Sanitization of WFI storage and Distribution
This Document describes (Standard Operating procedure) SOP for Sanitization of WFI storage and Distribution system.
SOP for Sanitization of WFI storage and Distribution system
I. Purpose & Scope:
- The Purpose of this SOP is to lay down the procedure for Sanitization of WFI storage and Distribution system
- This procedure is applicable to all Engineering Department for Sanitization of WFI storage and Distribution system
II. Responsibilities:
• All Engineering personnel’s shall be responsible to follow and implement this SOP.
III . Introduction and Procedural Part :
Procedure:
Auto Mode:
- Set the level in the WFI at medium level or below medium level. Switch on the normal- sanitization mode two switches on control panel to sanitization mode.
- The distribution pump should start.
- The actuated steam valve should open.
- After achieving temperature sanitization cycle must stop after 60 minutes giving an alarm on the screen.
- Sanitization cycle should stop by pressing STOP in sanitization mode screen.
Manual Mode:
- Switch on the control panel, operate the switch to manual position.
- Check and conform the sufficient water available in the tank (minimum 1/3 of capacity)
- Open the steam inlet valve of the jacket heat the water till the water temperature attains the 105°C.
- Open the Actuated Valve.
- Start the circulation pump and circulate the water through circulation loop.
- Check the circulation pump water attains the temperature of 95°C in the return line by RTD sensor.
- Start count the time of sanitization of tank and loop system. Maximum 4.0 hrs.
- After compilation of circulation of hot water, drain the water of the system and tank.
- Collect the fresh water.
- All data shall be monitored & logged in Sanitization of WFI Storage & Distribution System Log.
Frequency:
15 Days / as and when required.
ANNEXURE –I
Sanitization of WFI storage and Distribution system log
Area: Frequency: 15 Days / As and When Required
| Date | Pure Steam Inlet valve open time | Jacket Steam Pressure (NMT 0.5 psi) | Jacket Steam Temp. (NLT 140°C) | Crack Open
of Sampling valve status |
Temp. attains (105°C at Supply loop) | Temp. attains (95°C at Return loop) | Sanitization Mode
(60 Mins.) |
Done By (Sign.) | Remarks | |
| Sanitization Hold start time | Sanitization Hold Stop Time | |||||||||
Reviewed By : ________________ Verified By: _______________________
Dept. Head QA
