Calibration and Operating Procedure for pH Meter

• Objective:To lay down procedure for Calibration and Operation of pH Meter.

• Scope:This standard operating procedure is applicable for formulation plant of Pharmaceutical company name with location.

Make: Mettler Toledo.

• Responsibility
  • Trained worker / Operator shall be responsible for performing the calibration and operation of the equipment as per this SOP.
  • Production Supervisor / Officer shall be responsible for implementation of this SOP.
  • Head-Production / designee shall be responsible for compliance of this SOP.
• Abbreviations and Definitions

pH –   – log [H⁺]

MTC –  Manual Temperature Compensation

ATC –  Automatic Compensation

HDPE – High Density Poly Ethylene

SOP –  Standard Operating Procedure

mv – milivolt

QA – Quality Assurance

• Procedure
  • Calibration Procedure:
    • Take 20 ml Hamilton buffer solution from buffer bottle in its measuring cup by pressing the bottle.
    • Use this solution within one week. calibrate the pH meter weekly.
    • 1^st-Point Calibration for pH “7.00”
      • Remove the cover from tip of the electrode.
      • wash electrode with purified water and dry with tissue paper
      • Set the temp. at 25ºC by pressing temp key and Up/ Down scroll key.
      • For Auto Mode, place the electrode in a calibration buffer of pH 7.00 and press ‘Cal’
      • End point reaches automatically. It shall display pH at particular temperature.
      • For manual Mode press A.
      • Meter shall display value of calibrated pH and freeze the buffer value.
      • To return to Sample measurement press Read A key.
    • 2^nd – Point Calibration for pH “4.01”:
      • After 1^st point calibration, wash electrode with purified water and dry with tissue paper.
      • Place the electrode in solution of pH 4.01 buffer and press ‘Cal’
      • pH meter shall display reading automatically when endpoint reaches and calibrated, for manual mode press Read A key.
      • pH meter shall display pH value on the screen and value shall be freezed.
      • To return in measurement by pressing Read A key.
    • 3^rd – Point Calibration for pH “9.21”
      • Perform the steps as in 1^st and 2^nd end point calibration.
    • Frequency of Calibration:
      • Calibrate the pH meter weekly.
      • Record all the observation in pH calibration record (Annexure-1).
      • After calibrations affix ‘calibrated’ tag on the equipment.
    • Operating Procedure:
      • Temperature Setting:
        • Press Temperature key to set the Temperature in manual mode and its value can be increase or decrease by using UP/DOWN scroll key.
        • By press READ A key for confirming the setting?
        • By pressing and holding pH/ mv key printer signal shall be display in screen and print shall be obtained.
      • Place the electrode in the sample and press ‘ReadA’ key for the measurement.
      • Display shows the actual pH of the sample.
      • Wait till the sensor output valve has been stabilized, the display freezes automatically and ‘A’ appears on the screen.
      • By pressing and holding the ‘read A’ key, auto and manual end point mode can be interchanged.
      • To measure mv press pH/mv key, during the pH measurement.
    • Forms and Records
      • pH METER CALIBRATION RECORD – Annexure-I
    • Distributions
      • Master Copy – Documentation Cell (QA)
      • Controlled Copies – Production and Quality Assurance

• History

Date	Revision Number	Reason for revision
–	00	New SOP

Annexure-I

                                       pH METER CALIBRATION RECORD

Equipment ID No.:

Date and Time	Temperature	1st Point Calibration	2nd Point Calibration	3rd Point Calibration	Calibration	Done By	Checked By	Due Date
		Buffer Solution ±0.01 Observed Value	Buffer Solution ±0.01 Observed Value	Buffer Solution ±0.02 Observed Value	OK / Not Ok

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