ELECTONIC BALANCE

Pharmaceutical validation

1. Qualification of Electronic Balance Presented by, R.Venkatesan . M.Pharm 1 st semester Dept. pharmaceutical analysis Karnataka college of pharmacy Bangalore 03-Mar-2023 Presented to, Dr.C.Sreedhar , Professor and HOD Dept. pharmaceutical analysis Karnataka college of pharmacy Bangalore ADVANCED PHARMACEUTICAL ANALYSIS

2. Content Introduction Types of qualification Qualification of electronic balance

3. INTRODUCTION TO QUALIFICATION Qualification is a part of validation. It is action of proving and documenting the equipment, which are properly installed. Qualification is of 4 types: Design qualification (Before purchasing) Installation qualification (After purchasing to install the equipment) Operational qualification (Operate the equipment to check working) Performance qualification (complies its specification) KARNATAKA COLLEGE OF PHARMACY 3

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5. Electronic balance A piece of lab equipment that is used to precisely measure the weight of materials is called an electronic balance. The use of electronic balance includes scientific and pharmaceutical research, bakeries, and chemical laboratories. KARNATAKA COLLEGE OF PHARMACY 5

6. Many types of balances are used in chemical and biological test these balances must be calibrated to ensure the accuracy of the data produced by it. Different types of balances used are as follows :- KARNATAKA COLLEGE OF PHARMACY 6

7. It should work under optimal conditions like weighing room, weighing bench, temperature, light, air etc. Weighing bench – should be non magnetic vibration proof and dust free. Temperature – constant temperature should be maintained. deviation should not exceed 5 o C. Atmospheric humidity – Should be between 40% to 60%. Light – should be protected from direct sunlight. Weighing vessel – smallest possible weighing vessel used. Weighing vessel and sample it contains should have same temperature. KARNATAKA COLLEGE OF PHARMACY 7

8. 1.DESIGN QUALIFICATION:- Selection of a manufacture that can satisfy the needs of the laboratory. 2. INSTALLATION QUALIFICATION:- Checking of all requirements set during the selection of instrument such as electricity, humidity and 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. KARNATAKA COLLEGE OF PHARMACY 8

9. Checking documentation for completeness like operating manuals, maintenance instructions, health and safety instructions, etc. Checking equipment for any damage. Reading the suppliers safety instructions, if there are any. Installing hardware following the manufacturers recommendation. Switching on the electronic balance and ensuring that all the modules power up. Preparing an installation report. KARNATAKA COLLEGE OF PHARMACY 9

10. TEST PROCEDURE ACCEPTANCE LIMITS TEST FREQUENCY 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. 3.OPERATIONAL QUALIFICATION KARNATAKA COLLEGE OF PHARMACY 10

11. 4.PERFORMANCE QUALIFICATION :- (complies with predefined specification) 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. KARNATAKA COLLEGE OF PHARMACY 11

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