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SOP on cleaning of Paste Kettle

SOP on cleaning of Paste Kettle

Standard Operating Procedure (SOP)

  • Objective
    • To lay down a procedure for cleaning of Paste Kettle.
  • Scope
    • This SOP is applicable for the cleaning of Paste Kettle in the formulation plant.
  • 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
  • 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

About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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