§ 113.32 - Detection of Brucella contamination.

§ 113.32 Detection of Brucella contamination.

The test for detection of Brucella contamination provided in this section shall be conducted when such a test is prescribed in an applicable Standard Requirement or in a filed Outline of Production for the product.

(a) One ml of the minced tissue used as the source of cells or 1 ml of the extract of the tissue prior to the addition of antibiotics, diluent and stabilizer, shall be inoculated onto each of three tryptose agar plates and incubated in a 10 percent CO₂ atmosphere at a temperature of 35-37 °C for at least 7 days.

(b) If colonies are identified as Brucella, the biological product is unsatisfactory.

(c) If colonies suspicious of Brucella are observed but cannot be identified as a Brucella species, either

(1) The biological product shall be regarded as unsatisfactory and destroyed; or

(2) Further subculture or other procedures shall be carried out until a positive identification can be made.

[38 FR 29888, Oct. 30, 1973]