SOP for Operation & Cleaning of Auto Coater

OBJECTIVE

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

SCOPE

It is applicable to the operation and cleaning of auto-coating machines 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.

IPQC personnel: To verify that Operation and cleaning is followed as per SOP.

PROCEDURE

Operation of Coating Pan

• Ensure Cleanliness of the Coating machine before use. Make sure the coating pan is dry.
• Switch on the main switch, log in with the password
• Switch on atomizing air and seal the Gasket of the pan.
• Load the de-dusted and inspected tablet in the coating pan as per the quantity mentioned in the BMR
• Close the lid of the Pan.

• Press the manual switch, start the exhaust blower/inlet blower, and Switch on the damper.
• Switch on the steam heater set the temperature mentioned in the batch record, and wait for some time to achieve the inlet temperature of the pan. Heat the tablet for some time.
• Switch on the pan, set the (RPM) of the pan, and initially make less rotation.
• Switch on the stirrer of the solution tank, stirrer must be on until finish of spraying.
• Start spraying of solution and Spraying on tablets, set the spray rate of the solution at the first step atomizing air pressure should be supplied at the Spray gun, and after that coating solution supply should start.
• Allow the Coating pan to rotate during the Coating, drying, and finishing process.
• At the end of the process, Stop the Spray and stop the supply of coating solution at the spray gun and after that stop the Atomizing air supply.
• Stop the inlet of hot air from the boiler. After that stop Inlet and Exhaust air blower.
• Stop the Pan rotation by pressing ‘SWITCH OFF’ 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 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 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 pump through the Spray on.
• 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 by adjusting the spray rate from the pump, through the rotary knob at the front part of the machine. 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 the ‘SPRAY OFF’ switch and last stop the air supply.

Cleaning

• Dismantle the Spraying Unit from the coating pan.
• Use raw water and 1% soap solution (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 Residue from the previous batch remains in the pan. Rinse with purified water.
• Switch on the inlet/exhaust blower and pan rotation to make the coating pan dry.
• 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 1% soap solution (if required). Rinse with purified water.
• Clean the solution tank with Raw water and 1% soap solution (if required). Rinse with purified water. Dismantle the baffles from the tank and clean in a similar manner.
• 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.

RRM: Revolution Per Minute

REVISION HISTORY

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