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SOP for Operation and Calibration of Friability Test Apparatus

OBJECTIVE
To lay down the procedure for operation and calibration of friability test apparatus

RESPONSIBILITY
Quality Control Chemist 
QA Chemist

ACCOUNTABILITY
Quality Control Manager
QA Manager.

PROCEDURE: (Operation)
General Cleaning
  • Clean the apparatus free of dust with dry cloth from out side every day.
  • Clean the rotating disc and unloading pan from inside with dry cloth at the start and end of every operation. Wet cloth may be used occasionally if cleaning is not proper with dry cloth but this should follow drying of the inner surface by first wiping with dry cloth and exposure to atmosphere air.
Operation Instructions
  • Ensure that apparatus is properly connected with power supply.
  • Switch on the main switch of power supply.
  • Press MODE key and select count mode.
  • Press SET button and set the RPM to 25 with the help of numerical key’s (0 to 9) & press ENTER Key located on the front side of the instrument.
  • Weigh tablets to be tested and record the weight {W1}.
  • Load the weighed tablets in the drum, close the lid and secure it by tightening he screw and press ENTER and then press START to run test. 
  • After the completion of set rotations, the apparatus will automatically unload the tablets into the tray. Observe the tablets.
  • Dedust the tablets, weigh and record the weight {W2}.
  • Calculate the percentage Friability by the following formula;
  • Dstroy the tested tablets as per SOP

PEOPLE ALSO READ: TABLET FRIABILITY TEST SPECIFICATIONS

Calibration Procedure:
  • Switch on the power supply.
  • Set the RPM to 25 and start the machine simultaneously with the stop watch. Count the actual rotations and note the time required for the same.
  • Similarly set the RPM to 100 and note the time required and actual rotations.
  • Apparatus is in proper working condition if,
  • R Time required for 25 rotations is 1 min ± 05 sec.
    R Time required for 100 rotations is 4 min ± 20 sec.
  • Record the observation in the calibration record as per Annexure – 1.
  • Affix a “Calibration Status” label on the instrument.
  • In case of any discrepancy, report the observations to QC manager / QA Manager and notify the defect to Engg. Department. Affix an ‘UNDER MAINTENANCE” label on the instrument. 
Frequency:
Once in a month and after each maintenance job.


ANNEXURE - 1

REF. SOP NO.: 
Revision No.:  00
Page No. : 1 of 1
Effective from:

 

Name of Instrument:
Instrument ID:
Make & Model:
Calibration Date:
Calibration Due on:

Sr. No.

SET ROTATION

ROTATIONS DISPLAYED

ROTATION OBSERVED MANUALLY

TIME

ACCEPTANCE CRITERIA

1

25

1 min ± 05 sec

2

100

4 min ±  20 sec

 

Remarks: Satisfactory / Not Satisfactory

Calibrated By / Date: ________       Checked By / Date: ____________


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