CTL Pharmaceuticals Pvt. Ltd.

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Standard Operating Procedure
SOP No.:
SOP/PRD/05-01
Title: Operation and cleaning of Paste Kettle Supersedes:

Prepared By Checked By Authorized By Effective Date:

…………
Review Date:
QA Officer Production In-Charge Factory Manager
Date: Date: Date: ………….

1. PURPOSE:
1.1. The purpose of this SOP is:
1.1.1. To establish a correct process of operating the paste kettle so that the machine
performs correctly.
1.1.2. To minimize the accident and breakdown of the machine
1.1.3. To establish a standard practice to clean the equipment so contamination of the
product by previous product is controlled.
2. SCOPE:
2.1. The procedure is applicable for:
2.1.1. The operation of the paste kettle for wet granulation of tablets
2.1.2. Cleaning of paste kettle
3. RESPONSIBILITIES:
3.1. It is the responsibility of Quality Assurance (QA) Department for issue and update the
SOP in consultation with Production in charge.
3.2. It is the responsibility of trained operator for the operation of Paste Kettle as per this SOP.
3.3. Production in-charge shall be responsible for implementation of this SOP.
4. SCHEDULE:
4.1. As & when applicable
5. PROCEDURE:
5.1. Operation of Paste Kettle:
5.1.1. Production person shall ensure the cleanliness of the Paste Kettle, its part and area
and ‘CLEANED’ label on it.
5.1.2. Before starting the operation production person get the line clearance from
authorized person and affix the status label with Product Name, batch details to
equipment and area"
5.1.3. Put "ON" the mains, set the temperature.
 CTL Pharmaceuticals Pvt. Ltd.
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Standard Operating Procedure
SOP No.:
SOP/PRD/05-01
Title: Operation and cleaning of Paste Kettle Supersedes:

Prepared By Checked By Authorized By Effective Date:

…………
Review Date:
QA Officer Production In-Charge Factory Manager
Date: Date: Date: ………….

5.1.4. Load the measured quantity of Purified Water as per Batch Manufacturing Record.
5.1.5. Add the dispensed materials in vessel and run propeller to stir till the desired paste
obtained and put off the temperature.
5.1.6. Tilt the vessel very slowly for unloading the charged materials with the help of the
sidewheel by moving anticlockwise direction.
5.1.7. After unloading the contents, tilt back the vessel in its original position by moving
side wheel clockwise.
5.1.8. Put “OFF” the mains after completion of operation,
5.1.9. Affix " To be cleaned " label and fill the " Equipment/Machine Log book"
5.2. Precaution:
5.2.1. Do not touch the electrical components with wet hands. Ensure that the electrical
supply is cut off during cleaning.
5.2.2. Be careful not to exceed the temperature of the water and paste. 6.1.3" Wear proper
nose mask and eye goggles.
5.2.3. Ensure that the proper earthing has been done.
5.2.4. Use hand gloves while loading and unloading of material in kettle.
5.2.5. Handle cleaning agent and disinfectant with care; never take your hands towards
your mouth and eyes during such activities.
5.2.6. Always wash your hands with soap after handling these agents.
5.2.7. Lint producing material such as rugs, towels must not be used to dry the equipment.
5.3. Cleaning Procedure:
5.3.1. Fill the vessel with 50 liter of potable water and start boiling. Boil the water in the
vessel till any material adhered in the vessel is removed.
5.3.2. Drain out the boiled water, scrub if necessary.
5.3.3. Wash with 20 ml of liquid soap or use Jet cleaner and rinse with Potable water till
all the residue is washed off.
 CTL Pharmaceuticals Pvt. Ltd.
Page 3 of 3
Standard Operating Procedure
SOP No.:
SOP/PRD/05-01
Title: Operation and cleaning of Paste Kettle Supersedes:

Prepared By Checked By Authorized By Effective Date:

…………
Review Date:
QA Officer Production In-Charge Factory Manager
Date: Date: Date: ………….

5.3.4. Wipe out with clean dry lint free cloth.

5.3.5. Finally wipe with 70 % v/v solution of Isopropyl alcohol.
5.3.6. Affix "Cleaned " label and fill the " Equipment/ Machine Log book

6. LIST OF ATTACHMENTS / FORMATS:

6.1. NA
7. RELATED DOCUMENTS:
7.1. NA

8. ABBREVIATION:
QA : Quality Assurance
SOP: Standard Operating Procedure
V/V: Volume/Volume

END OF DOCUMENT