1.0 OBJECTIVE: To lay down a procedure for cleaning, operation, and calibration of friability test apparatus.
2.0 SCOPE: This procedure is applicable to the cleaning, operation, and calibration of the friability test apparatus used in pharmaceutical manufacturing.
3.0 RESPONSIBILITY: Officer, Executive – Production Department
Manager – Production Department, QA Officer – In the process
5.0 PROCEDURE:
5.1 Cleaning
5.1.1 Remove the acrylic drums by pressing the knobs provided.
5.1.2 Remove the tablet-collecting tray by pulling it outside.
5.1.3 Dry-clean the equipment and acrylic drums using a dry lint-free cloth.
5.1.4 Fix the drums with the cover to the equipment.
5.2 Operation
5.2.1 Ensure that the equipment is cleaned.
5.2.2 Put the power supply ON.
5.2.3 Display will show ‘’START’’.
5.2.4 Setting of time
5.2.4.1 Press the ‘’ TIME’’ button.
5.2.4.2 Set the time to 4 minutes from the numerical button on the panel.
5.2.4.3 Press the ‘’ENTER’’ button, the display will show ‘’ 0.00.00’’ on the screen.
5.2.5 Setting of counts
5.2.5.1 Press the ‘’COUNT’’ switch.
5.2.5.2 Set the count to 100 from the numerical buttons on the panel.
5.2.5.3 Press the ‘’ENTER’’ button, then the display will show ‘’ 00000’’ on the screen.
5.2.6 Take the initial weight of the tablets.
5.2.7 Load the weighed tablets in the slit provided in the drum.
5.2.8 Switch on the apparatus.
5.2.9 After completion of 100 rotations, the equipment will stop, and the tablets go to the tray provided automatically.
5.2.10 Take out the intact tablets and remove any loose dust with the help of a soft brush and then weigh it.
5.2.11 Calculate the friability as per the following formula and enter the same in BMR.
Initial weight-final weight X 100/ Initial weight
5.2.12 Put off the power supply.
5.2.13 Clean the equipment as per point no.: 5.1.
5.3 Calibration
5.3.1 Paste the RPM counting sticker on the drum.
5.3.2 Operate the instrument as per point no. 5.2.
5.3.3 Set the rotation control button at 25 rotations and start the instrument.
5.3.4 Count the number of rotations in one minute manually by using calibrate stopwatch or a calibrated digital tachometer and record the observations in annexure-I.
5.3.5 Repeat step no. 5.3.3 and 5.3.4 for 50 and 100 set RPM.
5.3.6 Affix calibration status label duly filled and signed on the equipment.
5.3.7 In case of any discrepancies observed, affix the ‘UNDER MAINTENANCE’ status label, and inform the department head and engineering department of corrective action. 5.3.8 Do not use the friability apparatus till the problem is rectified.
5.3.9 After rectification, re-calibrate the friability apparatus and enter the same in Annexure-I.
5.3.10 Note: Repeat the same operation with the fresh tablet if the power is a failure in between operations.
Related Post: Tablet Friability Test Calibration and Specification
6.0 ABBREVIATION(S):
QA: Quality Assurance
SOP: Standard Operating Procedure
RPM: Rotations Per Minute
8.0 ANNEXURE(S):
ANNEXURE – I: Friability test apparatus calibration record.
| Set Revolution | No. of Revolution performed | LED Display at stop position | Revolutions per minute (Limit: 25 ± 1) | |
| Count | Time taken | |||
| 25 | ||||
| 50 | ||||
| 100 |
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