SOP on cleaning of Paste Kettle in Pharma Industry
Standard Operating Procedure (SOP)
- Objective
- To lay down a procedure for cleaning of Paste Kettle in Pharma Industry.
- Scope
- This SOP is applicable for the cleaning of Paste Kettle in the formulation plant of Pharma Industry.
- Responsibility
- Production Operator/ Technician – For cleaning of the equipment.
- Production Officer/ Executive – For checking the cleanliness of the equipment.
- Accountability
- Production Head shall be accountable for compliance of SOP.
- Cleaning Procedure in Pharma Industry
- Cleaning during change over of Product/ Descending Potency (Type – A):
- Switch off main power supply of Paste Kettle.
- Remove “TO BE CLEANED” status label from the machine.
- Clean the outer of the kettle with dry lint-free duster.
- Clean the control panel and supporting legs of the kettle with dry lint-free duster.
- Clean the residue of previous product with dry lint-free duster.
- Wear the hand gloves and remove the paste adhered inside the kettle.
- Wash the paste kettle with purified water.
- Rinse the paste kettle with 10 L of purified water.
- Visually check the machine for cleanliness.
- Ensure that there is no residue of the previous batch on the machine.
- After cleaning activity, drop the lint-free duster in the dust bin.
- After completion of the cleaning, record the cleaning time of the machine in “Equipment Operation, Cleaning & Maintenance Log Book”.
- Affix “CLEANED” status label on machine.
- Intimate the IPQA Officer to collect swab/ rinse water sample for QC analysis.
- Cleaning during batch change over of same product (Type-B):
- Switch OFF main power supply of Paste Kettle.
- Removed “TO BE CLEANED” status label from the machine.
- Clean the residue of previous batch with dry lint free duster.
- Clean the control panel and supporting legs of the machine with lint free duster.
- Clean the outer and inner surface of the machine with clean lint free duster.
- Visually check the area for cleanliness.
- After cleaning activity, drop the lint free duster in the dust bin.
- After completion of the cleaning, record the cleaning time of the machine in “Equipment Operation, Cleaning & Maintenance Log Book”.
- Affix “CLEANED” status label on machine.
- Cleaning after preventive maintenance (Type – C):
- After completion of preventive maintenance clean the machine as per procedure mentioned below.
- Remove the “TO BE CLEANED” status label from the machine.
- Clean the outer and inner parts of the machine with lint-free dry duster.
- Clean the control panel and supporting legs of the kettle with lint-free duster.
- Clean the grease adhered to the machine with dry duster and use 70% IPA if required.
- After completion of the cleaning, record the cleaning time of the machine in “Equipment Operation, Cleaning & Maintenance Log Book”.
- Affix “CLEANED” status label on machine.
- List of Annexure / Format
- Not Applicable.
- References (if any)
- Instruction Manual.
- Reason for revision
- Not Applicable.
- Abbreviations
- SOP: Standard Operating Procedure
- No.: Number
- L: Liters
- QC: Quality Control
- IPQA: In-Process Quality Assurance
- QA : Quality Assurance
- QC : Quality Control
- IPA : Isopropyl alcohol
END OF SOP
