SOP ON OPERATION AND CALIBRATION OF pH METER (QC)

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SOP ON OPERATION AND CALIBRATION OF pH METER

 

  • OBJECTIVE: 
  • The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for Operation and Calibration of PH Meter. Make:……, Model: …….  ID No: ……
  • SCOPE:
  • This SOP is applicable to PH Meter in the Quality Control Department at Pharmaceutical manufacturing facility.

 

  • RESPONSIBILITY:

 

  • Analyst / Section Head or his designee shall be responsible for following the SOP.
  • The Analyst is responsible to perform the test and maintaining the recording data.
  • The Head of the Quality Control Department or his designee shall be responsible for the implementation of the SOP.

 

  • PROCEDURE:
  • The procedure should be taken from the User Manual.

 

  • PRELIMINARY CHECK:
  • Check that the instrument is clean and free from dust, if not; clean with a soft cloth duster.
  • Always preserve the electrode in pH 4.0 Buffer. Do not leave it the electrode in purified water. (Make: ….) (OR as per the storage condition is given in the manual of the electrode)

 

  • Precautions:

  • The procedure should be taken from the User Manual.
  • Ensure that the instrument is cleaned before use. If not, clean it. Clean the instrument after use.
  • Check that the instrument is connected to the main power supply.
  • Do not expose the instrument to any type of magnetic field.
  • Do not unplug the power when the instrument is on. First, switch off the instrument before unplugging.
  • Check the instrument is kept on the vibration-free table/platform.

 

  • Basic operation:
  • Connect the pH meter to the main power supply and switch ON the instrument.
  • Check the LCD Display status after power on- main screen.
  • Press the RESET key and check the system resets and initializes.
  • Press active keys on the front panel & check for the buzzer beeps.
  • The instrument is now ready for use.
  • Set up the electrode stand & fit the pH electrode into it.

 

  • CALIBRATION:
  • Calibration should be as per given in Reference document or user manual.

 

  • Frequency:  Daily

 

  • pH Measurements

  • Operate the instrument as per the procedure mentioned above.
  • Rinse the electrode with distilled water and dip it in the Sample and Note the reading.
  • Cleaning Procedure:
  • Daily clean the instrument with a dry lint-free cloth or using tissue paper.
  • Always rinse the electrode before and after use.
  • Soak the tip of the electrode in 0.1 M Hydrochloric acid for one hour then rinse the electrode.
  • If any error observes in operation/calibration, inform to Section head or authorized Designee for necessary action.
  • Instrument Maintenance:
  • Regular maintenance schedule and proper storage of Ph electrode will minimize performances and help to extend the life of the electrode.
  • Inspect electrode for scratches, cracks salt crystals built up on membrane/liquid junction deposits.
  • Use a dedicated electrode storage solution (Buffer 4.01) to keep the electrode in proper working order.
  • Constant use of this solution will keep the electrode ready to use and provide a fast stable response.

 

  • Acceptance Criteria:
  • The pH value should be ± 0.05 of the specific value for the standard buffer solutions.
  • Slope %: 90 % to 105 %.

 

  • TRAINING: As per Training SOP

 

  • DISTRIBUTION: As Per Requirement.

 

  • ANNEXURE:
  • Annexure – I: Calibration test data sheet
  • Annexure – II: Instrument Usage Log Book

 

  • REFERENCES:
  • Instrument- User Manual

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