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Standard Operating Procedure (SOP) for Operation and Cleaning of Neocota Coating Machine 48’’ & 60’’ used in the coating process.

SOP for Neocota Coating Machine

1.0   Purpose:

• • The purpose of this SOP is to describe the procedure for efficient cleaning & operation of Neocota 48’’ & 60’’ in the coating process.

2.0   Scope:

• • This SOP is applicable for the cleaning & operation of Neocota 48’’ & 60’’ used in the coating process.

3.0   References & Annexures:

• • References:

• • Machine Manual

• • SOP for Cleaning of Newly Received SS parts, SS Fabricated parts.

• • Area & Equipment Usage Log.

• • Annexures: NA

4.0   Responsibilities:

• • User Department Head or Designee:

• • To operate as per SOP

• • To clean the equipment as per SOP

• • Quality Assurance:

• • To ensure cleaning of equipment as per the defined procedure.

• • Regulatory Affairs, Quality Head & Plant Head:

• • To review & approve the SOP.

5.0   Abbreviations – SOP for Neocota Coating Machine:

• • BMR: Batch Manufacturing Record

• • CC No.: Change Control Number

• • HMI: Human Machine Interface

• • IPA: Isopropyl Alcohol

• • NA: Not Applicable

• • NLT: Not Less Than

• • PLC: Programmable Logical Controller

• • RPM: Rotation Per Minute

• • SOP: Standard Operating Procedure

• • SS: Stainless Steel

• • WIP: Wash in Place

6.0   Procedure – Operation and Cleaning Neocota Coating Machine:

• • Checks & Precautions during Handling of Neocota Coating Machine:

• • Wear Acid/ Alkali Proof Hand Gloves & Nose Mask (Wear protective gear) while cleaning.

• • During commencing for cleaning ensure covering of HMI, wall mounted balance motor with transparent polybag.

• • Check the scrubber tank filled with water before starting of coating process (Neocota Coating Machine).

• • Check the main compressed air pressure is NLT 4.0Kg/Cm2 before starting the coating process.

• • The drain valve is closed before starting coating process.

• • During coating operator & helper must wear a nose mask, headgear, secondary gown& hand gloves.

• • Cleaning procedure of Neocota Coating Machine for Product Change Over:

• • Cleaning of Pan – Neocota Coating Machine:

• • Affix to be cleaned label on the equipment.

• • Keep the drain valve of the machine closed.

• • Cover HMI & pump housing with polybag.

• • Pour potable water in storage tank & run the peristaltic pump at 50RPM on running pan.

• • Scrub the inner side of the pan wall & baffles using nylon scrubber.

• • Use a long-handled nylon brush to remove adhered material deep inside of the pan & corner of baffles.

• • Take 10.0 liters of 2.0% Non-ionic solution & pour in storage tank & spray on the pan by running the peristaltic pump at 50.0RPM on running pan.

• • Use 15.0% Sodium Carbonate solution in the coating pan to remove the adhered materials.

• • Open the side doors of the pan, exhaust duct, inlet duct, & clean with potable water for 20 minutes followed by a rinse with potable water for 20 min.

• • Reassemble the side doors, exhaust duct & inlet duct after cleaning.

• • Then clean the pan by using purified water for 20 min.

• • Liquid Vessel & Spray Gun Cleaning of Neocota Coating Machine:

• • Take refractable arm outside of the pan cabinet.

• • In case of aqueous formulation & non-aqueous formulation use potable water & purified water except in case of enteric-coated product use 15.0% w/v of sodium carbonate solution.

• • Make entry in the utilization of the respective solvent whichever is used.

• • Then clean the liquid vessel & spray gun with 2.0litres of non-ionic solution & scrub all parts like an agitator, lid whole body with nylon scrubber & discard the solution.

• • Then clean liquid vessel & spray gun including all related parts with potable water for 5 min or till all adhered material removed, followed by a rinse with purified water for 2 min.

• • Each gun parts to be rinsed with purified water for 2.0 min.

• • Dismantle the spray gun & keep the parts of each gun in a separate polybag, clean the spray guns parts with 500ml non-ionic solution followed by washing with potable water & purified water for 2min.

• • Check the integrity of all ‘O’ ring of the gun needle, replace the defected ‘O’ ring with the new one.

• • Re-assemble all the gun parts after the complete cleaning process.

• • Disconnect the silicon tubes from storage tank or suspension tank & drain out the deposited water.

• • Dry the silicon tube with the help of compressed air.

• • Unloading Devices Cleaning – Neocota Coating Machine:

• • Wash the internal & external part of the unloading devices with running potable water for 5min.

• • Scrub the parts with nylon scrubber using 500ml of 2.0% Non-Ionic solution.

• • Rinse the above parts with potable water for 5min followed by a rinse with purified water for 5min.

• • Cleaning of Pump Housing & Outer Part of Spraying Housing:

• • Clean outer parts of peristaltic pump housing using wet duster followed by dry lint-free cloth.

• • Clean outer parts of the spraying unit using wet duster followed by dry lint-free cloth.

• • Cleaning & assembling of coating pan – Neocota Coating Machine:

• • If any other coating pans to be used for the next product then after cleaning the pan as per product to product changeover procedure mentioned above, the existing pan to be removed.

• • Existing pan to be removed after cleaning as per below procedure:-

• • Open front door & both side door of auto coater by unscrewing the bolt.

• • Remove the coating pan by pushing upward from the motor shaft.

• • Assemble the coating pan by pushing towards the motor shaft & set the shaft keys.

• • Set the exhaust duct, inlet duct joint piece as per dedicated pan size.

• • Sometime after the completion of coating, cleaning is difficult with only non-ionic solution, 15.0% sodium carbonate solution is used for cleaning purposes.

• • Cleaning Procedure for Batch to Batch Changeover – Neocota Coating Machine:

• • Ensure that ‘To be Cleaned’ label is put on the machine.

• • Keep PLC out of Auto or Manual mode by pressing RESET or LOGOUT key.

• • Ensure the pan & blower is switched off of the machine.

• • Remove adhered material from internal & external surfaces of the pan, gun housing& unloading devices (if used) using a dry lint-free cloth.

• • Clean the tank with a dry lint-free cloth.

• • Clean the silicone tubes using potable water or purified water& 2% non-ionic solution.

• • In case of enteric-coated products use a 15.0% sodium carbonate solution for cleaning purpose.

• • Remove the solid deposited in spray gun air cap by removing with the help of compressed air.

• • Dry the silicone tubes & spray gun parts using compressed air.

• • Check & replace the found defective ‘O’ ring with a new ‘O’ ring before proceeding for the next batch coating.

• • In case of formulation having acetone total ‘O’ ring set to be replaced with a new set.

• • Affix Partially Cleaned Label (Red Colored) on the auto coater & Storage tank.

• • Cleaning Procedure after Maintenance Work – Neocota Coating Machine:

• • In Case of contact parts of the machine got repaired then clean the machine as per product change over & in case of the contact part of the machine got welded then cleaning of the machine to be done as per SOP of cleaning of newly received SS parts, SS Fabricated parts.

• • For maintenance of non-contact parts, clean the machine to be free of oil, grease marks & ensure to cover the machine parts with a plastic sheet.

• • Labeling Procedure – Neocota Coating Machine:

• • Ensure that Cleaned Labels are put on the Neocota & liquid feed tank.

• • Remove Cleaned Card label & affix in the BMR.

• • Affix ‘Under Process’ label on the auto coater & storage tank.

• • Start-up Procedure of Neocota Coating Machine:

• • Put ‘ON’ the mains & HMI of the auto coater.

• • Load the coating suspension into the liquid feed vessel & close it properly.

• • Switch ON the electric supply to start mixing the operation of suspension in the vessel.

• • Load the tablets manually to the pan.

• • Check the integrity of all ‘O’ rings connected in each gun & if defect found in any of the ‘O’ rings to replace the same with the new one.

• • Validate the entire gun outside the pan before going for the coating process.

• • Take the refractable gun assembly within the pan & close the front door of the pan mouth properly.

• • Press LOGIN and enter the three-digit password and then press the next key (►) to go the main menu screen.

• • By pressing RESET key, Auto mode and Manual mode will be reset and then the required mode can be started.

• • By pressing RESET key, Auto mode and Manual mode will be reset and then the required mode can be started.

• • During the coating process, if the inlet air temperature is varying, then the CONDENSATE key can be pressed at any time and as per set time, it will OFF, automatically.

• • By pressing the EMERGENCY STOP button, immediately all the running process will stop & alarm sound will occur.

• • By pressing the EMERGENCY STOP button, immediately all the running processes will stop and the alarm will display. After releasing the emergency button and reset the alarm button, the process can be started.

• • Operating Procedure in Auto Mode – Neocota Coating Machine:

• • Keep PLC ON and pan light ON and wait for the Main screen.

• • Press the next key (►) to go to the main menu screen.

• • Then press the AUTO PARAMETERS key and set all required value in all process parameters as per requirement.

• • To go next screen, next key (►) to be pressed after entering all required value in Auto parameters.

• • Then press AUTO in the main menu screen, followed by press next key (►).

• • Press MAKE RECIPE to save auto parameter value in the recipe menu.

• • Press the PASSWORD key and then four-digit password and then press ESC.

• • Then press SAVE key to save the recipe.

• • Press the “Record number” key and enter the recipe name or code. Then press SAVE key.

• • Then press the RECALL key to select the required existing save recipe.

• • All recipes can be viewed by using up & down key and after selecting the required recipe; the display will run in local mode and come to the previous menu.

• • If the selected recipe is not to be transferred, then press the FREEZE key.

• • By pressing the TRANSFER key, all the parameter value of the selected recipe can be transferred to Auto mode parameters.

• • If the previously saved recipe is required, then in AUTO mode press the next key (►) and then press SELECT RECIPE and followed by pressing RECALL key to select the required existing save recipe.

• • By pressing the DELETE key, all recipe lists will appear on screen by pressing the next key (►).

• • Select the recipe by using up & down key and then press DELETE key & press, YES to delete the recipe. And then press the ESC key twice to get the previous menu screen.

• • Then press the previous key (◄) to go to the main menu screen.

• • Then enter batch code & lot no. and press the next key (►) to go FILM coating menu screen.

• • To start the process, press the START key and the process will start as per the logical sequence.

• • Process parameters can be changed by pressing the PROCESS DATA key and subsequently press PARAMETERS key.

• • During the coating process, the process can be stopped temporarily by pressing the PAUSE PROCESS key and can be continued by pressing the CONTINUE PROCESS key.

• • During the coating process, dosing can be stopped by pressing the PAUSE DOSING key and can be restart by pressing the START DOSING key.

• • If dosing stopped more than 1 minute, then the pan will be stopped.

• • At any stage, if the END PROCESS key pressed, then the coating process will stop and skip to the next FILM cycle or JOG cycle menu.

• • Operating Procedure of Neocota Coating Machine in Manual Mode:

• • Keep PLC on and pan light ON and wait for the Main screen.

• • Press the next key (►) to go to the main menu screen.

• • Then press the MANUAL key and followed by pressing MANUAL PARAMETERS.

• • Set all required value in all process parameters as per requirement.

• • To go next screen, next key (►) to be pressed after entering all required value in MANUAL PARAMETERS.

• • Then press SELECT MANUAL MODE on the menu screen.

• • The coating process can be started by pressing the keys in a logical sequence as per requirement.

• • The coating parameter can be changed during the coating process by changing the set value in a manual screen or by changing the set value in the PROCESS DATA key.

• • Operating Procedure of Retractable Arm of Neocota Coating Machine:

• • On pressing RETRACTABLE ARM IN or OUT alarm will be displayed for the front door opened and pressing appropriate key YES or NO, the retractable arm will be IN or OUT.

• • Operating Procedure of Gun Validation of Neocota Coating Machine:

• • Press the MANUAL key and followed by then press SELECT MANUAL MODE in the menu screen.

• • Press PROCESS DATA and then press the GUN VALIDATION key.

• • Gun validation to be performed before starting the coating process, to find out the spray rate in gm or ml per gun per minute.

• • Set all required value in all parameters as per requirement.

• • During checking of gun validation, atomization air & fan air should be stopped and set value for the above air should be “0” in the PROCESS DATA menu.

• • Press GUN VALIDATION key, to start the spraying process and collect the solution in the appropriate container & weigh-in calibrated balance to check the spray volume got in 1 minute in particular peristaltic pump RPM.

• • Procedure after Completion of Coating – Neocota Coating Machine:

• • After the coating process, if any unusual observation is there, immediately take the corrective action by consulting with production officer/quality assurance.

• • Run the coating until the complete coating solution is exhausted or desired weight gain achieved.

• • Dry the coated tablets at bed temperature for 15 to 20 minutes in case of film-coated product.

• • After complete drying of the coated tablets cools down the tablets by closing the inlet valve at least pan rpm.

• • After ensuring proper cleaning, unload the coated tablets by unloading the device or manually in the suitable cleaned containers lined with a double polyethylene bag and properly labeled.

• • Affix ‘To be cleaned’ label in case the batch is completed on the Neocota and the liquid feed tank.

• • At the end of the day’s coating activity, if the coating is not completed, then disconnect the silicon tubes(at suspension storage tank), dip in the vessel having 2.0 liters of purified water&run the water through the silicon tubes and gun outside the pan in a polybag. Drain the water after cleaning of silicon tube & gun.