This practice covers the procedures used for detection of mycoplasma contamination in serum 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Formerly under the jurisdiction of Committee E55 on Manufacture of Pharmaceutical Products, this practice was withdrawn in August 2014. This standard was withdrawn without replacement due to its limited use by the industry.

Mycoplasmas of bovine origin are prevalent contaminants of cell cultures. Contamination can be detected by the large volume method.^{3 ,4}

Heat inactivated serum need not be tested for mycoplasmas. Heating serum to 56°C for 30 min will kill mycoplasmas.

Mycoplasmas may be present in any particular lot of serum but may not be detected because of inadequate sample size; thus, negative test results do not provide absolute assurance that the test serum is free of mycoplasmas.

1.1 This practice covers the procedures used for detection of mycoplasma contamination in serum by direct microbiological culture.

1.2 This practice does not cover procedures used for detection of mycoplasma in cell cultures.

1.3 This practice does not cover indirect methods for detection of mycoplasma contamination.

1.4 This practice does not cover methods for identification of mycoplasma cultures.

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.