Qualification of Weights and Measures
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The document discusses the qualification of analytical equipment like electronic balances and pH meters. It explains that qualification includes design, installation, operational and performance qualification to ensure equipment is properly installed and functioning accurately. Specific steps for qualifying balances, such as daily calibration checks with internal weights and yearly checks with external weights, are provided. The two-point calibration method for pH meters using buffer solutions is also described. Acceptance limits and record keeping procedures are outlined to ensure equipment remains calibrated over time.
Qualification of Weights and Measures
- 1. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 1 QUALIFICATION OF WEIGHTS AND MEASURES A Seminar as a part of curricular requirement for I year M. Pharmacy II semester Presented by P. PAVAN KALYAN (Reg. No.20L81S0705) Department of Pharmaceutical Analysis
- 2. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 2 • Introduction to Qualification • Electronic Balance • Qualification of Electronic Balance • pH meter • Qualification of pH meter • References contents
- 3. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 3 • Qualification is a part of validation. It is action of proving and documenting the equipment, which are properly installed. • Qualification is of 4 types: 1. Design Qualification 2. Installation Qualification 3. Operational Qualification 4. Performance Qualification INTRODUCTION TO QUALIFICATION
- 4. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 4 ELECTRONIC BALANCE
- 5. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 5 Many types of balances are used in chemical and biological tests. These balances must be calibrated to ensure the accuracy of the data produced by it. Different types of balances used are as follows :-
- 6. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 Requirements of the balance :- It should work under optimal conditions like weighing room, weighing bench, temperature, light, air etc. S.NO REQUIREMENTS ACCEPTANCE 1) Weighing bench Should be non-magnetic vibration proof& dust free 2) Temperature Constant temperature should be maintained. Deviations should not exceed 5°c 3) Atmospheric humidity Should be between 40% to 60% 4) Light Should be protected from directsunlight 5) Weighing vessel Smallest possible weighing vessel used. Weighing vessel and sample it contains should have same temperature. 13
- 7. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 7 Design Qualification :- Selection of a manufacturer that can satisfy the needs of the laboratory Installation Qualification :- 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. QUALIFICATION OF ELECTRONIC BALANCE
- 8. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 8 Checking documentation for completeness like operating manuals, maintenance instructions, health and safety instructions, etc. 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 electronic balance and ensuring that all the modules power up. Preparing an installation report.
- 9. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 T est procedure Acceptance limits T est frequency Remarks • Measurement of reference weight by using 10mg, 50mg, 100mg, 500mg, 1g, 5g, 10g and 20g. • Comparing the actual results with reference weights. 0.1% • Daily or when used, whatever is longer with internal reference weights. • Yearly with traceable external weights through instrument vendor. External standard should be traceable to national standard. Operational Qualification:-
- 10. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 10 Defining weights and weight classes to be used. Defining acceptance limits of results. Defining test intervals. Defining corrective actions on what to do if the electronic balance does not meet the criteria, in other words if the results are out of specification. Performance Qualification:-
- 11. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 11 Calibration of Electronic Balance
- 12. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 12 pH METER
- 13. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 Two Point Calibration Method:- This is the method in which pH meter is calibrated with 2 different buffers of known pH and then checking the pH meter against pH 7.0 standard buffer to confirm the calibration. Again place the tip of the electrode in the second calibration buffer i.e . either in pH 4.0 or 9.2 and repeat the procedure.
- 14. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 PROCEDURE:- Check the level of the 3M KCL electrode filling solution (electrical conductor between reference & sample) to ensure that it is within 25mm of the filling hole (small circular hole on the side of the electrode). Then rinse the probe with de-ionized water & blot dry with wipes & then place the tip of the electrode into the pH 7.0 buffer solution and pH 4.0 buffer or pH 9.2 buffer. The pH meter will automatically read the endpoint when the reading is stable & appropriate buffer symbol will appear on the display and record the pH value.
- 15. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 15 Design Qualification:- Selection of a manufacturer that can satisfy the needs of the laboratory Installation Qualification :- 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. QUALIFICATION OF pH METER
- 16. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 16 Checking documentation for completeness like operating manuals, maintenance instructions, health and safety instructions, etc. 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.
- 17. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 Test procedure Acceptance limits Test frequency Remarks • Calibration with buffer solution at pH 7 and pH 4. • V erification with buffer solution at pH 5 or pH 6. <0.005 pH units Before each use • Buffer solutions are commercially available in either tablet or solution form. • Some pH meters also have a temperature sensor, which should be calibrated every six months. • The electrodes should be washed between each measurement and the buffers should be visually checked for cleanliness and absence of microbial growth before each use. Operational Qualification:-
- 18. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 Performance Qualification:- . Parameter to be checked Typical frequency Typical tolerance limit Slope Each day of use or before each series of measurements 95.0 to 105.0% Offset (pH asymmetry) +/-30mV (offset of manufacturer +/- 0.5 pH units at defined temperature) Reference buffer solution +/-0.05 pH units A log book is prepared for operators and service technicians to record all equipment related activities in chronological order.
- 19. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 Date & Time (DD-MM-YY & am or pm) Observed pH 4.01 Buffer (±0.05) 7.00Buffe r (±0.05) 9.2Buffer (±0.05) Room temp (°C) Cal. Status (Pass/Fail) Calibrated by (Name &Sign) Checked By (Name &Sign) Daily pH meterCalibration
- 20. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 20 Precautions :- Do not allow the filled solution to run dry and add filled solution when ever the level falls 25mm below. Do not leave the electrode in organic solvents as the tip and body may be damaged. Discard used buffer solutions daily. Do not reuse it. Interference :- The electrode can be stored for up to one week in pH 7.0 or 4.0 not in distilled water. For longer storage periods remove the wetting cap and fill it with 3M KCL solution and push it onto the tip of the electrode.
- 21. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 21 • Qualification of Equipment Calibration/Qualification of pH Meters PA/PH/OMCL (13) 86 DEF. • Qualification of balances to the OMCL network Guidelines “Qualification of Equipments” PA/PH/OMCL (12) 77 R11. • P. Bedson, M. Sargent: The development and application of guidance on equipment qualification of analytical instruments. Accred. Qual. Assurance (1996) 1, 265–274 Reference:
- 22. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 22