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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