Operating procedure for milli Q water system

• OBJECTIVE
• To lay down the procedure for Operation of Milli Q water system, Make Millipore.
• SCOPE
•  This SOP shall provide the Operating procedure of Milli – Q water system of quality control department.
• RESPONSIBILITY
•  Officer/ Executive – Quality Control
• ACCOUNTABILITY
• Head QC/QA

• PROCEDURE
• OPERATION OF ELIX –10

• Switch on Elix – 10 power supply button provided backside of the instrument.
• Indicator green light glows and LCD Screen displays

ELIX 10

SR.NO-

• Above information shall be displayed for few seconds and system goes in stand by mode.
• System starts performing flushing and returns to normal stand by mode.
• Press and hold for about 5 seconds operate / stand by button to switch in to operation mode.
• In operation mode system collects water from source and starts purification.
• The LCD screen while operation mode shows

PRES :            XXX       %TANK

RO Feed:        XXX        µ S

• Note:  Do not operate the system with pressure less than 2.0 kg/cm² (system starts alarm – red light blinks and LCD shows LOW PRES) , if required switch on the power of primary cartridge filter pump for required pressure.
• Purified water generated from the ELIX –10 collected continuously in HDPE – 30 liters storage tank.
• System stops/ starts automatically when HDPE TANK is full/empty.
• Note:  Do not collect water from storage tank when ELIX –10 Screen shows less than 30  % tank full, allow the system to collect water minimum up to 60 % tank full condition.
• Whenever required, Collect the water from HDPE storage tank for the purpose of dissolution / disintegration testing and their bath filling purpose only.

• OPERATION OF GRADIENT A 10
• Switch on GRADIENT A 10 power supply button provided backside of the instrument.
• Indicator green light glows and LCD Screen displays

GRADIENT A 10                                  V 3.05

SR.NO°

for few seconds and starts in stand by mode.

• Press and hold for about 5 seconds OPERATE / STAND BY button to switch in to operation mode.
• Move the point of use trigger forward till the green bulb glowing starts to initiate the water purifying process.
• When the bulb is glowing GRADIENT A 10 LCD screen shows the quality of water in terms of conductivity in µS at @25°C and TOC level in ppb.
• Move the point of use trigger forward and collect the required quantity of water.
• Close the point of use trigger backward after collecting water.
• This water shall be used for all laboratory grade water (i.e. – for the purpose of HPLC analysis, column washing, glassware final rinsing, chemicals/ reagents preparation, final dilutions).
• NOTE:

1. Do not use the water if conductivity is more than 1.3 µ S and TOC level is more than 500 ppb.

2.  Do not collect water when HDPE TANK is ≤ 30 % full. Allow the system to collect water minimum up to 60 % of tank full condition.
3.  Replacing frequency of Cartridges of  ELIX –10 / GRADIENT A10 shall be half – yearly or if the system fails to produce the water of required quality ( conductivity – ≤ 1.3 µ S and TOC –  ≤ 500 ppb.
4. Note the reading of conductivity & TOC ,twice in a day, preferably startup & end of the shift .

• Forms and Records (Annexures)
• Not Applicable
• Distribution
• Master copy –  Quality Assurance
• Controlled copies- Quality Assurance, Production, Quality Control.engineering
• History
  

  Date	Revision Number	Reason for Revision
  –	00	New SOP

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