Passivation and Cleaning Procedure Purified Water Distribution Loop

October 24, 2016January 16, 2024 Pharmaceutical Guidanace

Objective : To ensure that the Purified Water Distribution System is Chemically cleaned.
Scope :Applicable for Passivation and Cleaning of Purified Water Distribution Loop
Procedure :
Fill the Purified Water Storage Tank till the Half Level.
Ensure Suction & Discharge valve of pump are open and all user points & sampling valves are closed.
Start the recirculation pump & circulate water for 25 – 30 min.
Then drain the water from the tank & piping via user points & sampling points.
Prepare Cleaning chemical by diluting Nitric acid (HNO3) of 2% concentration in Purified Water.
Start the recirculation pump and circulate the cleaning chemical for 45-60 min.
Then drain the cleaning chemical from the tank & piping via user points & sampling points.
Prepare Passivation chemical by diluting Sodium Hydroxide (NaOH) (of 100% purity) with water with 1% of concentration.
Start recirculation pump and circulate the Passivation chemical for not less than
1 hr.
Drain the Passivation chemical from equipments and recirculation loops via each user points.
Transfer fresh water to Purified Water Storage Tank.
Flush the equipment and recirculation loops with purified water till the pH is neutral (6 to 7) or to the in feed water quality.
Observation should be filled in Cleaning & Passivation Report Sheet.

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