Tablet Coating Machine, Purpose:
Tablet Coating Machine, The purpose of this SOP is to describe the setting, operation and cleaning procedure of Tablet Coating Machine (Model: FC-39) in order to comply with cGMP standard.
Tablet Coating Machine, Scope:
The scope of the procedure is applicable to the Tablet Coating Machine (Model: FC-39) at the Production area of XX Pharmaceuticals Limited.
Definitions / Abbreviation:
[][]PLC : Programmable Logic Controller.
[][]CIP : Clean In Place.
Responsibilities:
[][]The Roles and Responsibilities are as follows:
Operator
[][]Setting, operation and cleaning of the Tablet Coating Machine (Model: FC-39)
[][]Maintaining Equipment Log Book
Executive, Production
[][]To monitor and check the laid down procedure.
Manager, Production
[][]To implement this correctly
Manager, Quality Assurance
[][]To approve the Document
Procedure: Tablet Coating Machine
Precaution:
[][]Ensure the outlet duct is open.
[][]Ensure the inlet duct is open.
[][]Keep the doors closed during operation and after completion of job.
[][]Check air pressure.
[][]Use face mask, rubber gloves and protective clothing during handling of materials.
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.
[][]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.
[][]Pan motor ‘‘ON/OFF’ from the PLC.
[][]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.
[][]Record the machine operation start time & end time and other parameters on the ‘Equipment Log Book’
Machine Dismantling
[][]Remove the spray system and dismantle.
[][]Remove the pan outlet dumber.
Machine Cleaning: Tablet Coating Machine
[][]Switch off outlet damper, outlet blower, pan motor.
[][]Open all safety doors.
[][]Switch on the peristaltic pump by pressing “Switch on button”.
[][]Wash the inside of tube by spraying with hot water.
[][]Then wash the tube with purified water.
[][]Pass 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 through CIP system to remove materials fixed hardly on the chamber surface.
[][]Re-wash the machine with purified water as required through CIP system.
[][]Wash the machine with lint free cloth.
[][]Clean inlet ports, discharge port, mixing chamber and external surface with potable water, hot water & purified water.
[][]Wipe the water droplets with lint free cloth, and dry the machine with compressed air.
[][]After final cleaning affix the ‘CLEANED’ label.
[][]Record the cleaning parameters on the ‘Equipment Log Book’
Annexure:
Annexure I Equipment Use Log Book