1.0 OBJECTIVE:
To
lay down the operation procedure for Film coating pan SS.
2.0 SCOPE:
This
SOP shall be applicable for the operation of Film coating pan SS for tablet coating in Coating Room
of Production department.
3.0 RESPONSIBILITY:
3.1
Supervisor/
Machine Operator.
3.2
Production
Pharmacist & above.
4.0 ACCOUNTABILITY:
4.1
Manager-Production
department.
5.0 MATERIAL AND
EQUIPMENT:
5.1
Film coating pan SS.
6.0 PROCEDURE:
6.1 Operation:
6.1.1
Check air pressure
by passing air through spray gun.
6.1.2
Adjust the spray
gun and solenoid valve on L-shaped S.S rod as shown in figure “3”.
6.1.3
Adjust the gun
distance (10-12 inch) from tablet bed as shown in figure “1”.
6.1.4
Adjust the speed
of coating pan with the help of gear lever by rotating small wheel either
clockwise or anticlockwise and located at the backside of pan.
6.1.5
Place tablets in Film Coating Pan after sieving.
6.1.6
Switch ON the blower fan by rotating the Blower Fan Knob in clockwise
direction as shown in figure “1”.
6.1.7
Adjust the inlet temperature of pan through Black heating knob rotating
in clockwise direction as shown in figure “1”.
6.1.8
After achieving required tablet bed temperature, adjust the atomizing and
cylinder pressure as per Manufacturing Control Document by moving atomizing and
cylinder valve either left or right side respectively.
6.1.9
Switch ON power supply of solenoid valve.
6.1.10 Press Green push button on main controller to start
the pan rotation as shown in figure “1”.
6.1.11 Adjust the pan speed as per Manufacturing Control
Document by rotating Pan Speed Knob clockwise or anticlockwise direction to
increase or decrease the pan speed respectively as shown in figure “1”.
6.1.12 Adjust the spray rate as per Manufacturing Control
Document by rotating knob on LG pump as shown in figure “2”, either clockwise
or anticlockwise direction to increase or decrease the spray rate respectively.
6.1.13 Push “START” button on LG pump as shown in figure
“2” in order to start the spraying of coating material.
6.1.14 When coating process is completed, then stop the LG
pump by pressing black button as shown in figure “2”.
6.1.15 Switch OFF the power supply of solenoid valve.
6.1.16 Make atomizing and cylinder pressure to zero by
rotating the atomizing and cylinder air pressure valve.
6.1.17 Stop the heating of air by rotating the heat knob in
anticlockwise direction as shown in figure “1”.
6.1.18 Cool the tablets with blower fan air.
6.1.19 When temperature of tablets reaches to room
temperature, then stop the blower by rotating the Blower Fan Knob in
anticlockwise direction as shown in figure “1”.
6.1.20 Stop the pan by pressing Red push button as shown in
figure “1”.
6.1.21 Transfer coated tablets to polythene bag lined
plastic container with the help of S.S bowl.
6.1.22 Clean the nozzle of gun with the help of bottle
brush periodically to prevent blockage of gun.
6.1.23 In case of any problem, press the Emergency switch immediately
as shown in figure “1”.
6.2 Precautions:
6.2.1
In case of power
failure, restart the Film Coating Pan after 2 – 5 minutes.
6.2.2
Wear safety masks
and gloves before starting the coating process.
6.2.3
Make sure that all
the parts of machine are dry before start of coating.
6.2.4
Operator must be
present on machine during operation.
6.2.5
Immediately
intimate to Assistant Manager Production/ Production Pharmacist in-case of any
problem.
6.2.6
Don’t touch the
product without gloves during coating process.
6.2.7
After completion
of coating, clean the Film coating pan as per SOP for “Cleaning Procedure of
Film Coating Pan” to make it ready for next batch. In case of light failure,
stop the pump and place S.S bowl below gun to prevent dripping of nozzle on
tablet and switch OFF the power supply to main controller board.
6.2.8
Switch OFF the
power supply of solenoid valve.
6.2.9
Close the air
pressure (atomizing and cylinder pressure).
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
|
|
PMO
|
Production machinery
operation
|
|
F
|
Format
|
|
SS
|
Stainless steel
|