Procedure for Operation of Film Coating Pan

1. OBJECTIVE
To lay down the procedure for Operation of Film Coating Pan

2. SCOPE
This procedure is applicable to Production, in the coating area of Tablet section

3. RESPONSIBILITY
• Supervisor/ Machine Operator
• Production Pharmacist/ Above

4. SAFETY INSTRUCTIONS
• Normal electrical precautions should be followed.
• In case of power failure, restart the Film Coating Pan after 2 – 5 minutes.
• Wear safety masks and gloves before starting the coating process.
• Make sure that all the parts of machine are dry before start of coating.
• Operator must be present on machine during operation.
• Don’t touch the product without gloves during coating process.

5. PROCEDURE
5.1 Growing procedure is followed as per SOP.
5.2 Production person shall ensure the cleanliness of the machine & area and ‘CLEANED’ label on it.
5.3 Before starting the operation production person get the line clearance from Q.A person and affix the status label with product name, batch details to equipment & area.
5.4 Operation
5.4.1 Check air pressure by passing air through spray gun.
5.4.2 Adjust the spray gun and solenoid valve on L-shaped S.S rod as shown in figure “3”.
5.4.3 Adjust the gun distance (10-12 inch) from tablet bed.
5.4.4 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.
5.4.5 Place tablets in Film Coating Pan after sieving.
5.4.6 Switch ON the blower fan by rotating the Blower Fan Knob in clockwise direction.
5.4.7 Adjust the inlet temperature of pan through Black heating knob rotating in clockwise direction as show.
5.4.8 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.
5.4.9 Switch ON power supply of solenoid valve.
5.4.10 Press Green push button on main controller to start the pan rotation.
5.4.11 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.
5.4.12 Adjust the spray rate as per Manufacturing Control Document by rotating knob on LG pump, either clockwise or anticlockwise direction to increase or decrease the spray rate respectively.
5.4.13 Push “START” button on LG pump in order to start the spraying of coating material.
5.4.14 When coating process is completed, then stop the LG pump by pressing black button.
5.4.15 Switch OFF the power supply of solenoid valve.
5.4.16 Make atomizing and cylinder pressure to zero by rotating the atomizing and cylinder air pressure valve.
5.4.17 Stop the heating of air by rotating the heat knob in anticlockwise direction.
5.4.18 Cool the tablets with blower fan air.
5.4.19 When temperature of tablets reaches to room temperature, then stop the blower by rotating the Blower Fan Knob in anticlockwise direction.
5.4.20 Stop the pan by pressing Red push button.
5.4.21 Transfer coated tablets to polythene bag lined plastic container with the help of S.S bowl.
5.4.22 Clean the nozzle of gun with the help of bottle brush periodically to prevent blockage of gun.
5.4.23 Affix ‘To be Cleaned’ label
5.4.24 Fill the “Machine Usage Log Book”.

6. RELATED DOCUMENTS
Machine Usage Log Book – Annex. I

7. DISTRIBUTION INDEX
Original Copy will be retained by Quality Assurance Department.

8. ABBREVIATIONS
QA Quality Assurance
SOP Standard Operating Procedure
SS Stainless Steel

9. REVISION HISTORY