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.
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.
If colonies are identified as Brucella, the biological product is unsatisfactory.
If colonies suspicious of Brucella are observed but cannot be identified as a Brucella species, either
The biological product shall be regarded as unsatisfactory and destroyed; or
Further subculture or other procedures shall be carried out until a positive identification can be made.
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