Coating pan SS operation SOP

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: