- To lay down a procedure for cleaning and sanitization uncontrolled area.
- This SOP is applicable for cleaning and sanitization of uncontrolled area.
- Officers or above – Production.
- Production Head.
- SOP : Standard Operating Procedure.
- Ltr.: Liter
- 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.
- 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
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production, Quality Control
Date Revision Number
Reason for Revision
– 00 New SOP
Annexure – 1
Sanitization schedule for uncontrolled area