SOP for operation of Auto coater
Standard Operating Procedure (SOP)
1.1 To lay down a procedure for operation of Auto coater.
2.1 This SOP is applicable for operation of Auto coater in the formulation plant.
- Production Operator/ Technician – For operation of the machine.
- Production Officer/Executive -To maintain proper functioning of the equipment & procedure.
- Head of Production shall be responsible for the compliance of SOP.
- Pre-start up:
- Visually check the cleanliness of the room/ equipment and ensure that the area/ equipment are free from remains of previous product/ Batch.
- Remove the “CLEANED” label from the machine.
- Fix the “EQUIPMENT STATUS” label on machine.
- Check the room temperature and relative humidity and record the observation as per SOP No. QA-SG-004. If environmental conditions are not found within the limit, inform the maintenance department for rectification and don’t proceed further, till it gets rectified.
- Switch “ON” the mains of machine.
- Check for water level in scrubber, if water level is found satisfactory, process further or else fill / change the water.
- Check for compressed air supply. It shall not be less than 4 Kg/cm².
- Fill the coating solution in the holding tank and set the gun validation.
- Equipment Details:
- Name of the equipment : Ganscoater
- Manufactured By : Gansons Limited.
- Equipment Specification:
|POGAC–01||40-70 Kg (36” Pan)
70-150 Kg (48” Pan)
- Machine Major parts and it`s functions
|Sr. No.||Name of the machine part||Function|
|01||Coating Pan||To load the tablets for coating.|
|02||Baffles||To provide the movement to the tablets during coating|
|03||Spraying assembly||To spray the coating solution on the tablets.|
|04||Control Panel||To control and the various functions of the machine.|
- Switch on the main power supply of the machine.
- Ensure that line clearance has been taken to start the batch.
- Transfer the uncoated tablets to the coating area.
- Divide the batch in different lots if required.
- Ensure the cleanliness of coating pan which is to be used for coating and ensure that swab for coating pan is passed.
- Open the acrylic window and charge the uncoated tablets in the coating pan as mentioned in BMR.
- Control panel of the machine is as follows
- Click on the “SELECT MENU” from the screen.
5.4.9 Click on the “PASSWORD” from the below screen.
5.4.10 Click on the “LOG IN” from the below screen and enter the password.
5.4.11 Click on the “SET PARAMETERS” from the below screen
5.4.12 Set the inlet air temperature, Exhaust air temperature, from below screen as
mentioned in BMR. Click on the “MAIN MENU” to get the home screen.
5.4.13 Click on the “CONTROL PANEL” from the below screen
5.4.14 Select the machine mode to “AUTO” and Click on the next button (>).
5.4.15 Start the EXHAUST BLOWER, by clicking on “START” button
5.4.16 Start the INLET BLOWER by clicking on “START” button.
5.4.17 Start the PAN MOTOR by clicking on “START” button as per requirement.
5.4.18 Start the DOSING PUMP by clicking on “START” button after pre-heating of tablets.
5.1.19 Pre-warm the tablets at set temperature as mentioned in BMR.
5.1.20 Take the 20 tablets after pre-warming and record the weight in BMR.
5.1.21 Start the spray of coating solution as mentioned in BMR
5.4.22 Click on the “MAIN” from above screen to get the home screen.
5.4.23 Start the coating pan and check the RPM, inlet temperature, exhaust temperature as specified in BMR.
5.4.24 After completion of the coating, allow the tablets to dry for specified time and pan RPM as mentioned in BMR.
5.4.25 Allow the tablets to cool to room temperature.
5.4.26 Unload the tablets from coating pan into the polythene lined HDPE containers.
5.4.27 Check the weight of each container and record details on label and BMR, transfer coated tablets containers to Tablet Quarantine area.
5.4.28 Record the operation in the log book in “Equipment Operation, cleaning & Maintenance Log Book” as per SOP No. QA-SG-037.
5.4.29 Remove the “EQUIPMENT STATUS” label and affix “TO BE CLEANED” label to the coating pan, solution container etc.
- Procedure for cleaning of Wet Scrubber
- The cleaning hours of scrubber shall be done twice in a month (15 days ± 3 days).
- Clean the outer surface of the scrubber with dry duster and remove the dust from outer surface.
- Remove the filter of scrubber and clean it with water and allow the filter to dry.
- Drain the water from scrubber by opening the drain valve.
- Open the lid of the scrubber.
- Remove the powder/dust particles manually and collect in HDPE container.
- Add the 2% NaOH solution in the container and stir it manually through rod.
- Clean the inner side of scrubber through wiper to remove the adhered particles.
- Fill the fresh water in the scrubber twice or as per requirement and drain it to clean the scrubber.
- Assemble the dried filter at its appropriate place.
- Destroy the solution contained in HDPE containers in ETP.
- Record the cleaning in the format (Annexure POSP013/A01).
6.0 List of Annexure / Format
|Sr. No.||Format Title||Format number||Annexure No.|
|01||Water level / Cleaning of Scrubber||POSP013/F01-03||POSP013/A01|
7.0 References (if any)
7.1 Instruction Manual
8.0 Reason for revision
8.1 Periodic Revision
9.1 SOP : Standard Operating Procedure
9.2 No. : Number
9.3 HDPE : High Density Poly Ethylene
9.4 BMR : Batch Manufacturing Record
9.5 °C : Degree Celsius
9.6 i.e. : That is
9.7 RPM : Revolution per Minute
END OF SOP
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube