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Manufacturing Unit

Manufacturing Unit


Water for injection collection into mixing tank
a) Temperature of water for injection in mixing tank: 80 C.
b) Entry point analysis results : Draw the WFI sample and test for the following parameters – ph, Oxidizable matter, and BET and Bio byrden. Acceptance criteria: As per IP
c) WFI sample from mixing tank analysis results draw sample from the mixing tank and test for the followings parameters- Ph, oxidizable matter and bio burden Acceptance criteria: As per IP
d) Add and dissolve in to the above water for injection IP and mix by using stirrer.
e) Bulk solution stirred so as to form a homogenous solution.
f) Draw sample from mixing tank and test for following parameters– ph, bulk analysis and bio-burden.