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This practice covers the procedures used for detection of mycoplasma contamination by direct microbiological culture.
Formerly under the jurisdiction of Committee E55 on Manufacture of Pharmaceutical Products, this practice was withdrawn in August 2014. This standard was withdrawn without replacement due to its limited use by the industry.
1.1 This practice covers the procedures used for detection of mycoplasma contamination by direct microbiological culture.
1.2 This practice does not cover indirect methods for detection of mycoplasma such as DNA staining, biochemical detection, or genetic probes.
1.3 This practice does not cover methods for identification of mycoplasma organisms.
1.4 This practice will not detect cultivar strains
1.5 This practice is not intended for use in detection of mycoplasma contamination in sera, culture media, vaccines, or other systems.
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 (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
E1532 Practice for Detection of Mycoplasma Contamination of Cell Cultures by Use of Bisbenzamide DNA-Binding Fluorochrome