Paragraph 10

If at the examination at the end of the incubation period referred to in the preceding paragraph no growth of micro-organisms is found in the media to which the sample has been applied, the medicinal product shall be regarded as having satisfied the test.

If at any examination a growth of micro-organisms is found in the media to which the sample has been applied, a further sample may be taken from the batch and tested in accordance with the foregoing provisions of this Part of this Schedule.

If on examination during or after the incubation of the further sample no growth of micro-organisms is found, the medicinal product shall be regarded as having satisfied the test, but if growth of the same organism is found as was found in the first sample tested, the medicinal product shall be regarded as having failed to satisfy the test.

If on any examination of the further sample a micro-organism is found, but the same micro-organism as was found in the sample first tested is not found, a third sample may be taken from the batch and tested in accordance with the foregoing provisions of this Part of this Schedule.

If on any examination during or after the incubation of the third sample no micro-organism is found the medicinal product shall be regarded as having satisfied the test, but if any micro-organism is found the medicinal product shall be regarded as having failed to satisfy the test.

If the nature of the sample or any other factor makes the result of the test uncertain, then subculture shall be carried out and the subcultures shall be incubated and examined in accordance with the provisions of paragraph 9 above and the provisions of this paragraph.