Operation and Maintenance of Milli Q Water System

Standard Operating Procedure (SOP) for Milli Q Water purification system for its operation, and general maintenance procedure.

SOP for Milli Q Water System

1.0   PURPOSE:

    • The purpose of this Standard Operating Procedure (SOP) is to describe the operation and maintenance procedure of the Milli Q Water System.

2.0   SCOPE – SOP for Milli Q Water System:

    • This SOP is applicable to the following Milli Q Water system at the Quality control department at the pharmaceutical drug manufacturing plant.
      • Model: Elix 10 / Academic

3.0   REFERENCES – SOP for Milli Q Water System:

    • Instruction Manual of the instrument

4.0   RESPONSIBILITY:

    • QC-Officer shall be responsible for :
    • To operate the Milli Q water system instrument as per the SOP.
    • Quality Control Head or Designee shall be responsible for :
    • To provide training to all concerned persons before the implementation of the SOP.
    • Quality Assurance shall be responsible for:
    • To ensure the implementation of the system as per SOP
    • Quality Head and Plant Head shall be responsible for:
    • To review and approve the SOP.

5.0   ABBREVIATIONS USED – SOP FOR MILLI Q WATER SYSTEM:

    • LED: Light-emitting display
    • NA: Not Applicable
    • QA: Quality Assurance
    • QC: Quality Control
    • SOP: Standard Operating Procedure

 6.0   PROCEDURE FOR HANDLING OF MILLI Q WATER SYSTEM:

    • Open the Feed water-isolating valve.
    • Switch “ON” the power to the system by moving the switch to position “I” located at the rear of the system.
    • The system displays the version and serial number for 10 seconds.
    • Then it will show the display of operating mode.
    • Press “OPERATE/STANDBY” for 2 seconds, the system goes to PREOPERATIVE mode.
    • Now the system is ready for use.
    • Moving the point of use, the trigger forward will initiate and start to dispense water.
    • The system will dispense water from the point of use of the gun.
    • When the dispensing is over move the trigger back to the vertical position to go to PREOPERATIVE mode.
    • When the point of use trigger is brought slightly forward, the Milli Q system goes into a RECIRCULATION mode.
    • The green LED will flash when the water quality is not optimal.
    • Once the green LED is lit steadily, the trigger can be brought forward to dispense water from the point of use of the gun.
    • If the resistivity is below the setpoint, the green LED will blink continuously.
    • Alarm System 

    • During the process, if the ALARM light is lit and display shows the following message “LOW PRESSURE” then restart the system as follows.
      • Press 2 seconds on OPERATE/STANDBY. Repeat this action if the unit goes back into the “LOW PRESSURE” mode.
    • If the message continuously persists contact Engineer for Technical service.
      • In PREOPERATIVE mode, press MEASURE to display temperature.
    • The CLEANING function is used for cleaning and sanitizing the ultrafiltration module.
    • To program a dispensing time period, in PRE OPERATE mode, press MENU for at least 2 seconds.
    • Select or change the volume of water you want to dispense from the Milli Q water system by pressing the MEASURE or CLEANING keypad under the PRESET VOLUME.
    • Press the OPERATE/STANDBY button to validate your volume selection.
    • Press the dispenser trigger forward and allow the water to dispense.
    • After dispensing the LCD will prompt you to ‘CLOSE THE VALVE’.
    • Bring the Dispenser trigger to the upright position.
    • To display the age of the purification cartridge, in PREOPERATIVE mode press MENU for at least 2 seconds. Press MENU twice, the age of the cartridge is shown.
    • Press MENU for at least 2 seconds, display returns back to initial operating mode.
    • Language Selection:

    • To choose display language, in PRE OPERATE mode press MENU for 2 seconds.
    • Now Press MENU four times.
    • Press the arrow keys to change between different languages.
    • Press MENU again to return to PREOPERATIVE mode.
    • This is a default setting for the English language.
    • To choose the unit of measurement for conductivity, in PRE OPERATE mode press MENU for 2 seconds.
    • Press MENU four times.
    • Press on OPERATE/STANDBY.
    • The arrow keys allow the choice of MWcm or m Siemens/cm as units.
    • Press MENU again for 2 seconds to return to the initial operating mode.
    • This is a default setting for MW
    • To choose the measurement unit for Pressure, press MENU for 2 seconds.
    • Press the MENU button the second time.
    • Press twice on OPERATE/STANDBY button.
    • One press on the MEASURE or CLEANING button allows the choice of the display unit.
    • Press 2 seconds on the MENU to validate units and to return to start.
    • The bar is programmed as a default position.

7.0   Routine Maintenance:

    • Replacing the QUANTUM Ultra-pure cartridge
    • Sanitization of the Ultrafiltration module
    • Replacing the Q-Gard Purification Pack
    • Replacing the MILLIPAK 40.
    • Cleaning the screen filter in the feedwater line.

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Related:

  1. SOP for pH meter
  2. SOP for Conductivity Meter

pharmabeginers

Janki Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an ultimate pharmaceutical blogging platform. Email: [email protected]il.com

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