-culture microbiological tests in determining the applicability of the test for processing different types of samples and evaluating the accuracy of the results. Culture test procedures such as the Heterotrophic (Standard) Plate Count, the Most Probable Number (MPN) method and the Spread Plate Count are widely cited and accepted for the enumeration of microorganisms. However, these methods have their limitations, such as performance time. Moreover, any given culture test method typically recovers only a portion of the total viable microbes present in a sample. It is these limitations that have recently led to the marketing of a variety of non-culture procedures, test kits and instruments.  
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4.1 Single-use systems (SUSs) used for biopharmaceutical manufacturing must maintain sterility and product quality of the fluid inside. Such articles or systems should therefore be validated as providing an effective barrier against microbial ingress. The microbial barrier properties of a SUS may be demonstrated using deterministic physical tests that have been correlated to microbial integrity. Such physical test methods are described in Test Method E3336. Two microbial test methods (aerosol exposure and immersion exposure) are described in this test method that can be used to demonstrate microbial integrity of a SUS or determine the MALL, the maximum defect size that does not allow microbial ingress, into a SUS.  
4.2 It is important to note that the results of microbial ingress tests are heavily dependent on the conditions under which the test is performed and are not suitable for routine checking of a SUS due to the test’s destructive nature.  
4.2.1 Any size defect may be forced to fail under sufficiently aggressive conditions (including a large enough sample size, high differential pressure, or high hydrostatic pressure, for example) that would not ordinarily reflect normal use conditions. Thus, it is necessary to clearly define the relevant conditions for a test through a risk assessment of both the actual SUS claims and its final use (Practice E3244). Once that is established, the size of defect that can be detected under those conditions can be determined, if required, using defined defects.  
4.2.2 “Relevant conditions” refers to worse-case actual use conditions but does not mean that a SUS must be tested under theoretically absolute (extreme) “worst-case” conditions.  
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SCOPE
1.1 The microbial test method outlined in this test method applies to microbial ingress risk assessment of a single-use system (SUS) or its individual components that require integrity testing either by the assembly supplier or the end user of the assembly based on a potential risk of a breach to the product or manufacturing process.  
1.2 The aim of microbial ingress testing of sterile SUSs used in biopharmaceutical manufacturing is two-fold:  
1.2.1 Firstly, it is used to evaluate the ability of a SUS fluid path to remain sterile after a SUS has been challenged by microbial exposure. Microbial exposure is achieved either by directly placing a SUS into a container of microbial challenge solution, or by delivering an aerosolized microbial challenge onto a SUS that is placed inside a test chamber designed to generate and deliver the aerosol. The choice of the test challenge organism should be justified based on a risk assessment of the SUS and conditions of use.  
1.2.2 Additionally, microbial ingress testing can be used to determine the maximum allowable leakage limit (MALL) that does not allow microbial ingress under specific test conditions. The defect size that can be detected by specific physical integrity testing methods (see Test Method E3336) can be correlated to this MALL in order to claim microbial integrity. Test articles bearing calibrated defects over a range of dimensions, including up to a defect size expected to consistently allow microbial ingress as a positive control (defect-based positive control), may be tested to determine the MALL.  
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Standard Practice for Quantification of Calcium Deposits in Osteogenic Culture of Progenitor Cells Using Fluorescent Image Analysis

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5.1 In-vitro osteoblast differentiation assays are one approach to screen progenitor stem cells for their capability to become osteoblasts. The extent of calcium deposits or mineralized matrix that form in vitro may be an indicator of differentiation to a functional osteoblast; however, expression of osteogenic genes or proteins is another important measurement to use in conjunction with this assay to determine the presence of an osteoblast.  
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SCOPE
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5.1 The presence of cell growth medium complicates a direct analysis of cells with SIMS. Attempts to wash out the nutrient medium results in the exposure of cells to unphysiological reagents that may also alter their chemical composition. This obstacle is overcome by using a sandwich freeze-fracture method (1). This cryogenic method has provided a unique way of sampling individual cells in their native state for SIMS analysis.  
5.2 The procedure described here has been successfully used for imaging Na+ and K+ ion transport  (3), calcium alterations in stimulated cells (4,5), and localization of therapeutic drugs and isotopically labeled molecules in single cells (6). The frozen freeze-dried cells prepared according to this method have been checked for SIMS matrix effects  (7). Ion image quantification has also been achieved in this sample type (8).  
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1.3 This guide is not suitable for any plastic embedded cell culture specimens.  
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Standard Guide for Evaluating Non-culture Microbiological Tests

SIGNIFICANCE AND USE
5.1 This guide should be used by producers and potential producers of non-culture tests to determine the accuracy, selectivity, specificity, and precision of the tests, as defined in Practice E691. Results of such studies should identify the limitations and indicate the utility or applicability of the non-culture test, or both, for use on different types of samples. Guide E1488 recommends other statistical tools for evaluating the suitability and applicability of proposed new test methods.  
5.2 Non-culture test users and potential users should employ this guide to evaluate results of the non-culture test as compared to their present methods. Practices D5245 and D5465 should be reviewed in regards to the microbiological methods employed. If culture methods have not been used for monitoring the systems, then guidelines are included for obtaining microbiological expertise.  
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5.5 Since many methods based on entirely diff...
SCOPE
1.1 The purpose of this guide is to assist users and producers of non-culture microbiological tests in determining the applicability of the test for processing different types of samples and evaluating the accuracy of the results. Culture test procedures such as the Heterotrophic (Standard) Plate Count, the Most Probable Number (MPN) method and the Spread Plate Count are widely cited and accepted for the enumeration of microorganisms. However, these methods have their limitations, such as performance time. Moreover, any given culture test method typically recovers only a portion of the total viable microbes present in a sample. It is these limitations that have recently led to the marketing of a variety of non-culture procedures, test kits and instruments.  
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SIGNIFICANCE AND USE
4.1 This practice is useful for assessing cytotoxic potential both when evaluating new materials or formulations for possible use in medical applications, and as part of a quality control program for established medical materials and medical devices.  
4.2 This practice assumes that assessment of cytotoxicity potential provides one method for predicting the potential for cytotoxic or necrotic reactions to medical materials and devices during clinical applications to humans. In general, cell culture testing methods have shown good correlation with animal assays when only chemical toxicities are being considered.
Note 1: The results obtained using this method may not predict in vivo behavior which can be influenced by multiple factors such as those arising from site of application or physical properties that may result from design and fabrication.  
4.3 This cell culture test method is suitable for adoption in specifications and standards for materials for use in the construction of medical devices that are intended to have direct contact with tissue, tissue fluids, or blood. However, care should be taken when testing materials that are absorbable, include an eluting or degradable coating, are liquid or gelatinous in nature, are irregularly shaped solid materials, or have a high density or mass, to make sure that the method is applicable. If leachables from the test sample are capable of diffusing through the agar layer, agarose-based methods such as Test Method F895 may be considered as an alternate method, depending on sample characteristics, or in cases where investigators wish to further evaluate the cytotoxic response of cells underlying the test sample.
SCOPE
1.1 This practice covers a reference method of direct contact cell culture testing which may be used in evaluating the cytotoxic potential of materials for use in the construction of medical materials and devices.  
1.2 This practice may be used either directly to evaluate materials or as a reference against which other cytotoxicity test methods may be compared.  
1.3 This is one of a series of reference test methods for the assessment of cytotoxic potential, employing different techniques.  
1.4 Assessment of cytotoxicity is one of several tests employed in determining the biological response to a material, as recommended in Practice F748.  
1.5 The L-929 cell line was chosen because it has a significant history of use in assays of this type. This is not intended to imply that its use is preferred; only that the L-929 is a well characterized, readily available, established cell line that has demonstrated reproducible results in several laboratories.  
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.7 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.  
1.8 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.

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ASTM
ASTM E1968-19(Practice)
Standard Practice for Microcrystal Testing in Forensic Analysis for Cocaine

SIGNIFICANCE AND USE
5.1 This technique involves a chemical-precipitation reaction between cocaine and the precipitating reagent. The habit and the aggregation of the crystals formed could be used to distinguish cocaine from other drugs (6).  
5.2 This technique can be utilized on cocaine present in either the salt or free base form.  
5.3 This technique does not distinguish between the salt and free base forms.
SCOPE
1.1 This practice describes procedures applicable to the analysis of cocaine using multiple microcrystal tests (1-6).2  
1.2 These procedures are applicable to cocaine, which is present in solid form or an injectable liquid form. They are not typically applicable to the analysis of cocaine in biological samples.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 These procedures could generate observations indicating a positive test for cocaine or its enantiomers which could be incorporated into the analytical scheme as defined by the laboratory.  
1.5 This standard cannot replace knowledge, skills, or abilities acquired through appropriate education, training, and experience (see Practice E2326) and is to be used in conjunction with professional judgment by individuals with such discipline-specific knowledge, skills, and abilities.  
1.6 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.  
1.7 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.

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ASTM
ASTM E2125-19(Practice)
Standard Practice for Microcrystal Testing in Forensic Analysis for Phencyclidine and Its Analogues

SIGNIFICANCE AND USE
5.1 This technique involves a chemical-precipitation reaction between the phencyclidine or its analogues and the precipitating reagent. The habit and the aggregation of the crystals formed could be used to distinguish phencyclidine or its analogues from other drugs.  
5.2 This technique can be utilized on phencyclidine or its analogues present in either the salt or free base form.  
5.3 This technique does not distinguish between salt and free base forms.
SCOPE
1.1 This practice describes procedures applicable to the analysis of phencyclidine and its analogues using microcrystal tests (1-8).2  
1.2 These procedures are applicable to phencyclidine and its analogues which are present in solid form or in a liquid form. They are not typically applicable to the analysis of phencyclidine and its analogues in biological samples.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 These procedures could generate observations indicating a positive test for phencyclidine and its analogues which could be incorporated into the analytical scheme as defined by the laboratory.  
1.5 This standard cannot replace knowledge, skills, or abilities acquired through appropriate education, training, and experience (see Practice E2326) and is to be used in conjunction with sound professional judgment by individuals with such discipline-specific knowledge, skills, and abilities.  
1.6 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.  
1.7 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.

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