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ASTM E1532-00(2006)

(Practice)

Standard Practice for Detection of Mycoplasma Contamination of Cell Cultures by Use of Bisbenzamide DNA-Binding Fluorochrome (Withdrawn 2014)

Standard Practice for Detection of Mycoplasma Contamination of Cell Cultures by Use of Bisbenzamide DNA-Binding Fluorochrome (Withdrawn 2014)

SIGNIFICANCE AND USE
Mycoplasma hyorhinis, cultivar α strains (1)3 do not grow on any of the standard media used for mycoplasma cultivation. These strains, which are found as contaminants in cell cultures, are detected by indirect methods.
A specialized medium has been described but it is not yet in wide use (2).
This practice should be used in conjunction with Practice E 1531.
All cell cultures to be examined for mycoplasma should undergo a minimum of two passages in antibiototic-free tissue culture medium before testing.
SCOPE
1.1 This practice covers the use of cell cultures and DNA-binding flurorochrome techniques to detect mycoplasma contamination of cell cultures.
1.2 This practice does not cover axenic cultivation or identification of mycoplasmas.
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.
WITHDRAWN RATIONALE
This practice covers the use of cell cultures and DNA-binding flurorochrome techniques to detect mycoplasma contamination of cell cultures.
Formerly under the jurisdiction of Committee E55 on Manufacture of Pharmaceutical Products, this practice was withdrawn in August 2014. This standard was withdrawn without replacement due to its limited use by the industry.

General Information

Status
Withdrawn
Publication Date
31-Oct-2006
Withdrawal Date
04-Aug-2014
ICS
07.100.10 - Medical microbiology
Technical Committee
E55 - Manufacture of Pharmaceutical and Biopharmaceutical Products
Drafting Committee
E55.04 - General Biopharmaceutical Standards
Current Stage
Ref Project

Relations

Replaces
ASTM E1532-00 - Standard Practice for Detection of Mycoplasma Contamination of Cell Cultures by Use of the Bisbenzamide DNA-Binding Fluorochrome
Effective Date
01-Nov-2006
Referred By
ASTM E2363-23 - Standard Terminology Relating to Manufacturing of Pharmaceutical and Biopharmaceutical Products in the Pharmaceutical and Biopharmaceutical Industry
Effective Date
01-Nov-2006

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ASTM E1532-00(2006) - Standard Practice for Detection of Mycoplasma Contamination of Cell Cultures by Use of Bisbenzamide DNA-Binding Fluorochrome (Withdrawn 2014)ASTM E1532-00(2006) - Standard Practice for Detection of Mycoplasma Contamination of Cell Cultures by Use of Bisbenzamide DNA-Binding Fluorochrome (Withdrawn 2014)
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ASTM E1532-00(2006) - Standard Practice for Detection of Mycoplasma Contamination of Cell Cultures by Use of Bisbenzamide DNA-Binding Fluorochrome (Withdrawn 2014)
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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: E1532 − 00(Reapproved 2006)
Standard Practice for
Detection of Mycoplasma Contamination of Cell Cultures by
Use of Bisbenzamide DNA-Binding Fluorochrome
This standard is issued under the fixed designation E1532; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope cultivation. These strains, which are found as contaminants in
cell cultures, are detected by indirect methods.
1.1 This practice covers the use of cell cultures and DNA-
binding flurorochrome techniques to detect mycoplasma con- 4.2 A specialized medium has been described but it is not
tamination of cell cultures.
yet in wide use (2).
1.2 This practice does not cover axenic cultivation or
4.3 This practice should be used in conjunction with Prac-
identification of mycoplasmas.
tice E1531.
1.3 This standard does not purport to address all of the
4.4 Allcellculturestobeexaminedformycoplasmashould
safety concerns, if any, associated with its use. It is the
undergo a minimum of two passages in antibiototic-free tissue
responsibility of the user of this standard to establish appro-
culture medium before testing.
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
5. Indicator Cell Cultures
5.1 BHK-21, 3T6, and Vero are the most widely used
2. Referenced Documents
indicator cell cultures. BHK 21 are maintained as monolayer
2.1 ASTM Standards:
cultures, which are trypsinized to prepare, cell suspensions as
E1531PracticeforDetectionofMycoplasmaContamination
needed (4-6).
of Cell Cultures by Growth on Agarose Medium
5.2 Fetal bovine is heat inactivated at 56°C for 30 minutes
before it is used in cell culture medium.
3. Terminology
5.3 Place previously sterilized 11 × 22-mm coverslips in a
3.1 Definitions:
10 × 35-mm plastic culture dishes.
3.1.1 axenic cultivation, n—cultivation free from other liv-
ing organisms.
5.4 Add 3.8 mL of cell suspension to each dish. The
3.1.2 direct mycoplasma detection, n—demonstration of suspension should be dilute enough so that the resulting
characteristic colonial growth on axenic agar medium. monolayer is subconfluent in 2 to 3 days. Growth medium is
replaced and the coverslip cultures are ready for use.
3.1.3 mycoplasma (Mollicute), n—smallest prokaryotes ca-
pable of self replication.
5.5 Inoculate 0.1 mL of sample into each culture dish.
5.6 For positive control, inoculate two dishes with M.
4. Significance and Use
hyorhinis, strain DBS 1050 (ATCC 29052).Additional control
4.1 Mycoplasma hyorhinis, cultivar α strains (1) do not
strains of M. orale or M. pirum are useful.
grow on any of the standard media used for mycoplasma
5.7 Two uninoculated dishes serve as negative controls.
6. Materials for Staining
This practice is under the jurisdiction of ASTM Committee E55 on Manufac-
ture of Pharmaceutical Products and is the direct responsibility of Subcommittee
6.1 Carnoy’s Fixative—Mix one part glacial acetic acid
E55.04 on General Biopharmaceutical Standards.
with three parts methanol. This fixative may be made in
Current edition approved Nov. 1, 2006. Published December 2006. Originally
approved in 1993. Last previous edition approved in 2000 as E1532–00. DOI: advance and stored at room temperature.
10.1520/E1532-00R06.
2 6.2 McIlvane’s Citrate-Phosphate Buffer, pH 5.5:
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
6.2.1 0.1 M Citric Acid Monohydrate (MW 210.14)—Add
Standards volume information, refer to the standard’s Document Summary page on
21 g to 1000 mL of deionized water.
the ASTM website.
6.2.2 0.2 M Dibasic Sodium Phosphate (MW 141.96)—Add
Theboldfacenumbersinparenthesesrefertothelistofreferencesattheendof
this standard. 34.08 g to 1200 mL of deionized water.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E1532 − 00 (2006)
6.2.3 For working solution, combine 572 mL of 0.2 M 7.7 Wash with distilled water, then air dry.
dibasic sodium phosphate with 450 mL of 0.1 M citric acid.
7.8 Mount preparations by placing each coverslip (cell side
6.2.4 Store buffer at 2 to 8°C.
up) onto a drop of mountan
...

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SCOPE
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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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5.4 Detecting microbial contamination levels that exceed predetermined upper control limits indicates the need for an addition of an antimicrobial agent or other corrective maintenance action. By accurately determining this in a shorter time period than is possible than by culture methods, treatment with antimicrobial agents may circumvent more serious problems than if the treatment were postponed until culture results were available. If the antimicrobial treatment program relied on an inaccurate non-culture test, then unnecessary loss of product and problems associated with inappropriate selection or improper dosing with antimicrobial agents would exist.  
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SCOPE
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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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