sop on operation and cleaning of coating pan


sop on operation and cleaning of coating pan



1.0 Objective: To describe the procedure for operation and cleaning of coating pan.
2.0 Scope: This procedure is applicable to coating pan
3.0 Responsibility: Operator / Production Officer / Executive
4.0 Accountability: Department Head shall be accountable for the compliance of the system.
5.0 Procedure:

5.1 Operation:
5.1.1 Check the cleanliness of the machine as well as the area. There should not be any remainants of the previous product.
5.1.2 Switch “ON” power supply.
5.1.3 Load the tablets in to the pan as specified in batch manufacturing record.
5.1.4 Set the coating parameters such as inlet temperature, outlet temperature, pan speed, air pressure, and spray rate, as specified in batch manufacturing record.
5.1.5 Insert the spray guns assembly in to the pan and start automizing air by turning the knob left side then start the peristaltic pump.
5.1.6 Adjust the spray rate as required.
5.1.7 Clean the spray guns intermittently with brush.
5.1.8 After completion of the solution or process dry the tablets for at least 5 to 10 minutes.
5.1.9 Close the operation, affix the unloading assembly.
5.1.10 Unload the tablets in double polylined HDPE containers with labels.
5.1.11 Affix “TO BE CLEANED” label on the equipment.
5.2 Cleaning: [For Product Change]
5.2.1 Dismantle the spray guns, silicon tubes from the gun stand and send it to washing area.
5.2.2 Rotate the pan and wash it with purified water till the residues of the previous product there.
5.2.3 Drain the water from the pan.
5.2.4 Swipe the parts of the pan with a clean dry lint free cloth.
5.2.5 Clean the out side of the machine wet cloth followed by clean dry lint free cloth.
5.2.6 Clean the electric parts of the machine with dry clean cloth.
5.2.7 Wash the gun, assembly and silicon tubes with purified water and dry it with lint free cloth.
5.2.8 Affix a “CLEANED” label on it.
5.2.9 Record the same in logbook.
5.3 Cleaning: [For Batch Change]
5.3.1 Ensure that power supply to the machine is disconnected.
5.3.2 Ensure that there should not be any tablets inside the pan.
5.3.3 Clean the machine with lint free clean lint free cloth.
5.3.4 Affix the “CLEANED” label on it.
5.3.5 Record the activity in log book.
5.4 Cleaning: (At the End of the Shift)
5.4.1 Clean the machine parts with the clean lint free cloth.


6.0 Abbreviations:

Abbreviation Expanded Form
SOP Standard Operating Procedure
PR Production
QA Quality Assurance
HDPE High Density Poly Ethylene

7.0 Forms and Attachments:
Annexure – 1: Equipment Log Book

8.0 Distribution List:

S. No. Department Name No. of Copy
1. Quality Assurance 01
2. Production 01


9.0 References:
In – House

Annexure – 1

Equipment Usage Log Book

S. No. Date Product Name B. No. B. Size Operation Time Cleaning


Done By Ckd. By Brk. Down Time Done By Remarks

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