Auto Coater – Operation & Cleaning Procedure

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.Auto Coater - Tablet Coating Machine
    • 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……………………..

Sr. No Check Points

1.0

Dismantling:  
 
  • Dismantle the tablets unloading assembly.
  • Open the materials charging window and take the gun bar of coater.
  • Dismantle all the Guns from the gun assembly.
  • The exhaust duct dismantle, Inlet and outlet Duct.
  • Dismantle the solution spraying pipes system.
 

2.0

Cleaning:  
 
  • Allow to pass the one liter Isopropyl Alcohol to pass through the flexible hose and spray gun.
  • Clean the inner surface of the coating machine with the help of process water by using WIP system.
  • Clean the outer surface of the coating machine with process water.
  • Rinse the Pan with sufficient purified water.
  • Clean the exhaust hood with sufficient potable water.
  • Rinse with sufficient purified water.
  • Dry the pan at 80°C for 15 minutes.
  • Dry the external surface with dry lint free cloth / by using compressed air.
 

3.0

Visual Inspection or checkpoints:  
  Part Name Cleaning status  

 

 

 

 

 

 

 

 

 

Materials charging window Cleaned / Not Cleaned
Coating pan Cleaned / Not Cleaned
Baffles Cleaned / Not Cleaned
Exhaust Duct, Inlet and Outlet Duct Cleaned / Not Cleaned
Silicon tube Cleaned / Not Cleaned
Gun assembly Cleaned / Not Cleaned
Bed Sensor Cleaned / Not Cleaned
Intactness of gaskets Cleaned / Not Cleaned /NA
Loosen nut /bolt Yes / No/ NA

4.0

Reassembly:  
 
  • Reassemble the guns to gun bar assembly.
  • Assemble  exhaust duct
  • The gun bar assembled to pan.
  • Assemble the solution transfer pipes.
 

5.0

Cleaning of surrounding area:  
 
Checked by :Production chemist
Verified By : QA / Remarks if any :-

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Janki Singh

Mrs. Janki Singh is the professional pharmaceuticals Blogger. She has already posted more than #1000 articles on varrious topics at different blogging plateforms. Contact : guideline.sop@gmail.com