1.0 OBJECTIVE:To lay down the procedure for Operation and Calibration of Friability test apparatus.
2.0 SCOPE:This SOP shall be applicable to Quality Control Dept.
3.0 RESPONSIBILITY:Supervisor Quality Control
4.0 ACCOUNTABILITY:Sr. Manager Quality Assurance
5.1 Operation:5.1.1 Weigh the specified number of tablets for the test.
5.1.2 Remove the acrylic cover of the drum and place the tablets inside the drum.
5.1.3 Replace the cover and tighten with the help of plastic knob taking care not to tighten the knob excessively as the drum and threading may get damaged.
5.1.4 Switch on the Main power supply; the display shall show "VEEGO FRIABILITY TEST APPARATUS" for few seconds.
5.1.5 Then the display shall show “ENTER-START PROGRAM, INC-PROGRAM"
5.1.6 To start the test press, "ENTER" key. The display shall show the set rotations.
5.1.7 Then press the "START" key, display shall show both Set and Actual rotations.
5.1.8 When the actual rotations reach the Set rotations, the drum shall stop rotating along with a beep sound.
5.1.9 Take out the tablets from the drum by removing the cover.
5.1.10 Weigh the tablets again and determine the loss in weight, calculate the percentage.
Related: Friability of Uncoated Tablets
5.2 Procedure to Set Rotations:5.2.1 Follow above procedure till step 5.
5.2.2 Then press "INC" switch.
5.2.3 Display shall show "SET ROTATIONS 0000", and the last digit shall be blinking.
5.2.4 Press "INC" switch till the last digit reaches desired figure.
5.2.5 Then press the "ENTER" key.
5.2.6 The third digit shall start blinking.
5.2.7 Continue as per steps 4 and 5 till value is set for each digit.
5.2.8 The display shall return to “ENTER-START TEST, INC-PROGRAM".
5.3 Calibration:5.3.1 First of all clean the instrument and the drum.
5.3.2 Switch on the mains of the instrument.
5.3.3 Set 100 rotations.
5.3.4 Calibrate the revolutions per minute manually by watch. Record the reading difference and note down in following calibration format.
5.3.5 Acceptable limits are given in the calibration format and if any deviations are observed, hang the tag " Out of order", call the party or service engineer.
6.0 ABBREVIATIONS:6.1 SOP : Standard Operating Procedure
6.2 QA : Quality Assurance
6.3 QC : Quality Control
6.4 Dept. : Department
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