- To lay down a procedure for calibration of pH Meter.
- This SOP is applicable for calibration of pH Meter in quality control laboratory.
- Officer or above of QC laboratory is responsible for calibration of pH Meter
- Head Quality / nominee of QC department is responsible for reviewing and approval of the SOP
- Head – Quality Control shall be accountable for compliance of SOPs.
- Ensure the cleanliness of the instrument.
- Clean the electrodes with purified water and wipe with tissue paper.
- Dip the electrode in pH-7.0 solution and press the CAL 7 key. The message ‘ENTER IF STABLE ‘will show then press the ENTER key and record the results.
- Dip the electrode in pH -4.0 solution and press the CAL 4 key, the message ‘ENTER IF STABLE’ will show then press the ENTER key .
- Dip the electrode in pH -9.2 solution and press the CAL 9.2 key, the message ‘ENTER IF STABLE’ will show then press the ENTER key .
- The message will show ‘Calibration complete.
- While checking the pH of buffer 4.0, and 7.0 clean the electrode with purified water every time.
- After use keep the electrode dipped in the purified water.
- Calibrate the instrument daily and record the results in the format as per Annexure- I.
- Maintain the preparation and consumption record of pH buffer solution as per Annexure- II.
- If the results of calibration are not conforming to the specified limits report to the department Head for an appropriate action.
List of Annexure
|S.No.||Annexure Title||Annexure Number|
|1||pH Meter Calibration Record||
|2||Preparation and consumption record of pH buffer solution||
- References (if any).
- Not applicable.
- Reason for Revision
- Not applicable due to first version.
Annexure – I
pH Meter Calibration Record
MAKE : MODEL :
|Limit||± 0.05||± 0.05||± 0.05|
Annexure – II
Preparation and consumption record of pH buffer solution
Date of preparation
|Opening Balance||Buffer tablet/Capsules (Qty. used)||Balance Qty.||
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit 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. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube