Coating Machine , Purpose:
Coating Machine , The purpose of this SOP is to define the operation and cleaning procedure of Coating machine.
Coating Machine , Scope:
This SOP is applicable for operation and cleaning procedure of Coating machine in product development of General Block at XX Pharmaceuticals Limited.
Definition / Abbreviation:
None
Responsibilities:
The roles and responsibility are as follows:
Operator/Supervisor Product Development
[][]Operation and cleaning of the Coating machine
[][]Maintaining operation and cleaning log book
Executive/ Senior Executive, Product Development
[][]Checking and ensuring that the operation and cleaning is performed according to the SOP.
[][]Checking the log book.
[][]Preparation and timely review of the SOP.
Manager, Quality Assurance
[][]Ensure that the SOP reflects actual operation and cleaning procedure.
[][]Approve the SOP against XX Pharmaceuticals Limited master documents and current regulatory requirements.
[][]Implementation of the SOP.
Procedure
[][]Machine Assembling
[][]Before operation assemble the machine accessories that are necessary for operation.
[][]Place the spray gun at the holding arm. Then, enter the spray gun holding arm into the coating pan.
[][]Connect the peristaltic pump with the spray gun.
[][]Test whether coating pan rotates smoothly without any abnormal noise after activation. Check that rotation direction is correct.
Machine Operation
[][]Connect the power cable to the socket for power supply.
[][]Switch on the Machine.
[][]Unlock and open the inlet port cover of the machine.
[][]Load tablets into the coating pan. Total tablet load should not exceed the maximum working load and should not be less than the minimum working load.
[][]Securely close the coating pan chamber cover and clamp.
[][]Outlet blower ‘‘ON/OFF” by pressing the push button.
[][]Pan motor ‘‘ON/OFF’ by pressing the push button.
[][]Inlet blower” ON/OFF” by pressing the push button.
[][]Warm up the tablets without spraying on the tablet bed.
[][]Start spraying phase by pressing the pump start button in manual mode or Spray key in Auto mode. Adjust dosing volume by changing the rpm of the peristaltic pump.
[][]After spraying, stop the Spray by pressing Pump ON/OFF button. Dry the tablets until required
[][]Unload the tablets from the coating pan when desired tablet temperature is attained.
Machine Cleaning
[][]If the machine doesn’t used within 15 days after cleaning, then the machine should be cleaned on the 15th day.
[][]Switch off outlet damper, blower, pan motor, inlet blower.
[][]Open all safety doors.
[][]Dismantle spray system.
[][]Switch on the peristaltic pump by pressing “Switch on button”.
[][]Wash the inside of tube by spraying with hot water followed by purified water.
[][]Again wash the tube with purified water.
[][]The compressed air through tube to dry inside of tube.
[][]Clean the Spray gun nozzle with hot water and soft brush.
[][]Now discharge the water with dissolved materials.
[][]Now hot water is applied inside the chamber to remove materials fixed hardly on the chamber surface.
[][]Wash the machine with wet markin cloth.
[][]Re-wash the machine with purified water as required. Finally rinse with purified water.
[][]Clean inlet ports, discharge port, mixing chamber and external surface with damp cloths.
[][]Wipe the water droplets with cloth, and dry the machine with compressed air.
[][]Fix ‘CLEANED’ label on the machine.
[][]Keep the record of machine operation and cleaning according to the Annexure – I of this SOP.
Annexure:
Annexure – I: Operation and cleaning log sheet of Coating machine, Model: FC 15”-E