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
