Operating Procedure for Purified Water Generation System

  • Scope:This Standard Operating Procedure is applicable to the formulation plant of Pharmaceutical Company(Make-Neela Metal ,Capacity -2.5m3/hr) .
  • Objective:To lay down an Operating Procedure for Purified Water Generation System.
  • Volts: Voltage
  • Amps : Amperes
  • PH : Proportionate Hydrogen
  • Kg/cm2 :Kilogram per Centimeter Square
  • m3/hr :Meter Cube per Hour
  • µS/Cm: Micro Siemens per Centimeter
  • UF: Ultra Filtrations
  • EDI :Electro Deionization
  • MCF: Micron Cartridge Filter
  • NMT: Not More Than
  • NLT: Not Less Than
  • HPP: High Pressure Pump
  • RO: Reverse Osmosis
  • Abbreviations and Definitions:
  • Accountability:Head-Engineering and QA shall be accountable for the compliance of the procedure as per this SOP.
  • Responsibility
    • The Concerned Technician shall follow the Operating Procedure as per this SOP.
    • The Officer/Executive-Engineering shall be responsible for implementation of the procedure as per this SOP.
  • Procedure
    • Switch “ON” the main switch of RO- panel.
    • Open the soft water supply pump suction valve and discharge valve
    • Start the soft water pump.
    • Start the dosing of anti-scalent and PH- correction.
    • Check the free chlorine and pH on ORP meter and PH check point.
    • Remove the air from MCF through vent valve.
    • Start the HPP and flush the RO-1 membranes for 5 to 10 minutes.
    • Adjust Valve to desired pressure and flow.
    • Membrane inlet water pressure – NMT 6.8 kg/ cm2.
    • Permeate water flow -NLT 3.66 m3/hr.
    • Reject water pressure between 4 to 5 Kg/cm2.
    • Reject water recirculation -NLT 2.5 m3/ hr.
    • Start the HPP  and flush the RO -2  for 5 to 10 minutes.
    • Adjust the V to design pressure and flow. (RO-]2)
    • Membrane inlet water pressure between 6 to 7 kg / cm2
    • Permeate water flow – NLT 3 m3 / hr.
    • Reject water pressure between 3 to 4 kg / cm2.
    • Reject water recirculation flow 1.5 to 2 m3/ hr.
    • Start EDI feed pumps.
    • When water comes out from EDI start the rectifier..
    • Ensure the valve  is completely open.
    • EDI inlet water pressure – NMT 3.0 Kg/cm2.
    • Permeate water flow – 2.6 m3/ hr.
    • Start the rectifier and adjust the current (6Amps-10Amps) and voltage (200Volts-300Volts) for required quality of water.
    • Adjust the Valve for the desired water flow from UF.
    • Permeate water flow – 2.5 m3/ hr.
    • Reject water pressure between 0.2 to 0.4 Kg / cm2.
    • Record all the observation of Purified Water System in the Log Sheet. As per Operation.
    • Parameter Conductivity should be less than 60 µS /Cm for RO-1, less than 40 µS /Cm for RO-2 and less than 1.3 µS /Cm for after EDI and UF outlet.
  • Forms and Annexure
  • Logbook of Purified Water System : Annexure-I
  • Distribution:
  • Master Copy: Documentation Cell
  • Controlled Copies: Engineering, Production, Quality Assurance,Warehouse, Quality Control, Administration and House Keeping
  • History:                        
Date Revision Number
Reason for Revision
00 New SOP

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About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 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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