CALIBRATION OF AUTOTITRATOR AND ELECTRODES

• OBJECTIVE:

To lay down the procedure for Calibration of auto titrator and electrodes.

• SCOPE:

• This SOP is applicable to the procedure for Calibration of auto titrator and electrodes at {Company Name} {Location}.

• RESPONSIBILITY:
• Officer/Executive/Designee Quality Control – Shall be responsible for calibration of instrument as per SOP.
• Head/Designee Quality Control – Shall be responsible for ensuring compliance as per SOP.
• ACCOUNTABILITY:

QA Head shall be Accountable for implementation of SOP.

• PROCEDURE:
• Calibration of burette:
• Operate the instrument as per Sop, Rinse well the burette and fill the Burette with purified water.Take a clean, dry 10ml volumetric flask.
• Weigh the volumetric flask and note down the weight as W1.
• Set the dispense volume as 1 ml and dose the water into the Volumetric flask.
• Weigh the volumetric flask with water and note weight as W2.
• Repeat the above 3 steps for volumes 2,3,4,5,6,7,8,9,10 respectively.Mread = W2 – W1
• Vactual = Mread x Density
• Calculate the relative error using the formula
• Relative error = (Vactual –Vset) x 100/Vset
• Density calculation:
• Take a pycnometer and note down the empty weight (W1).
• Fill the pycnometer with water, close the stopper provided and wipe off the excess water.
• Now note down the weight of pycnometer with water at 25°C (W2).
• Weight per ml of water = (W2-W1)/Volume of Pycnometer.
• Enter the details of calibration in calibration record as per format-I.
• Acceptance criteria: the average of Relative error should not be more than ± 0.5%
• Auto titrator calibration:
• Select a standard titration (KHP versus NaOH) suggested by Metrohm.Prepare 0.1M NaOH solution and perform the standard titration for five times.
• Calculate the molarity of NaOH for five titrations.
• Calculate the RSD for molarity using the formula RSD = Standard Deviation % 100 Mean
• Acceptance criteria: RSD value should not be more than ± 0.5%.
• Enter the details in calibration record as per format-II.
• If the calibration is not within the specified limits repeat the calibration.
• Report the Results to the department head for appropriate action.

Click the link to download word file copy of this document:
https://pharmaguidehub.com/product/calibration-of-autotitrator-and-electrodes/

• REFERENCES:

Not Applicable

• ANNEXURES: 

         ENCLOSURES: SOP Training Record.

•  DISTRIBUTION:
• Controlled Copy No. 01  :          Head Quality Assurance
• Controlled Copy No. 02  :         Head Quality Control
• Master Copy                    :          Quality Assurance Department
• ABBREVIATIONS:

• REVISION HISTORY:             

CHANGE HISTORY LOG

Annexure-I
BURETTE CALIBRATION RECORD

Annexure-II
AUTO TITRATOR CALIBRATION RECORD

Annexure-III
ELECTRODE CALIBRATION RECORD-pH Electrode

Annexure-IV
ELECTRODE CALIBRATION RECORD-SOLVOTRODE

Annexure-V
ELECTRODE CALIBRATION RECORD-Combined Ag ring

Click the link to download word file copy of this document:
https://pharmaguidehub.com/product/calibration-of-autotitrator-and-electrodes/