PV S1 GO QUALIFICATION OF PH METER.pptx

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1. QUALIFICATION OF PH METER SUBMITTED TO: DR. C. SREEDHAR PROFESSOR AND HOD DEPT. OF PHARMACEUTICAL ANALYSIS KARNATAKA COLLEGE OF PHARMACY BANGALORE SUBMITTED BY: S.GOKULRAJ M PHARM 1 ST SEMESTER (2022-2023) DEPT.OF PHARMACEUTICAL ANALYSIS KARNATAKA COLLEGE OF PHARMACY BANGALORE 1 KARNATAKA COLLEGE OF PHARMACY SUBJECT: PHARMACEUTICAL VALIDATION

2. QUALIFICATION Qualification is a part of validation. It is action of proving and documenting the equipment which are properly installed. Qualification is 4 types they are, Design qualification Installation qualification Performance qualification Operational qualification 2 KARNATAKA COLLEGE OF PHARMACY

3. PH METER A pH meter is an electronic instrument used for measuring the pH (acidity or alkalinity) of a liquid (though special probes are sometimes used to measure the pH of semi-solid substances). A typical pH meter consists of special measuring probes (a glass electrode and a reference electrode) connected to an electronic meter that measures and displays the pH reading. 3 KARNATAKA COLLEGE OF PHARMACY

4. INTRODUCTION TO PH METER PH meter is a electric device used to measure hydrogen-ion activity (acidity or alkalinity) in water based solutions indicating its acidity or alkalinity expressed as pH. It provides a value as to how acidic or alkaline a liquid is. For e g. acids dissolve in water and form positively charged hydrogen ions (H+). The greater this concentration of hydrogen ions, the stronger the acid is. Fundamentally, a pH meter consists of a potentiometer attached to a pH- responsive electrode and a reference (unvarying) electrode. The difference in electrical potential relates to the acidity or pH of the solution. 4 KARNATAKA COLLEGE OF PHARMACY

5. DESIGN QUALIFICATION (DQ) Selection of a manufacturer that can satisfy the needs of the laboratory. Should have ISO 9001 certification. 5 KARNATAKA COLLEGE OF PHARMACY

6. INSTALLATION QUALIFICATION (IQ) Checking of all requirements set during the selection of instrument such as electricity, humidity, temperature, etc. Allowing sufficient shelf space for the equipment, SOPs, operating manuals, etc. Comparing equipment, as received, with purchase order, including accessories, spare parts, etc. Checking documentation for completeness like operating manuals, maintenance instructions, health and safety instructions, Checking equipment for any damage. Reading the supplier's safety instructions, if there are any. Installing hardware following the manufacturer's recommendation. Switching on the pH meter and ensuring that all the modules power up. Preparing an installation report. 6 KARNATAKA COLLEGE OF PHARMACY

7. OPERATIONAL QUALIFICATION (OQ) TEST PROCEDURE ACCEPTANCE LIMITS FREQUANCY REMARKS Calibration with buffer solution at pH 7 and PH 4. Verification with buffer solution at PH 5 or PH 6. <0.005 PH unit Before each unit Buffer solution are commercially available in either tablet or solution form. Some PH meter also have a temperature sensor,which should be calibrated every six months. The electrode should be washed between each measurement and the buffer should be visually checked for cleanliness and absence of microbial growth before each use. 7 KARNATAKA COLLEGE OF PHARMACY

8. PERFORMANCE QUALIFICATION (PQ) A log book is prepared for operators and service technician to record all equipment related activities in chronological order. Parameters to be checked Typical frequency Typical tolerance limit Slope Offset (PH asymmetry) Reference buffer solution Each day of use or before each series of measurements. 95.0 to 105.0% 30mv 0.05pH units 8 KARNATAKA COLLEGE OF PHARMACY

9. THANK YOU 9 KARNATAKA COLLEGE OF PHARMACY