SOP for Operation and Calibration of pH Meter in the Pharmaceutical Industry

 1. Purpose: 

 All complaints must be addressed by the established procedure for operating and calibrating the pH meter and conductivity meter.

 2. Scope: 

 This SOP  applies to the operation and calibration of the pH meter and the conductivity meter in (name and address of the company).

 3. Responsibilities: 

 Senior/Designated QC: Understand the procedure and apply it in practice. 

 QA Lead/Representative: Review the SOP and its implementation. 

 QA Manager/Representative: Approve SOP. 

 4. Material and  equipment:

 Operation and  calibration of pH  meter and  conductivity meter

 5. Procedure:


It is the measure of the acidic or basic solution. The pH meter and pH value are used for its measurement. The measurement is carried out on a scale from 0 to 14. The instrument is ergonomically designed and has intuitive functions. The keys are  grouped  according to the  function they perform.


 A solution can conduct electric current. Ions act as an electric current carrier through the solution (dissolved salts or acids). Ions become positively charged when they lose electrons, and ions become negatively charged when they gain electrons. Due to more particles in a  solution, electrons will rush. The answer becomes more conductive. A conductivity meter measures the total dissolved solids (TDS volume in the key).

 5.1  Precaution:

 5.1.1  Make sure the instrument is clean before use. 

 5.1.2 Do not expose the instrument to any magnetic field. 

 5.1.3  Make sure that the device stands on the table without vibration.

 5.1.4 the device should not be disconnected from the power supply when switched on. First, switch off the instrument before unplugging it.

 5.1.5 Soak the tip of the pH electrode in  0.1 M HCL for one hour, then rinse the electrode, and the conductivity electrode remains dry. 

 5.1.6  Make sure the instrument is clean before use. 

 5.2 Operation: 

 5.2.1  Turn on the main power supply. 

 5.2.2  Spectralab and Model pH  CON-1 are shown on the display.

 5.2.3 Press pH to calculate the pH value.

 5.2.4  The screen displays “Select User.”

 5.2.5 Enter the user by pressing the UP/DOWN  button.

 5.2.6 Press  Enter.

 5.2.7 Enter the password. 

 5.2.8  The same basis or operation can apply to conductivity and  TDS.

 5.2.9 Maintain usage records of the pH meter and conductivity meter.

 5.3 Calibration: 

 5.3.1  Turn on the power.

 5.3.2 Press the pH button on the control panel. 

 5.3.3  On the screen, “Select User” will be seen.

 5.3.4 Enter the usage by pressing the UP/DOWN  button.

 5.3.5 Press Enter. 

 5.3.6 Enter the password. 

 5.3.7 Press Enter while the calibration  (buffer) is displayed on the screen.

 5.3.8  The display shows calibration.

 5.3.9 Press Enter. 

 5.3.10  3  and 5-point samples for calibration are displayed on the screen.

 5.3.11. Select a 3-point sample to calibrate.

 5.3.12 Press Enter and select acid, base, or acid-base medium depending on the buffer. 

 5.3.13.  The display shows calibration.

 53.14. Press Enter. 

 5.3.15 Insert the pH electrode into any selected buffer. 

 53.16 Press Enter. 

 5317 Wait for calibration to complete and record the final reading that appears.

 53.18. Repeat the same with the other two remaining buffer solutions. 

 5.3.19 it can be performed for conductivity calibration on the same basis or operation.

 5.3.20 The pH meter and conductivity meter calibration log should be kept properly.

 5.4 Required  solutions:

 5.4.1  Buffer  solution pH: 9.20

 5.4.2 Buffer  solution

 5.4.3  Buffer  solution pH: 4.0

 5.4.4  Solution 0.01 M, 0.001 M, and  0.0005 M Potassium chloride.

 5.5  Limit value:

 5.5.1 ±0.05 for pH  buffer solution

 5.5.2 ±0.1%  of standard  value

 6. Abbreviations: 

 6.1 SOP: Standard Operating Procedure 

 6.2  QC: Quality Control 

 6.3 QA: Quality Assurance 

 6.4 TDS: Total Dissolved  Solids

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