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SOP for Paste Preparation Vessel


Standard operating procedure of paste preparation vessel used for paste preparation to be used as binder in Granulation process.

1.0.  Purpose: 

To lay down the cleaning and operation procedure for Paste preparation Vessel.

2.0.  Scope: 

This procedure is applicable to Paste preparation vessel used for paste preparation to be used as binder in Granulation process.

3.0.  Reference  & Attachment:

3.1.  References:

3.1.1.  Instruction manual.

3.2.  Attachments:  

3.2.1.  Attachment- 1. Sequential Logsheet

4.0.  Responsibility:

4.1.  Operator:

4.1.1.  To clean the Paste preparation vessel as per defined procedure.
4.1.2.  To operate the Paste preparation vessel as per defined procedure.

4.2.  Production:

4.2.1.  To check cleaning and operation of the Paste preparation vessel as per defined procedure.
4.2.2.  To maintain equipment sequential log.

4.3.  Quality Assurance:

4.3.1.  To ensure the proper cleaning and operation of the Paste preparation vessel.
4.3.2.  To ensure the maintenance of records.

5.0.  Distribution:

5.1.  Manager Quality  (Master Copy)
5.2.  Manager Production
5.3.  Production Shop Floor (Display Copy)

6.0.  Definitions of terms:

6.1.  BMR: Batch Manufacturing Record

7.0.  Procedure:

7.1.  Cleaning procedure for product changeover

7.1.1.  Ensure that ‘To be Cleaned’ label is put on the equipment
7.1.2.  Ensure that the mains are switched ‘OFF ’.
7.1.3.  Ensure that steam valve is closed.
7.1.4.  Remove all adhered material from the vessel with the help of spatula.
7.1.5.  Loosen the bolt and dismantle the stirrer from the shaft.
7.1.6.  Wash vessel from inside, outside and stirrer with 30 ltrs. of running tap water followed by 1 ltr. of 2% nonionic detergent solution using nylon scrubber.
7.1.7.  Use 30 ltrs. hot water to remove any adhered material from the vessel.
7.1.8.  Finally rinse all with 40 ltrs. running purified water.
7.1.9.  Wipe external parts using dry duster.
7.1.10.  Visually ensure the cleanliness of the machine.
7.1.11.  Intimate QA dept. for line clearance.
7.1.12.  Dry all the parts using filtered compressed air.
7.1.13.  Assemble the Paste preparation vessel.
7.1.14.  Remove ‘To be Cleaned’ label and affix duly signed ‘Cleaned’ label on the equipment
Note: The cleaning of the equipment remains valid for 48 hours. If the equipment is not used within 48 hours then it should be recleaned as per above procedure starting from step 7.1.8.

7.2.  Cleaning procedure for batch to batch changeover:

7.2.1.  Ensure that the mains are switched `OFF’.
7.2.2.  Ensure that the Steam valve is closed.
7.2.3.  Remove all adhered material from the vessel with the help of spatula.
7.2.4.  Wash vessel from inside, outside and stirrer with 30 ltrs. running tap water.
7.2.5.  Finally rinse all with 30 liters running purified water.
7.2.6.  Wipe external parts using dry duster.
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 cleaning procedure for product changeover.

7.3.  Operating procedure:

7.3.1.  Checks and precautions:

7.3.2.  Wear hand gloves, over coat and nose mask during the operation.
7.3.3.  Ensure that incoming steam pressure is not less than 1.5 kg/sq cm.

7.3.4.  Procedure:

7.3.4.1.  Remove ‘Cleaned’ label and affix it in the BMR
7.3.4.2.  Affix ‘Under Process’ label on the equipment.
7.3.4.3.  Take purified water in the vessel as mentioned in the BMR.
7.3.4.4.  Prepare starch slurry using purified water as per BMR in another container.
7.3.4.5.  Drain the water in the return line if any. Close the trap.
7.3.4.6.  Put `ON’ the steam valve and stirrer motor.
7.3.4.7.  As soon as water starts boiling add the prepared starch slurry in it, so as to make translucent paste.
7.3.4.8.  Put `OFF’ the steam valve and stirrer motor.
7.3.4.9.  Bring the stirrer in parallel plane with the vessel.
7.3.4.10.  Rotate the side rotary knob in clockwise direction to tilt the vessel so as to unload the paste in the container placed below the discharge outlet.
7.3.4.11.  Remove any remaining material from the vessel using SS spatula.
7.3.4.12.  Rotate the side rotary knob in anticlockwise direction so as to bring the vessel in normal position.
7.3.4.13.  Remove ‘Under Process’ label.
7.3.4.14.  Affix ‘To be cleaned’ label on the equipment after completion of the operation.
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question


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