SOP For Operation of friability apparatus

1.0 OBJECTIVE

To define the procedure for the operation and calibration of the friability test apparatus used in tablet testing.

2.0 SCOPE

This Standard Operating Procedure (SOP) applies to the Production department.

3.0 RESPONSIBILITY

The Production Supervisor and operator is responsible for carrying out this procedure.

4.0 ACCOUNTABILITY

The Senior Manager of production is accountable for ensuring the procedure is followed as outlined.

5.0 PROCEDURE

5.1 Operation

5.1.1 Accurately weigh the required number of tablets for the friability test equivalent to 6.5 grams if the tablet weight is less than or equivalent to it 650 mg, if >650mg take 10 Whole tablets.
5.1.2 Remove the drum’s acrylic cover and place the tablets inside.
5.1.3 Secure the cover back in place using the plastic knob, avoiding overtightening to prevent damage to the drum or threads.
5.1.4 Turn on the main power supply, and the display will show the apparatus name.
5.1.5 The display will prompt with “ENTER-START PROGRAM.”
5.1.6 Press the “ENTER” button to begin the test, and the display will show the set number of rotations.
5.1.7 Press the “START” button, and the display will show both set and actual rotations.
5.1.8 Once the actual rotations reach the preset value, the drum will stop, accompanied by a beep.
5.1.9 Remove the tablets from the drum by taking off the cover.
5.1.10 Weigh the tablets again and calculate the percentage weight loss to determine the friability.

5.2 Procedure to Set Rotations

5.2.1 Follow the operation procedure until step 5.
5.2.2 Press the “INC” button.
5.2.3 The display will show “SET ROTATIONS 0000,” with the last digit blinking.
5.2.4 Use the “INC” button to adjust the last digit to the desired value.
5.2.5 Press the “ENTER” button to confirm.
5.2.6 The third digit will begin blinking.
5.2.7 Continue setting each digit until the desired number of rotations is achieved.
5.2.8 The display will return to the “ENTER-START TEST, INC-PROGRAM” screen.

5.3 Calibration

5.3.1 Clean the apparatus and the drum thoroughly before calibration.
5.3.2 Turn on the power to the instrument.
5.3.3 Set the drum to 100 rotations.
5.3.4 Manually observe and count the number of revolutions per minute. Record any discrepancies in the calibration log.
5.3.5 Ensure the readings are within acceptable limits as specified in the calibration log. If any deviations occur, mark the instrument as “Out of Order” and contact the service engineer for repairs.

6.0 ABBREVIATIONS

• SOP: Standard Operating Procedure