| Operation and Calibration of Friability Test Apparatus |
1.0 OBJECTIVE 1.1 To lay down the procedure for operation and calibration of friability test apparatus. 2.0 SCOPE 2.1 This SOP is applicable for operation and calibration of friability test apparatus in quality control department. 3.0 RESPONSIBILITY 3.1 QC – Chemist / Officer / Executive 4.0 ACCOUNTABILITY 4.1 Head-QC 5.0 PROCEDURE 5.1 Ensure the platform is clean and dry. 5.2 Ensure the instrument is clean and dry. 5.3 Switch “ON” the main power supply. Then initialization display will appear. 5.4 A program is added or edited by entering the sample name and the mode (time or count) is selected. 5.5 Weigh the tablets (W1). Feed the weighed tablets from the slot in the drum and enter the weight in grams. 5.6 Select the Time mode by pressing “TIME”. 5.7 Then enter time (00:04 min) and press ‘ENTER’, Press ‘RUN’. The drum will start rotating. When the test is over, drum will discharge the tablets in the tray. Examine the tablets and remove chipped and capped tablets portion and weigh the degusted tablets. Enter the weight (W2) and press enters, the machine will calculate the percentage and it will display in the screen. 5.8 NOTE: Record all the result in the analytical result form. 5.9 Note down the entry for using the instrument in the instrument logbook. 5.10 For tablets with an average weight of 0.65g or less; then take a sample of complete tablets corresponding to about 6.5g and for tablets with an average weight more than 0.65g; take a sample of 10 complete tablets. 5.11 Calibration: Note down the number of revolutions per minute with the help of calibrated stop watch. 5.12 Frequency: Every four month. |
