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List Of SOPs

1.0 PURPOSE:

To provide procedure for operation and cleaning of Coating Machine.

2.0 SCOPE:

This procedure is applicable to operation and cleaning of Tablet Coating Machine at Production Department.

5.0 PROCEDURE:

5.1 General condition & precaution:

5.1.1 Ensure that main electric supply is OFF during fixing of parts.

5.1.2 Visually check the intactness of silicone tubes before fitting.

5.1.3 Ensure that silicone tube fitted inside pump head should not be folded or twisted, before operation.

5.1.4 Both the pressure rollers must be equally released, adjust them by using pressure adjusting screws fixed on them

5.1.5  Avoid touching to the moving parts of the machine during coating.

5.1.6   Wear PPEs during operation and cleaning of coating machine.

5.1.7  Emergency knob is provided on the operating panel to stop the equipment in case of emergency.

5.1.8  Ensure that required compressed air pressure is achieved before operation.

5.2    Prestart up:

5.2.1    Check “CLEANED” label affixed on Coating Pan and ensure that cleaning operation has been recorded with proper identification of type of cleaning i.e. Type- A cleaning/Type -B cleaning.

5.2.2    In case of Type-B cleaning, ensure QC department (if applicable) approves that swab/rinse water sample.

5.2.3 Visually inspect Coating Pan, peristaltic pump and surrounding area for cleanliness.

5.2.4 Ensure that temperature, relative humidity and differential pressure of area are within specified limits.

5.2.5 If the environmental conditions are out of specified limits, inform to Engineering Officer / Executive for corrective action as per current version of respective SOP and start operation only after attaining conditions as per specified limits.

5.2.6  Get line clearance from IPQA Officer / Executive in BMR.

5.2.7  Write the details on “STATUS” label affixed on equipment.

5.3   Set up of peristaltic pump:

5.3.1    Open the tube holder and insert silicone tube while rotating the roller assembly in the same direction till the tube reaches to other tube holder

5.3.2  Switch 'ON' the mains using selector switch provided on operating panel

5.3.3  Display shows maximum RPM. To stop the priming, press 'PRIME' key again.

5.3.4  To set RPM, press either increment key (▲) or decrement (▼) key as per requirement.

5.3.5  Press 'ENTER' key to register the set value.

5.3.6  Set the desired mode of operation in either internal mode/external mode by pressing 'MODE' key.

5.3.7  To start the peristaltic pump in internal mode, press 'START' key and pump shall run at set RPM. Display shows set RPM.

5.3.8  Change the RPM by pressing increment key (▲) or decrement (▼) key as per requirement.

5.3.9 Press 'STOP' key to stop the peristaltic pump.

5.4  Set up of coating pan:

5.4.1    Transfer clean and dried parts to clean coating cubicle.

5.4.2    Fix the parts at their respective position and tighten the hexagonal nuts by rotating in clockwise direction.

5.4.3    Fix the exhaust air plenum at their respective position to the exhaust air duct and tighten the nuts by rotating in clockwise direction.

5.4.4 Fix the coating pan bed temperature/product temperature sensor at its respective position inside the coating pan.

5.4.5   Fix spray guns on retractable arm assembly at respective position properly.

5.4.6 Transfer coating solution storage tank or container near to the coating machine.

5.4.7    Connect the compressed air supply tubes to the pneumatically operated stirrer assembly of the coating solution storage tank and fix the connections properly.

5.4.8    Connect the compressed air supply tubes to the coating/dosing manifold and fix the connections properly.

5.4.9    Check the intactness of silicone tube and connect the one end of silicone tube to the outlet bottom valve of coating solution storage tank/container.

5.4.10  Tighten the lower serrated adjustment wheel while rotating the rotor in clockwise direction and fix the silicone tube between the rollers and track.

5.4.11  Ensure that silicone tube is not twisted or stretched

5.4.12  Clamp the tube firmly by turning the upper serrated adjustment wheel and close the peristaltic pump head guard.

5.4.13  Fix the return silicone tube from the coating/dosing manifold to the tank   its respective position.

5.5   Operation of Coating Machine:

5.5.1 Checking of spray pattern:

5.5.1.1 Remove the spray gun assembly out from the coating pan and cover all the guns with poly bag.

5.5.1.2 Start the peristaltic pump and atomizing air pressure to check the spray pattern in all the guns.

5.5.1.3 Ensure that the angle of spray gun with the tablet bed is perpendicular at the beginning of the process.

5.5.1.4 Set the distance between the spray gun and tablet bed as per Batch Manufacturing Record (BMR).

5.5.1.5 Control width of spray pattern by using atomizing control knob.

5.5.1.6 Turning of the atomizing knob towards clockwise direction gives round spray pattern (cone type).

5.5.1.7 Turning of the atomizing knob towards anticlockwise direction widens the spray pattern (fan type).

5.5.1.8 Ensure that weighing balance and stopwatch are calibrated.

5.5.1.9 Switch ‘ON’ the weighing balance and measure the quantity of the coating solution suspension consumed in 1 minute with the help of stop watch.

5.5.1.10  Spray rate can be expressed in different ways: g/min, g/hr, Kg/min, Kg/hr.

5.5.1.11  Stop peristaltic pump, atomizing air pressure and remove bag.

5.5.1.12 Load the tablets to be coated in the coating pan.

5.5.1.13  Withdraw 100 core tablets and determine the average weight of the tablets or as per procedure mentioned in Batch Manufacturing Record.

5.5.1.14  Push the spray gun assembly into the coating pan.

5.5.2    Operation of coating pan.

5.5.2.1 Transfer the coating solution to be sprayed into the coating solution storage tank/container.

5.5.2.2 Transfer the tablets to be coated to the respective coating cubicle.

5.5.2.3 Switch On the main supply by operating the control ON/OFF selector switch.

5.5.2.4 Start the main motor by operating the main motor start push button.

5.5.2.5 Start Inlet and Exhaust blowers by operating the Inlet / exhaust blower start push button as per parameters mentioned in BMR.

5.5.2.6 Start the heating operation by operating the heating ON/OFF switch.

5.5.2.7 Adjust the temperature on the temperature controller as per parameter mentioned in BMR.

5.5.2.8 Start the spraying by switching on the peristaltic pump as per parameters mentioned in BMR.

5.5.2.9 Record the operation start details in Equipment usage logbook.

5.5.2.10 Check the individual spray gun for proper functioning (without choking) and spray pattern properly

5.5.2.11 Check and record the process parameters like inlet temperature, outlet temperature, atomizing air pressure, pan rpm etc. as per Batch Manufacturing Record

5.5.2.12  Check and record the in process parameters like average weight, thickness and DT of the coated tablets as per BMR.

5.5.2.13 Continue the process till required weight gain is achieved and calculate the weight gain as per BMR

5.5.2.14 After completion of the coating process, remove the spray gun assembly out from the coating pan.

5.5.2.15 Unload the tablets into the HDPE containers containing double poly-bags.

5.5.2.16 Affix the label on the containers and follow the procedure as per Batch Manufacturing Record.

5.5.2.17  Record the operation end details in Equipment usage logbook.

5.5.2.18   Also record the operation start and end details in BMR

5.5.2.19  Stop the pneumatically operated stirrer of coating solution storage tank after completion of the process

5.5.2.20 After completion of the activity switch 'OFF' Main supply on operating panel.

5.5.2.21  Affix “TO BE CLEANED” label to the equipment.

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