SOP for Cleaning of Paste Kettle

Standard operating procedure to clean the Paste Kettle.

1.0 OBJECTIVE:

To lay down the cleaning procedure for Paste Kettle.

2.0 SCOPE:

This SCP shall be applicable for Paste Kettle used in Granulation area at Production department.

3.0 RESPONSIBILITY:

3.1 Execution :Operator
3.2 Checking :Pharmacist and Above

4.0 ACCOUNTABILITY:

HOD-Production

5.0 PROCEDURE:

5.1 Fill the vessel with 75 liter Potable water and start steam. Boil the water in the vessel till any material adhered in the vessel is removed.
5.2 Drain out the boiled water, Scrub if necessary.
5.3 Wash with “Teepol” solution and rinse with 25 liter Potable water till all the residue is washed off.
5.4 Finally rinse with about 25 liter purified water.
5.5 Wipe out with clean dry lint free cloth.
5.6 Finally wipe with 70 % v/v solution of Isopropyl Alcohol (IPA).
5.7 Affix the “Cleaned” label and fill the “Equipment Log Book” (Annexure-I).
5.8 Re-clean if not used within 72 hours.

6.0 ABBREVIATIONS:

SCP :Standard Cleaning Procedure
IPA :Isopropyl Alcohol
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is a prominent Pharmaceutical Quality Assurance expert, consultant and the founder of Pharmaguideline. With over 22 years of hands-on experience in cGMP-compliant manufacturing environments, he specializes in establishing validation protocols, sterile area controls and data integrity systems. Ankur routinely interprets international regulatory frameworks (including FDA, EMA and ICH guidelines) to help global pharmaceutical professionals ensure strict regulatory compliance and operational excellence. Connect with Ankur on LinkedIn. Need Help: Ask Question

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