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

PROCEDURES

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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

DEVIATION CONCLUSION REPORT

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qualityassurancepharma.blogspot.com

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