SOPs

Procedure for Operation & Calibration of  pH Meter

STANDARD OPERATING PROCEDURE
Title:Procedure for Operation & Calibration of  pH Meter

 

  •    OBJECTIVE
    • This SOP describes the procedure for operation and calibration of pH Meter.
  • SCOPE
    • This procedure is applicable for operation and calibration of pH Meter in Quality Control Department.
  • RESPONSIBILITY
    • Officer / Executive-QC – responsible for Implementation of SOP.
  • ACCOUNTABILITY
    • Manager Quality Control
  • PROCEDURE
  • Operation
    • Before operating the instrument, clean the instrument properly.
    • Place the instrument on clean and flat surface near a power point.
    • Connect the unit to 230 V mains power supply.
    • Switch on the mains.
    • Press the ON/OFF key, pH meter automatically starts in last mode of operation.
    • Rinse the electrode with purified water & wipe the electrode.
    • Dip electrode in sample & show the pH.
    • After completion of pH clean the instrument.
    • Record the activity of instrument in log book of pH meter.
  • Calibration
    • PH meter calibrated daily with pH 4.0 and 7.00 buffer solutions.
  • Preparation of Buffer Solutions
    • Collect the tablets and follow the instruction as per manufacturer in this bottle for buffer solution pH 4.0 and 1.0.
    • Prepare the buffer solution after every 07 days. If there is any change in physically appearance, make the fresh buffer solution.
  • General Instructions
    • Check the validity of the buffer solutions before use.
    • After calibration do not switch off the pH meter. If done so, again calibrate the pH meter before use.
    • To remove excessive water from the electrode gently touches it over with a small piece of tissue paper. Never rub the electrode with tissue paper.
    • If pH meter is not in use for more than 48 hours, then immerse the electrode in saturated Potassium Chloride solution for one hour before use.
  • Calibration Procedure
    • Press the ON/OFF key, pH meter automatically starts in mode of operation.
    • Rinse the electrode with purified water and wipe the electrode.
    • Transfer approx. 50ml each buffer solution from stock buffer solution in 100 ml capacity dry beaker.
    • It will show “MEAS” on the top of display screen.
    • Press once again on/off button, it will show “CAL”. Wash the electrode & Dip in the buffer solution pH: 7.0 and wait till the upper value get stabilize and show ready mode.
    • Press enter. It will calibrate the value.
    • Take out and wash the electrode. Put it in buffer solution pH: 4.0 and wait till the upper value get stabilize and show ready mode.
    • Take out and wash the electrode.
    • Electrode should be always dipped in saturated KCL.
    • Fill the Calibration status label Format and affix it on the instrument.
    • Report any discrepancy observed during calibration of instrument to Quality Control In-Charge or his designee for corrective and preventive action.
    • Calibration should be required after maintenance.
  • Precaution and Cleaning:
    • Wash the electrode and reference junction in purified water.
    • Do not leave the electrode dry; keep the electrode in saturated KCl.
    • Do not wipe the glass electrode bulb with any coarse material. Use only tissue paper.
    • Dissolve the salts deposits by immersing the in a container filled with some tap water for ten to fifteen minutes. Then thoroughly rinse with purified water.
  •     ABBREVIATION

     SOP      –  Standard operating procedure

     QC       –  Quality Control

  •   FORMAT

NIL

  •    DISTRIBUTION LIST
Sr. No.Copy No.Department
Quality Assurance
Quality Control

 

ABHA

Abha is the Author  of pharmaceutical guidance, she is a pharmaceutical professional having more than 22 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd. During his experience, she faces many regulatorily audits 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. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube