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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.

• • • Make: Millipore

• • • 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