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SOP for cleaning and sanitization of uncontrolled area.

  • Objective:
  • To lay down a procedure for cleaning and sanitization uncontrolled area.
  • Scope:
  • This SOP is applicable for cleaning and sanitization of uncontrolled area.
  • Responsibility:
  • Officers or above – Production.
  • Accountability:
  • Production Head.
  • Abbreviations
  • SOP : Standard Operating Procedure.
  • Ltr.: Liter
  • Procedure:
  • Uncontrolled area are primary packing material, Raw material store,(under test & approved), secondary packing material, packing Hall, documentation room, carton coding room, quarantine vials, finished good store etc.
  • Cleaning is done after completion of production work or whenever necessary with lint free duster soaked in purified water.
  • Clean the entire machine as per their respective standard operating procedure.
  • Collect rejected carton, release paper of roll label etc, from the floor with the help of mopper.
  • Clean the floor daily with mop soaked in purified water.
  • Disinfectant solution is used as per the sanitization schedule as per annexure-1.
  • Prepare 20 L of solution as follows with the help of measuring cylinder.
  • Concentration:
  • 1% Domex Solution = 19800 ml WFI + 200 ml Domex Concentrated
  • 1% Lysol    = 19800 ml WFI + 200 ml Lysol Concentrated
  • Sanitize the floors daily with super mop soaked in disinfectant solution.
  • Sanitize the Rooms as per the sequence decision in the attached format, one after     another.
  • Clean and sanitize walls, doors, window panels, switches and ceiling tube lights weekly, using super mop soaked in disinfectant solution.
  • Keep the equipment’s used for cleaning at specified place after washing and cleaning.
  • Fill the cleaning and sanitization record and get the cleaning checked by the concerned Supervisor/officer as per annexure-2.
  • Forms and Records (Annexures)
  • Sanitization schedule for uncontrolled area – Annexure – 1
  • Cleaning and sanitization of uncontrolled area – Annexure – 2
  • Distribution
  • Master copy –  Quality Assurance
  • Controlled copies- Quality Assurance, Production, Quality Control
  • History
    Date Revision Number
    Reason for Revision
    00 New SOP

Annexure – 1

Sanitization schedule for uncontrolled area  

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