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SOP for Automatic Coating System (NEOCOTA 48”)


Standard operating procedure of Automatic Coating System used for coating on tablet.

1.0  OBJECTIVE:

       To lay down the procedure for Operation of Automatic Coating System (NEOCOTA 48”).

2.0  SCOPE:

       This SOP shall be applicable for Automatic Coating System (NEOCOTA 48”) in Coating Area in Production department.

3.0  RESPONSIBILITY:

3.1  Execution              : Operator
3.2  Checking               : Production Pharmacist & Above

4.0  ACCOUNTABILITY:

       HOD-Production / Assigned Designee

5.0  PROCEDURE:

5.1  Before starting coating process, check for the cleanliness of coating pan, pressure vessel, spray gun assembly and liquid hoses its part & area and ‘CLEANED’ label on it.
5.2  Before starting the operation production person get the line clearance from Q.A person by writing the status label with Product Name, Batch Details to equipment & area as per BMR.
5.3  Put the mains and the panel switches to ‘ON’ position.
5.4  Press the manual mode in micro processor screen then press bypass of PDM indicator.
5.5  Then Set the following matter in the micro processor screen as per requirement:
5.5.1  Batch Number by entering in data log.
5.5.2  Inlet temperature by entering in data log.
5.5.3  Outlet temperature by entering in data log.
5.5.4  Bed temperature by entering in data log.
5.5.5  Pan speed by entering in data log.
5.5.6  Printing cycle by entering in data log.
5.5.7  Spray “ON” and Spray “OFF” times as per requirement by entering in data log.
5.5.8  Set atomization air limit switch. This will set ‘OFF’ spray system if atomization air pressure falls below set air pressure manually.
5.6  Then Remove the lid of the liquid vessel and load the coating solution of required quantity. Close the lid of the liquid vessel. Activate the stirrer by Opening the compressed air supply knob.
5.7  Set the dosing percentage of the feed pump as per requirement by rotating the knob provided on the top of the pump.
5.8  Set the dosing RPM of peristaltic pump by rotating the knob right side, then Remove the spray gun assembly arm outside the pan and charge the core tablets into the pan.
5.9  Set the spray guns for liquid volume flow and spray pattern as follows:
5.9.1  Put ‘OFF’ the compressed air supply valve of zender filter (atomization air).
5.9.2  Press the selector switch on PDM bypass.
5.9.3  Press the selector switch on “Manual” Position.
5.9.4  Hold the measuring cylinder under each nozzle. Put ‘ON’ the spray switch (position) and measure the volume of coating solution collected in the cylinder after one minute cycle. Do the volume correction with the screw provided on the top of the gun.
5.9.5  Put “ON” the filter valve and the spray switch. Hold filter paper in front of the guns and check the spray pattern by observing it on the filter paper.
5.10  Start the coating process :
5.10.1  Start the pan, inlet damper & then start exhaust blower maintain the bed temperature as per BMR by press the heater “ON” position.
5.10.2  Press the hot air blower switch to start hot air blower.
5.10.3  Start the coating pan & adjust the distance between tablet bed & gun.
5.10.4  Introduce the spray gun assembly into the coating pan. Keep the guns to the tablet bed distance between 8-12cm for non-aqueous coating & for aqueous coating 7-10 cm. then Close and lock the front window.
5.10.5  Check the weight of 20 core tablet before loading & after drying & finally check the weight gain.
5.10.6  For Auto mode –press the auto mode.
5.10.7  Put “OFF” the heater switch.
5.10.8  Set the spray ON time & “OFF” time in micro processor screen as per requirement.
5.10.9  Set Pause timer as per requirement.
5.10.10  Press the `Auto cycle on’ switch and then `Film coating cycle on’ switch to start film coating.
5.10.11  Monitor inlet air temperature, outlet exhaust temperature throughout the coating process.
5.10.12  After completion of film coating allows the tablets to roll in the pan until the exhaust air temperature rises by 3 to 5°C for drying of the tablets.
5.11  Unload the tablets from the pan by using unloading device as follows:
5.11.1  Set the pan speed (R.P.M.) as per requirement.
5.11.2  Fix the scoop assembly on the pan mouth with the scoop is in between the two opposite baffles. Check proper fixing of the scoop assembly by pulling it outwards.
5.11.3  Fix the discharge hopper over the front window and unload the tablets by placing the drums containing polythene bags below the hopper.
5.12  Fill the “Equipment Log Book”.
5.13  After completion of operation. Put “OFF” the mains.
5.14  Affix “To be Cleaned” status label.

Related: Tablet Coating Problems and their Solutions in Pharmaceuticals

6.0  ABBREVIATIONS:

6.1  SOP: Standard Operating Procedure
6.2  BMR: Batch Manufacturing Record
6.3  Q.A.: Quality Assurance
6.4  HOD: Head of The Department
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question


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