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