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Formerly under the jurisdiction of Committee E55 on Manufacture of Pharmaceutical Products, this practice was withdrawn in August 2014. This standard was withdrawn without replacement due to its limited use by the industry.

This practice covers the procedures used for detection of mycoplasma contamination of cell cultures by growth on agarose medium. This practice does not cover identification of mycoplasma and indirect methods for detection of mycoplasma. This practice will not detect cultivar strains of Mycoplasma hyorhinis nor intended for use in detection of mycoplasma contamination in sera, culture media, vaccines, or other systems. The practice involves DM-1 solid medium preparation, quality control, and mycoplasma isolation.

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) of Mycoplasma hyorhinis.

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.