Fribilator Operational SOP

1.0  OBJECTIVE:

To lay down the procedure for Operation of Friability test apparatus.

2.0  SCOPE:

This shall be applicable to the Friability apparatus of Quality Control Instrument Lab.

3.0  RESPONSIBILITY:

3.1  Technical Assistant/ Helper.

3.2  Q.C Analyst.

4.0  ACCOUNTABILITY:

4.1  Manager-Quality Control.

5.0  MATERIAL AND EQUIPMENT:

5.1  Friabilator.

5.2  Analytical weighing balance.

5.3  Tablets. (Uncoated/ Compressed tablets).

6.0  PROCEDURE:

6.1  How to operate the Machine:

6.1.1        Connect the “Power Plug” to the socket (220V,AC).

6.1.2        Turn ON the “Main Button” which is located at the bottom of right side of the machine, Bulb in the “Main Button” will illuminate.

NOTE: If the bulb does not illuminate, check the main supply.

6.1.3        “LCD” (Liquid Crystal Display) which is located on the front panel of the machine will be illuminated and will show following display.

CURIO                      FB2020+

6.1.4        Press any key from numerical key board, the display will be

1: MODE                    2: SETT

6.1.5        Press “1” for “MODE”. Now display will show

1: REV                        2: TIME ESC

NOTE:

       By pressing 1, Revolution based rotation will be activated and the default value is 25 rev.

       By pressing 2, Time based rotation will be active and the default time is 04 minutes.

6.1.6        Now it depends upon the operator either he/she selects time mode or revolution mode.

      Press ESC if needed to go back to the previous position.

6.1.7        When “REVOLUTION MODE” has been selected, the display will be

REV. = 25 ESC          RUN

If “TIME MODE” has been selected, the display will be

MIN.  = 4: 00 ESC RUN

6.1.8        Press “RUN” key from key board to start clockwise rotation and “ESC” to go back to the previous position. After pressing “RUN” key, count down will start and to stop the rotation press “STOP” key. (If needed).

6.1.9        After completion of the revolution or time, the rotation will stop and there will be a delay of 3 seconds. After 3 seconds the disk will rotate counter clockwise, complete one rotation and will stop. The display will be

Cycle Complete ESC: Continue

6.1.10    Press “ESC” and then “RUN” if it is needed to continue with the same MODE.

6.2  How to change the setting:

Following steps are used to change the setting.

6.2.1        Go back to the STEP 4 of the previous topic. Display will be

1: MODE                    2: SETT

6.2.2        Press “2” for “Setting”. Now display will be

1: SET_R            2: SET_T ESC

6.2.3        Press 1 for “SET_R” (Rotation Setting) or press 2 for “SET_T” (Time Setting) and “ESC” for the previous option.

6.2.4        For revolution setting press 1. Display will be

REV. = 0025 ESC                RUN: SET

6.2.5        Press “RUN” key to set the revolutions. Display will be

REV. = 0025_         ENTER               ESC

6.2.6        Press left (⟵) or right (⟶) arrow key on the screen to shift the digit. The selected digit will start blinking. Input the desired number and press ENTER (⟵) key to save the setting.

6.2.7        For example: To set “50 revolutions”, press the left arrow key (⟵) two times now press 5 from the numerical key board and press 0. Now press ENTER key to save the setting. Display will be       

REV. = 0050 ESC                RUN: SET

Press “ESC” two times and then follow the operating steps.

6.2.8        If change in time is required, go to the “STEP 2” and press “2” for “SET_T” (Time setting). Display will be

TIME = 04 ESC                RUN: SET

6.2.9        Press “RUN” key to set the Time. Display will be

TIME = 04_         ENTER        ESC         ⟶      ⟵

6.2.10    Press left (  ⟵       ) or right (  ⟶       ) arrow key on the screen to shift the digit. The selected digit will start blinking. Input the desired number and press the ENTER ( ⟵ ) key to save the setting.

For example: To set “08 minutes”, press the left arrow key (   ⟵      ) one time now press 8 from the numerical key board and press ENTER (   ⟵        ) key to save the setting. Display will be       

TIME = 08 ESC                RUN: SET

                             

Press “ESC” two times and then follow the operating steps.

6.3  Precautions:

6.3.1        Do not hold the drums while rotating.

6.3.2        After testing destroy the tablets.

6.3.3        Test can be performed by adjusting “COUNT” and “TIME” both.

7.0  REVISION LOG:

Revision No.	Effective Date	Reason
00		New SOP

8.0  REFERENCES:

8.1  Not Applicable.

9.0  ANNEXURES:

9.1  Not Applicable.

10.0    ABBREVIATIONS:

Abbreviation	Expanded Form
SOP	Standard operating procedure
&	And
No.	Number
Ltd.	Limited
QCI	Quality control instrument lab
Q.C	Quality control
B.P	British pharmacopoeia