VALIDATION OF FRIABILITY TEST APPARATUS
(CALIBARATION & QUALIFICATION)
Ram Mohan S.R.
1st M.Pharm
Pharmaceutical Quality AssuranceJSS college of pharmacy
Mysore
OBJECTIVE RESPONSIBILITY & ACCOUNTABILITY
OVERVIEW OF COMPLETE PROCRSS
PROCEDURES
General Cleaning
Operating Instructions
Calibration Procedure
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OBJECTIVE
To lay down the procedure for operation and
calibration To qualify to get accurate results
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RESPONSIBILITY & ACCOUNTABILITY
RESPONSIBILITY
Quality Control Personal Quality Assurance Personal
ACCOUNTABLITY
Quality Control Manager Quality Assurance Manager 23-01-2015 4
OVERVIEW OF COMPLETE PROCRSS
Calibration Data of instrument to be calibrated
Operative condition of control points and alarms
List of calibration requirements for the system
Record any deviation to the procedure performed
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Record any deviation to the procedure performed and impact on operation
Prepare detailed Operation Qualification report Date
Study plan
Data collected
Observations
Encountered problems
Summery of deviation
Conclusion
Submit to QA for review and approval23-01-2015 6
GENERAL CLEANING
Clean the apparatus to make it dust free with dry
cloth everyday .
Clean rotating disc and
unloading pan with dry cloth at
the start and end of process.
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OPERATING INSTRUSTIONS
Ensure that the apparatus is properly connected with power supply.
Weight the tablets to be tested and record the weight. (W1)
Switch on the instrument.
Press MODE key and select count mode.
Press SET button and set the RPM and press enter.
Load the previously weighed tablets in the drum , press ENTER and then press START to run test.
After the completion of test Dedust the tablet and record the weight. (W2).
Calculate the percentage Friability by formula. W1-W2×100W1
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CALIBRATION
SL NO PARAMETER STANDARD VALUE
OBSERVED VALE LIMITS REMARKS
1 COUNT50 Revaluations / 2 minutes
2 minutes49-51
2 COUNT100Revaluations / 4 minutes
4 minutes 98-102
3 COUNT150 Revaluations / 6minutes
6 minutes 147-153
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TIME REVOLUTIONS