Passivation of Purified Water System/ WFI System in Pharmaceuticals

Purified water system and WFI system in pharmaceuticals are needed passivation from time to time. Following is the procedure or the same.
1. Take the required qty. of Nitric Acid (AR grade / commercial grade) after released by QC.
2. In case of commercial grade calculate the required qty. of Nitric Acid as per 10% AR grade with the help of QC (Attach COA of Nitric Acid).
3. Prepare the 10% V/V Nitric Acid solution with water kept in a tank and allow to recirculate the same to the required pipeline for 24 Hrs.
4. After successful recirculation of above solution drain it completely.

5. Again fill the tank with fresh water and recirculate it for at least 60 minutes, take a sample of fresh water to be filled and after recirculation for analysis of pH then drain.
6. Again fill the tank with fresh water completely and recirculate it for at least 60 minutes and then take samples from the predefined sampling points for the analysis of pH and drain it.
7. Repeat the same procedure until the pH value of feed water and sampled water after recirculation will be same. The limit of pH for recirculated water = + 1% of feed water. 

Related: RO System for Water Purification

Quantity required as per 10 % AR grade Nitric Acid :

                                                                                  100

Required commercial grade HNO₃ (%)   =      --------------------- x 10

                                                                            Assay of HNO₃

           

Total required HNO₃ (V/V) = Total Volume of water (Ltr.) x Required HNO₃ (%)

Also see: Use for UV Lamp for Purified Water System Disinfection

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