SOP for Operation and Cleaning of Manual Coating Machine

OBJECTIVE

To provide a procedure for the operation and cleaning of the Coating machine.

SCOPE

It applies to the operation and cleaning of the Coating machine located in the Production area.

RESPONSIBILITY

Operator: To operate and clean the equipment as per this procedure.

Supervisor: To ensure that the SOP is followed.

PROCEDURE

Operation of Coating Pan:

• Ensure the Cleanliness of the Coating machine before use. Make sure the coating pan is dry.
• Load the de-dusted and inspected tablets in the Coating pan as per the quantity mentioned in the BMR.
• Close the lid of the Pan.
• Switch on the mains and Start the rotation of the Pan by pressing the ‘START’ button for Pan rotation on the control panel. Set pan rotation RPM as mentioned in BMR.

• Start the Inlet and Exhaust Air Blower.
• Switch on the heaters and set the temperature from Control Panel as stipulated in the BMR.
• Allow the Coating pan to rotate during the Coating, drying and finishing process.
• Start the peristaltic pump to do the Spraying on tablets. At the first step, atomizing air pressure should be supplied at the Spray gun and after that coating, the solution supply should start.
• At the end of the process, Stop the peristaltic pump and stop the supplying coating solution at the spray gun and after that stop the Atomizing air supply.
• Switch off electrical heaters after that stop Inlet and Exhaust air blower.
• Stop the Pan rotation by pressing the ‘STOP’ button on the control panel.
• Unload the coated tablets manually from the coating pan ensuring that the tablets and the pan are not damaged.
• Repeat the same procedure for other lots of tablets.

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Operation of Spraying Unit:

• Ensure the cleanliness of the Spraying Unit. Make sure the unit is dry before use. Use a dry lint-free cloth to wipe.
• Assemble the unit (if it is dismantled). Connect all the pneumatic air lines for FR to the motor and spray gun. Also, connect the liquid line from the tank to the spray gun through the peristaltic pump.

• Adjust the angle, height, and location of the gun, through the arrangements provided for the adjustments.
• Adjust the operating air pressure required for the operation (as mentioned in BMR) through the FR unit. Also, the spraying air pressure can be adjusted through the trigger level of the spray gun, which can be locked at any place through the clamp.
• Make sure that all the liquid connections are proper and stiff.
• Now switch ‘ON’ the peristaltic pump through the key provided at the back of the pump.
• Adjust the direction of rotation of the pump as per the inlet and outlet connections, i.e. clockwise or anticlockwise direction.
• Adjust the flow of the liquid from the pump, through the rotary knob at the front panel of the pump, i.e. regulating the speed of the pump.
• Normal / Priming toggle key can be used if the priming of the pump is required at an earlier stage for lifting the liquid from the tank to the gun quickly.
• The front nozzle of the gun can also be adjusted to get the desired form and shape of spraying.
• At the end of the process stop the pump, first by switching ‘OFF’ switch and last stop the air supply for the FR unit.

Cleaning:

• Dismantle the Spraying Unit from the coating pan.
• Use raw water and a Soft cleaning agent (if required) to clean the Coating pan.
• Add Raw water to the Coating pan and continue pan rotation for about 15 minutes. In case of enteric coating use 20% w/v sodium hydroxide and rotate the pan for 10 – 15 minutes.

• Stop the pan and remove the water from the pan. Ensure no debris of previous batch processing remains in the pan. Rinse with purified water.
• Switch on the inlet/exhaust blower and pan rotation to dry the coating pan.
• Finally, wipe with 70% IPA.
• Spray water through a peristaltic pump to remove the remains of the coating solution in the pipe and spray gun.
• Dismantle the spray gun and clean it thoroughly with Raw water and a soft cleaning agent (if required). Rinse with purified water.
• Clean the solution tank with Raw water and a soft cleaning agent (if required). Rinse with purified water. Dismantle the baffles from the tank and similarly clean them.
• Finally wipes all the components of the Spraying Unit with 70% IPA and assembles the parts to make it ready for operation.

ABBREVIATIONS

SOP: Standard Operating Procedure.

BMR: Batch Manufacturing Record.

FR: Filter Regulator.

IPA: Isopropyl Alcohol.

REVISION HISTORY

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