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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
Date Revision Number
Reason for Revision
00 New SOP



About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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