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Standard Operating Procedure for Operation and Cleaning of Auto Coater – Automatic Coating Machine used for Tablet Coating during manufacturing of pharmaceutical solid dosages form.

Auto Coater – Automatic Coating Machine

1.0   Objective :

• • To lay down the procedure for cleaning and operation of Auto Coater- Automatic Coating Machine.       

2.0   Scope :

• • This SOP is applicable in Tablet Manufacturing Area  for different types of coating through Auto Coater- Automatic Coating Machine.

3.0   Responsibility :

• • Production Operator : To follow the Operation and cleaning procedure.

• • QA : To Check and verify the operation and cleaning procedure.

4.0   Procedure for Cleaning of Auto Coater- Automatic Coating Machine :

• • Product change over (Type A) – Auto Coater :

• • Affix the (To be clean status label) in area and equipment.

• • After enteric coated activity 20% NaOH solution shall be used for cleaning purpose.

• • Fill the vessel with potable water and start the pneumatic stirrer.

• • Open the outlet valve of the S.S. vessel.

• • Remove the nozzle caps of the spray gun of Auto Coater.

• • Place 50 kg capacity polybag to collect the water from the spray gun.

• • Press the spray key to allow the water to pass through the flexible hose and spray gun.

• • Repeat the process twice and drain the water.

• • Stop the pneumatic stirrer by closing the compressed air valve.

• • Scrub the S.S. vessel with the help of nylon brush.

• • Wash with sufficient potable water.

• • Rinse the S.S vessel with sufficient purified water.

• • Dry the S.S. vessel with a dry lint free cloth.

• • Fill the vessel with 1 liter Isopropyl Alcohol.

• • Press the spray key to allow the Isopropyl Alcohol to pass through the flexible hose and spray gun of Auto Coater.

• • Cover the control panel with a polybag.

• • Open the side covers of the inlet and exhaust ducts.

• • Connect the Inlet valve of the potable water to the cleaning bar.

• • Open the drain valve of the Machine.

• • Remove the exhaust hood from the pan by loosing the clamps of Auto Coater..

• • Switch “ON” the supply by releasing the red button (Emergency button) provided on the panel.

• • Press “LOG IN” and enter the User name and password.

• • Press the green switch to put “ON” the control panel

• • Select the disable button to start the WIP system.

• • Press start button to run the rinsing cycle of Auto Coater..

• • Ensure the “RPM” of the pan is kept between 2-5.

• • After 15 minutes, stop the WIP system and switch ON the WIP drain to release water.

• • Clean the Pan with potable water and a soft nylon scrubber.

• • Rinse the Pan with sufficient purified water.

• • Clean the exhaust hood with sufficient potable water.

• • Rinse with sufficient purified water.

• • Clean the outer surface and top surface using a wet lint free cloth and dry it with a dry lint free cloth.

• • Check the cleanliness of the Auto Coater pan visually.

• • Fix the exhaust hood with the help of clamps.

• • Intimate to QA to take the swab sample and send it to QC along with duly filled & signed Swab Test Intimation Slip / Analysis Report.

• • After analysis QC chemist shall enter the details in “Swab Test Intimation Slip / Analysis Report” and send back to production.

• • If the report is OK then put the status label cleaned.

• • If the report is not OK then repeat the above procedure.

• • Close the side covers of the Inlet and exhaust ducts by locking the 2 clamps.

• • Put “ON” the blower in the manual mode of Auto Coater, and dry the pan at 80°C for 15 minutes.

• • Disconnect the inlet of potable water supply to the machine.

• • Close the drain valve of Auto Coater..

• • Clean the area.

• • Enter the details in the Equipment log.

• • Validity: 72 Hours.

• • After validity period before start next process, clean the equipment.

• • Batch change over (Type B) -Auto Coater:

• • Change the status of area & equipment.

• • Fill the vessel with potable water and start the pneumatic stirrer.

• • Open the outlet valve of the stainless steel vessel.

• • Remove the nozzle caps of the spray gun.

• • Place 50kg capacity polybag to collect the water from the spray gun.

• • Press the spray key to allow the water to pass through the flexible hose and spray gun.

• • Repeat the process twice and drain the water.

• • Stop the pneumatic stirrer by closing the compressed air valve.

• • Rinse the S.S vessel with potable water followed by purified water.

• • Dry the S.S. vessel with a dry lint free cloth.

• • Clean the inside & outside surface of the machine with a dry lint free cloth.

• • If the processing of next batch takes more than 48 hours then clean the equipment following point (Type A cleaning).

• • Enter the details in Equipment Log.

• Operation of Auto Coater.

• • Ensure that the Auto Coater is clean and status label is affixed on the Auto Coater.

• • Make sure the proper working of HVAC system by checking the pressure difference of area & temperature and RH.

• • Ensure that the workmen are properly gowned using snood and hand gloves.

• • Get the line clearance from QA chemist before starting the operation.

• • Start the process as per instruction given in BMR.

• • Switch ON the supply by releasing red button (Emergency button) provided on panel.

• • Press Log in and enter User Name and password.

• • Main Screen shall be displayed.

• • Click on the above Screen to log in.

• • Enter User and Password Details.

• • Overview Screen shall be displayed. Auto mode and Manual mode Shall be displayed.

• • Select AUTO MODE in overview Screen.

• • Select other option for arm seal and door seal.

• • Then select Parameter and enter the details.

• • Parameter screen shall be displayed, enter Batch details and select NEXT to go to General Parameters.

• • Enter General Parameter Details and select NEXT to go to Pre Jog Parameters Screen

• • Provide details in General Parameters and Pre Jog Parameters and select NEXT to go to Doshing Screen

• • Enter details in Doshing and select NEXT To go to Post Jog Parameters.

• • Enter details of Post Jog Parameters and select NEXT

• • Select main screen and enter Start to run the coating process.

• • Select MANUAL MODE from Overview Screen.

• • Manual mode screen shall be displayed, enter other option for arm seal and door seal.

• • For arm seal and door seal. Select Arm seal and door seal and enter main screen of Manual Mode

• • Select Parameters from Manual Screen and enter User and Password.

• • Parameter screen shall be displayed, Enter details in Temperature Parameters and select NEXT

• • Enter Details in parameters and select NEXT.

• • Enter Details in Parameters and select NEXT

• • Manual mode screen shall be displayed

• • Finally click on various screen icon for adjusting settings to run the coating machine in manual mode.

• • Enter the details in BMR and in Equipment Log Sheet.

5.0   Annexure of Auto Coater :

Annexure-I: Cleaning check list of Auto Coater. 

Previous Product Name…………………….                 Batch No……………………..

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