Saturday, 22 December 2018

What are the test parameters in the nitrogen gas validation?


Test parameters during validation and its frequency are given below:

a) Test for oil mists - Every 6 months once

 b) Test for moisture content - Every 6 months once

c) Particulate count (Non-viable) - Every 6 months once

d) Sterility test (Aseptic area locations) - Every 6 months once

e) Bioburden test (Controlled area locations) - Every 6 months once

The purity of nitrogen gas (Based on manufacturer COA)

 * Perform the nitrogen gas sampling & testing for three consecutive days.

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