sop for Passivation of WFI Distribution Loop
To lay down a procedure for Passivation of WFI Distribution Loop.
This Standard Operating Procedure is applicable for Passivation of WFI Distribution Loop to be followed at formulation plants
3.1 Officer / Executive Engineering shall be responsible for the execution of this procedure.
3.2 Engineering Manager shall be responsible for the implementation of this SOP.
3.3 Head QA/designee shall be responsible for the compliance of this SOP.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
No : Number
NA : Not Applicable
QA : Quality assurance
Sr. No : Serial number
ER : Engineering
WFI : Water for Injection
5.1.1 Ensure that the supply of all instruments and pumps in the loop are ‘Off’.
5.1.2 Drain out the storage water and water distribution line by opening the drain valve.
5.1.3 Close the drain valves.
5.1.4 Remove all sensors from the distribution loop.
5.1.5 Plug all sensor-inserting points with Stainless Steel (SS) plugs.
5.1.6 Keep the zero dead leg valves at the user points are closed.
5.1.7 Prepare 500 liters of 1 % (percent) warm nitric acid solution in water distribution tank.
5.1.8 Start the close loop supply pump by keeping the water system control panel on manual mode.
5.1.9 Re-circulate the acid solution through the close loop for 2 hours.
5.1.10 After 2 hours, drain out the solution by opening the drain valve.
5.1.11 Close the drain valve and fill the storage tank with WFI water.
5.1.12 Again re-circulate the water for half an hour and drain out it.
5.1.13 Rinse the close loop for 1 hour with WFI water.
5.1.14 Take the water sample during rinsing, check the conductivity and pH. If it is same as purified water (conductivity-<1microsiemens/cm and pH 5-7), stop the rinsing. Otherwise keep the system in continuous rinsing till get pH and conductivity as specified.
5.1.15 After getting the specified quality of water, fill the tanks with WFI water and refit all sensors in the loop.
5.1.16 Switch ‘On’ the instruments.
5.1.17 Start the PLC (Programmable Logical Control) based water system and takes the loop in service.
5.1.18 Start the PLC (Programmable Logical Control) based water system and takes the loop in service.
5.1.19 Frequency of Passivation:
5.2.1 Passivation of the WFI water loop has to be carried out once a year.
6.0 Forms and Records
6.1 Passivation Record of WFI Water Loop. – Annexure-1
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Controlled copies – Engineering Department