SOP on cleaning of Paste Kettle in Pharma Industry

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

AMPICILLIN DRY SYRUP