SOP FOR OPERATION AND CLEANING OF FRIABILATOR
1.0 PURPOSE:– To provide a written procedure for operation and cleaning of the Automated Friabilator.
2.0 SCOPE:- Applicable to determine Friability of tablets in Manufacturing.
3.0 RESPONSIBILITY:- Executive Manufacturing,Executive QA and Assistant Manager QA.
4.0 ACCOUNTABILITY:- Manager Quality Assurance
5.0 DEFINITIONS:- Tablet friability can be used to measure efficiency of tabletting equipment or as an indicator of formulation suitability as well as routine QC functions. It can also be thought of as measuring “dusting”. Tablets are rotated in a plastic drum for a specified period of time. A gravimetric determination is then made to quantitate the amount of surface material that has worn off.
6.1.1 Check cleanliness of the equipment.
6.1.2 Switch ON the instrument, drum will initialize itself to the loading position, the display will now show START.
6.1.3 Weigh and record the weight of the tablets.
- For the tablets having individual weight up to 0.650 g take 20 tablets.
- For the tablets having individual weight above 0.650 g take 10 tablets.
6.1.4 Adjust the counts to 100 by pressing the COUNT key followed by ‘1’, ‘0’, ‘0’ keys. (Count range 1 to 99999).
6.1.5 Press ENTER to confirm the reading.
6.1.6 To see and confirm the number of counts press COUNT key.
6.1.7 On confirming the number of counts press RUN/HALT key to start, the display shows the elapsed count.
6.1.8 NOTE: Test can be performed by adjusting ‘TIME’ similarly as ‘COUNT’.
6.1.9 When test is over drum rotates in reverse direction discharging the tablets in the tray.
6.1.10 The test over is indicated by an audible beep and display shows END.
6.1.11 The drum initializes itself to loading position and display shows START indicating the instrument is ready for the next run.
6.1.12 Remove the tablets from the tray.
6.1.13 De- dust and weigh the tablets and note down the weight of the tablets.
Calculate the percentage loss in the weight by using the formula
Percentage Loss =Initial Wt – Final Wt/Initial Wt X 100
• Do not hold the drums while rotating.
- After testing destroy the tablets.
6.2.1 Remove the knob on the shaft by pressing the button.
6.2.2 Pull the outside drum out from the shaft carefully. Similarly remove the inside drum by pulling it outside.
6.2.3 Remove the detachable disc from the drum by pulling it outside of both the drums.
6.2.4 Clean both the drums with clean cloth.
6.2.5 Remove both the trays.
6.2.6 Clean the trays with clean cloth.
6.2.7After cleaning, put the drums and trays back on its position.