What are the test parameters in the nitrogen gas validation? : Pharmaceutical Guidelines

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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