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
|