Sanitization of Purified Water Generation and Distribution System

• Objective:To lay down a procedure for Sanitization of Purified Water Generation and Distribution system.
• Scope:This Standard Operating Procedure is applicable to the formulation plant of pharmaceutical Company.
• Responsibility
  • The Concerned Technician shall follow the Sanitization Procedure as per this SOP.
  • The Officer/Executive-Engineering shall be responsible for implementation of the procedure as per this SOP.
• Accountability: Head-Engineering and QA shall accountable for the compliance of the procedure as per this SOP.
• Abbreviations and Definitions:
• RO:  Reverse Osmosis
• MCB: Miniature Circuit Board
• MCF: Micron Cartridge Filter
• EDI :Electro De-Ionization
• MMI: Man Machine Interface
• EHE: Electric Heater
• NMT: Not More Than

• Procedure:
• Sanitization of Purified Water Generation System
• RO membranes are sanitized by using RO permeate which filtered through MCF . The water in tank  is heated by means of electrical heater which is installed inside the tank.
• Sanitization procedure is as follows:

• Make sure that the main supply of 240 Volts to panel is coming properly and turn “ON” all MCB switches.
• For RO-1 sanitization open pump suction valve and Discharge valve and all other valves are closed.
• For RO-2 sanitization open pump suction valve  and discharge valve.
• For EDI sanitization open the pump suction valve and discharge valve.
• Start the pump and circulate warm water (NMT 45°C) with a maximum pump discharge of 2.5 kg/cm².
• Start the heater EHE. Set temperature as 85°C and temperature rises at NMT 4°C per minute.
• Continue the circulation till the temperature reaches up to maximum 85°C.
• When temperature reaches 80°C switch “OFF” the heater EHE. Don’t stop circulation.
• Maintain temperature for 60-90 minutes.
• After completion of sanitization allow system to cool to 45°C or below.
• Flush the system with water of maximum feed pressure of 2.5 kg/cm².
• Frequency: minimum twice a month.
• Monitor and Record all the observations in log sheet (Annexure1).

• Sanitization Procedure For Distribution System
  • Switch “ON” the main power supply to the panel by means of starter switch at side of control panel.
  • Turn “ON” the MCB inside the control panel for powering the PLC and MMI.
  • Press the ‘ENTER’ button on the MMI to start the system.
  • Make sure the utilities (i.e. compressed air and steam) are available to the system at required pressure and temperature respectively.
  • Make sure all the pump suction and discharge valves are kept open.
  • Make sure the MCB for the pumps are turned “ON” inside the control panel.
  • Put the system in ‘AUTO’ mode with the help of selector switch (AUTO /OFF/ MANUAL) on the panel door.
  • Drain the water in  storage tank T-2101 till the water level reaches for sanitization by opening the drain valve or feed the water to reach water level if the water level is low.
  • Press the SET button on the main screen to go to SET parameters for sanitization of distribution system.
  • Enter the time for sanitization say 60 mins.
  • Enter the temperature for sanitization as 85°C at which the system is to be sanitized and the Hysterisis value for the temperature set point as 4^°C
  • To put the system in sanitization mode turn “ON” the sanitization selector switch.
  • Ensure that all the drain / sampling valves are in closed condition.
  • The tank steam inlet valve  will open and close depending on the temperature of the water for a pre settable time. As soon as the temperature of water in return line reaches above the specified value then actuated valve turns OFF.
  • During sanitization, all the valves and pumps will be operational with the help of Selector switches and push buttons on the main door.
  • After completion of sanitization cycle, turn “OFF” the sanitization selector switch.
  • Empty the Distribution system by opening the drain valves. Also open up all the sampling valves while draining off the system.
  • Let the tank be as it is for atmospheric cooling for 15-20 mins.
  • Fill in fresh water in the tank and recalculate for 30 mins.
  • Again drain the whole system and fill fresh UF water.
  • The distribution system is now ready for operation.
• Forms and Records
  • Record of Sanitization of Purified Water System- Annexure-I
• Distribution
  • Master Copy : Documentation Cell (QA)
  • Controlled Copies : Engineering, Production, Quality Assurance, Warehouse,Quality Control, Administration and House Keeping
• History

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