Pharmaceutical validation

1. Qualification of
Electronic Balance
Presented by,
R.Venkatesan.
M.Pharm 1st 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
1. Introduction
2. Types of qualification
3. 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:
1. Design qualification (Before purchasing)
2. Installation qualification (After purchasing to install the equipment)
3. Operational qualification (Operate the equipment to check working)
4. Performance qualification (complies its specification)
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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.
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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 :-
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7. It should work under optimal conditions like weighing room, weighing bench,
temperature, light, air etc.
1.Weighing bench – should be non magnetic vibration proof and dust
free.
2.Temperature – constant temperature should be maintained. deviation
should not exceed 5o C.
3.Atmospheric humidity – Should be between 40% to 60%.
4.Light – should be protected from direct sunlight.
5.Weighing vessel – smallest possible weighing vessel used. Weighing
vessel and sample it contains should have same temperature.
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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.
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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.
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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
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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.
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13. THANK YOU