1. OBJECTIVE

1.1 To lay down a procedure for operation of Friabilator, Make: Electro lab

2.0       RESPONSIBILITY

2.1 Technical Assistant / Production Executive / IPQA Executive – To Perform as per SOP.

2.2 Production / IPQA In-charge – To ensure the compliance.

3.0 PROCEDURE

3.1   OPERATION :

3.1.1     Switch ON the mains.

3.1.2    Press the START/STOP switch on the rear right hand side of the instrument base, then the drum will initialize itself to the loading position and simultaneously display shows START.

3.1.3 Mode setting – TIME, COUNT key are toggle keys to set in Timer mode or Count mode of operation.   3.1.4   Set the Time in the following procedure:

 3.1.4.1  Press “RESET” key.

 3.1.4.2  Press “TIME” key.

 3.1.4.3  Enter the required duration of time by pressing the numeric digits.

 3.1.4.4  Press “ENTER” key to set the time.

3.1.5     Set the Count in the following procedure:

  3.1.5.1  Press “RESET” key.

  3.1.5.2  Press “COUNT” key.

  3.1.5.3  Enter the desired number of rotations by pressing the numeric digits.

 3.1.5.4  Press “ENTER” key to set the count.

 3.1.5.5  After completing the parameter settings, slide the tablets gently into the drum from the side slit provided on the drum. 

3.1.5.6  Select the Time mode or Revolution count mode as desired by pressing the “TIME / COUNT” key respectively.

PRECAUTIONS:

1. Make sure the knob is properly fitted on the shaft to assure the drum is held in position.
2. Do not hold the drums while they are rotating.

3.1.6 Weigh the quantity of tablets to be tested as per the BPRR specification from LHS and RHS of compression machine.

3.1.7 Record the weights of tablets in BPRR if provided and load the tablets to  friabilator drum.

3.1.8 Press “RUN / HALT” key to start the test.  “RUN / HALT” is a toggle key to start and stop the test.

3.1.9 Drums rotate in forward direction as per the set (TIME/COUNT) mode.

3.1.10 Completion of test is indicated by an audible beep and the display shows “END”.

3.1.11 When the test is over, the drums rotate in the reverse direction for discharging the tablets into the trays.  After discharge of tablets drums initialize to loading position and the display shows “START” indicating the instrument is ready for next test.

3.1.12 Slide out the tray and take out the samples for weighing.

3.1.13 Dedust the tablets using nylon brush, weigh and record  in BPRR.

3.1.14 Calculate and record the friability as per BPRR.

Note:

1. If tablet size or shape causes irregular tumbling, adjust the drum base so that the base forms an angle of about 10⁰ with the table surface and the tablets no longer bind together when lying next to each other, which prevents them from falling freely.
2. Adjustment of the drum base can be done by opening the two flaps, which are situated at the front bottom side of the instrument.

3.2    CLEANING :

3.2.1     Clean the Friabilator frequently by following procedure.

3.2.2     Switch off the power supply to the instrument before cleaning the equipment.

3.2.3     Remove the trays in the tray holders.

3.2.4     Remove the drums from the shaft by pressing the button on the knob and pull   out  the knob.

3.2.5 Clean the drums, trays and knob with lint free cloth dipped purified water and wipe with dry lint free cloth.

3.2.6 Wipe off the exterior of the equipment with lint free wet cloth.

3.2.7 Reassemble the drums and tray in the reverse order of dismantling.

3.2.8 Update the status label as CLEANED.

3.2.9 Switch off the mains of the tablet friability apparatus after the days operation.

Frequency   :   After every batch irrespective of product, or Weekly (if machine is in

operation), or Monthly (if machine is idle) which ever is the earlier and as and when   required.

4.0       ABBREVIATIONS

Nil

5.0       REFERENCES

Nil

6.0       ANNEXURES

Nil

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