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Union of India - Section

Section 115 in The Drugs and Cosmetics Rules, 1945

115. 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.