SOP for Operation and Cleaning of Paste Preparation Vessel

OBJECTIVE

To provide a procedure for the operation and cleaning of the Paste preparation vessel.

SCOPE

It is applicable to the operation and cleaning of the Paste preparation vessel located in the Granulation area of the Production department.

• Steam heating vessel.
• Oil heating vessel

RESPONSIBILITY

Operator: To operate and clean the equipment as per this procedure.

Supervisor: To ensure that the SOP is followed.

PROCEDURE

Operation

• Checks and Precautions:

1. Wear hand gloves, an overcoat, and a nose mask during the operation.
2. Ensure that there is a sufficient level of heating oil in the jacket of the vessel.

• Ensure the cleanliness of the Paste preparation vessel and the area.
• Ensure that the mains are switched ‘ON’.
• Ensure line clearance from QA before initiating the work.
• Add Purified water in the vessel as mentioned in the BMR and allow it to heat until it starts boiling.
• In a separate SS container prepare the slurry which is to be added to the boiling water as stipulated in the respective BMR.
• Add the above slurry to the boiling water in the vessel and stir it using an external SS stirrer/rod till the translucent paste is formed.

• Switch ‘OFF’ the mains.
• Transfer the contents of the Paste preparation vessel in another SS container. Use SS scraper/spatula to remove materials adhered to the inner surfaces of the vessel.
• Record the details of the operation in the respective BMR.

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Cleaning

For Batch Change-over:

• Switch off the main power supply.
• Remove all the adhered materials from the vessel with the help of SS scraper/spatula.
• Wash the paste preparation vessel from inside, and outside and the SS stirrer/rod with the help of running raw water.
• Finally, rinse with Purified water.
• Wipe the external parts using a dry cloth/duster.

For Product Change-over:

• Switch off the main power supply.
• Remove all the adhered materials from the vessel with the help of SS scraper/spatula.
• Wash the paste preparation vessel from inside, and outside and the SS stirrer/rod with the help of running raw water, using 2% of non-ionic surfactant solution if required.
• Use hot raw water to remove any materials still adhering to the vessel.
• Finally, rinse with Purified water.
• Wipe the external parts using a dry cloth/duster.
• Visually ensure the cleanliness of the machine.

Note: The cleaning of the equipment remains valid for 48 hours. If the equipment is not used within 48 hours then it should be re-cleaned as per the cleaning procedure mentioned for Product change-over.

ABBREVIATIONS

SOP: Standard Operating Procedure.

BMR: Batch Manufacturing Record.

SS: Stainless Steel.

REVISION HISTORY

Nil

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