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Formerly under the jurisdiction of Committee E55 on Manufacture of Pharmaceutical Products, this practice was withdrawn in August 2014. This standard was withdrawn without replacement due to its limited use by the industry.

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.

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.