Passivation of Purified Water and Water for Injection Storage and Distribution System

1.0. OBJECTIVE :

1.1 To lay down a procedure for Passivation of Purified Water and Water for Injection Storage and Distribution System .

2.0. SCOPE :

2.1 This procedure is applicable to Purified Water and Water for Injection Storage and Distribution System situated at pharma dekho

3.0. RESPONSIBILITY :

3.1 Operator Engineering Department shall be responsible for passivation of purified and WFI water storage and distribution loop and maintaining the passivation record.
3.2 Officer/Executive Engineering Department shall be responsible for to verify the proper passivation and to take corrective action if any operational deviation.

4.0. ACCOUNTABILITY :

4.1 Head Engineering Department shall be accountable for compliance of SOP.

5.0. PROCEDURE :

5.1. Ensure that the supply of all instruments and pumps in the loop are ‘Off’.
5.2. Drain out the Purified water / WFI from storage tank and distribution line by opening the drain valve.
5.3. Close the drain valves.
5.4. Remove all sensors from the distribution loop.
5.5. Plug all sensor-inserting points with Stainless Steel (SS) plugs.
5.6 Ensure the zero dead leg valves at the user points are closed.
5.7 Collect a quantity of Purified Water / WFI equal to the approx. 25% total storage capacity of tanks(1000 ltr
for purified water and 375 ltr for WFI).
5.8 Add calculated quantity of Concentrated Nitric Acid to prepare 1% solution in storage tanks (10 ltr
concentrated Nitric acid for purified water and 3.75 ltr concentrated Nitric acid for WFI).
5.9 Start continuous water circulating loop and allow Nitric Acid Solution to circulate through Heat Exchanger.
5.10 Set temperature of Heat Exchanger and time of circulation of Nitric Acid Solution in loop as per table given
below-

Sr. No.	Temperature of solution in loop (NLT)	Time period for circulation in loop
1	80 ºC	2.0 hours

5.11 Start the close loop supply pump by keeping the water system control panel on manual mode and turn the
pump ON / OFF knob to ‘On’ position.
5.12 Circulate the acid solution through the close loop as per mentioned in table.
5.13 After 2 hours, drain out the solution by opening the drain valve.
5.14 Close the drain valve and fill the storage tank with purified water / WFI respectively as mentioned at 5.7.
5.15 Again re-circulate the water for half an hour and drain out it.
5.16 Rinse the loop for 1 hour with purified water or till conductivity and pH parameters not achieved as per limits
specified.
5.17 During rinsing, take the water sample, check the conductivity and pH. If it is same as purified water
(conductivity1.25µs/cm and pH 5-7), stop the rinsing. Otherwise keep the system in continuous rinsing till get pH
and conductivity as specified.
5.18 After getting the specified quality of water, fill the tanks with purified water / WFI and refit all sensors in the
loop.
5.19 Switch ‘On’ all instruments and pumps in the loop and operate the Purified Water Storage and Distribution
System or WFI Storage and Distribution System as per SOP No.
5.20 Passivation of the Purified and WFI water loop shall be carried out once a year.

6.0. ABBREVIATION :