Operating, Cleaning and Calibration Procedure for Friability Tester

1. OBJECTIVE
To lay down the procedure for operation of Friability Tester
2. SCOPE
This procedure is applicable to Quality Control Department
3. RESPONSIBILITY
• Officer QC
• Manager QC

4. SAFETY INSTRUCTIONS
• Don’t switch on the main board with wet hands

5. PROCEDURE

5.1 OPERATION
5.1.1 Weigh the specified number of tablets for the test.
5.1.2 Remove the cover of the drum, place the tablets inside and put the cover.
5.1.3 Switch on the main supply.
5.1.4 Press the button “START”
5.1.5 After completion of 4mintues press the red color “Reverse Button”.
5.1.6 The drum will be emptied in the bin.
5.1.7 Remove the bin and weigh the tablet.
5.1.8 Note the weight.
5.1.9 Calculate the weight loss by using this formula:
Friability = (W1 – W2)/W2 x 100

5.2 CLEANING
5.2.1 After completion of friability test, switch “OFF” the instrument
5.2.2 Switch off the main power supply
5.2.3 Remove the knob and remove the lid of dram
5.2.4 Clean the lid and drum with tissue paper and make it visually clean.
5.2.5 Remove the wastage tray, wash it and dry it
5.3 CALIBRATION
5.3.1 Switch on the power
5.3.2 The drum will initialize itself to the loading position at the power ON.
5.3.3 Display will show “Start”
5.3.4 After weighing sample slide the tablets gently into the drum from the side slit provided on the drum.
5.3.5 Switch on your stop watch
5.3.6 Press the start button of friability tester and stop watch at a time
5.3.7 Stat to count the revolutions of drum
5.3.8 Note down the revolutions in the log book Annexure –II
5.3.9 It should be 50 rev/2 minutes and 100 rev/4 minutes

6. RELATED DOCUMENTS
Operational Log Book Format – Annex. I
Cleaning Log Book Format – Annex. II
Calibration Report Format – Annex. III

7. DISTRIBUTION INDEX
Original Copy will be retained by Quality Assurance Department.

8. ABBREVIATIONS
Q.C Quality Control Department
SOP Standard Operating Procedure

9. REVISION HISTORY