Amendment status not verified — confirm the current text below against the official source.
Application of tests for sterility.–The tests shall be applied− (a) to samples taken from each batch of the substance before the operation of filling and sealing the containers in which it is to be issued has commenced except preparations, which after being sealed in the containers are to be sterilized by heat, in a manner satisfactory to the Licensing Authority; and (b) to the contents of sample containers when ready for issue. 4 * * * * * 119.−(1) If at this examination no growth of micro-organisms is found in any tube, the sample may be treated as having passed the test. (2) If at the examination a growth of micro-organisms is visible, further samples may be taken and the tests may be repeated on the further samples taken; but no container the contents of which form part of the batch shall be issued until such further samples have passed the test. The process of taking samples from the batch for a test may be repeated twice: Provided that if the same organism is visible in more than one test the batch shall be treated as not sterile and the material contained in the batch shall not be issued or used as part of a further batch unless and until it has been re-sterilized and has passed the tests. 120.−Notwithstanding anything contained in the last preceding rule, in any case where— (a) a substance is required in an emergency by a registered medical practitioner, but the licensee has no filled containers in stock; or ___________________________________________________________________________________