sop for operation and cleaning of coating machine

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sop for operation and cleaning of coating machine

Purpose
1.1 To lay down a procedure for Operation and Cleaning of Coating machine.
2.0 Scope
2.1 This SOP is applicable for Operation and Cleaning of Coating machine in ABC Pvt. Ltd.
3.0 Responsibility
3.1 Machine Operator To execute the procedure.
Production & QA officer Follow the procedure as per SOP
Head Production Training and Implementation of SOP

4.0 Accountability
4.1 Production Head is accountable for compliance of this SOP.
5.0 Procedure
5.1 Pre-Startup
5.1.1 Check the cleanliness of the Area.
5.1.2 Check the material lying in the room is of the same batch to proceed.
5.1.3 Update the status label with details.
5.1.4 Take the line clearance from QA.
5.1.5 Check the cleanliness of the room / equipment and ensure that the area / equipment is free from any remnants of the previous product.
5.2 Operation
5.2.1 Load required quantity of uncoated tablets in to the coating pan.
5.2.2 Arrange the position of the hot air blower, switch on the hot air blower and allow the tablet bed to heat up.
5.2.3 Adjusted the air pressure as instructed in BMR.
5.2.4 Adjusting the spray of solution by-
• Pattern of spray.
• Spray width.
• Distance of the gun from the tablet bed.
• Atomizing air pressure.
5.2.5 Press the green button at the panel to run the Coating Pan.
5.2.6 Pour/Spray the coating solution on the rolling tablets in Coating Pan and do the coating.
5.2.7 Operate the coating pan till a smooth layer is formed and the tablets gain weight as stated in BMR.
5.2.8 Check the In-process of tablets as per specified in BMR.
5.2.9 Once the tablet coating confirms, transfer the coated tablet in to double-layered poly bags

and keep in a tightly closed container till the packing commences.
5.2.10 Switch off hot air blower, coating pan, exhaust system, hot air blower pipes and exhaust pipes.
5.2.11 Affix the status label indicating “To be cleaned” on the Coating Pan.
5.2.12 Record the activity in the Equipment Log book.
5.3 Cleaning
5.3.1 Type A (Product to product changeover)
5.3.1.1 Switch “OFF” the machine and main power supply.
5.3.1.2 Dismantle the silicon tube, blower pipe, exhaust pipe, spray gun from the gun stands and

send it to the washing area.
5.3.1.3 Transfer the Stirrer, SS Bowl, SS Vessel, scrapper to the washing area.
5.3.1.4 Wash and scrub the Coating Pan with raw water and scrubber to remove residues of the previous product.
5.3.1.5 Inspect the pan visually for color presence. If required repeat the steps.
5.3.1.6 Rinse the Coating Pan with purified water.
5.3.1.7 Clean the external surface of the Coating Pan with moist (moist in purified water) lint free clean cloth.
5.3.1.8 Wash Stirrer, SS bowl, SS vessel, SS scrapper using Raw water and scrub with nylon scrubber and nylon brush.
5.3.1.9 Rinse Stirrer, SS bowl, SS vessel, SS scrapper with purified water and transfer back to the coating pan.
5.3.1.10 Clean the electric panel of the machine with dry clean lint frees cloth.
5.3.1.11 Wash the blower pipe and exhaust pipe with Raw water, nylon scrubber and nylon brush.
5.3.1.12 Rinse the blower pipe and exhaust pipe with purified water.
5.3.1.13 Wash the spray gun, and silicon tube with raw water.
5.3.1.14 Rinse the spray gun and silicon tube with purified water and transfer back to the coating pan.
5.3.1.15 Dry the Coating Pan with dry lint free cloth.
5.3.1.16 Dry the stirrer, SS bowl, SS vessel, SS scrapper using dry lint free cloth.
5.3.1.17 Record the cleaning activity in the Equipment Log book.

5.3.2 Type B: Batch to batch changeover
5.3.2.1 Update the status board of the area as “UNDER CLEANING”.
5.3.2.2 Switch ‘OFF’ the main supply.
5.3.2.3 Clean the internal & external surface of the Coating Pan, blower and spray gun using

dry lint free clean cloth to remove the powder and remove the previous status label.
5.4 Training shall be provided to the concerned person.

6.0 References:
In-house

7.0 Attachment
Nil

8.0 Distribution:
8.1 Distribution of the controlled copy of the SOP shall be made by concerned departments.
8.2 Additional copies may be issued for specific purpose.

9.0 Abbreviations:
SOP : Standard Operating Procedure
Pvt. : Private
Ltd. : Limited
QA. : Quality Assurance
QC : Quality Control
SS : Stainless steel
10.0 Revision History