Detection of Brucella contamination.

9 C.F.R. § 113.32
in effectEffective: 2024-07-01
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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.

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