Cleaning of Dispensing Area during Product Changeover

Cleaning of Dispensing Area during Product Changeover

Objective

• To lay down a procedure for cleaning of dispensing area during product changeover to avoid cross-contamination.

Scope

• This SOP is applicable at Raw Material Store for cleaning of dispensing area during product changeover in formulation plant

Responsibility

• Raw material Store personnel shall be responsible to follow the procedure mentioned in this SOP.
• Raw material Store in-charge shall be responsible for implementation of the procedure mentioned in this SOP.

Accountability

• Raw material Store Incharge & QA Head shall be accountable for implementation of this SOP.

Abbreviations and Definitions

• QA                              :            Quality Assurance
• WH                             :            Warehouse
• RM                              :            Raw Material
• SOP                             :            Standard Operating Procedure
• AHU                           :            Air Handling Unit

Procedure

• • The area cleaning during Product Changeover:
    • Start the cleaning operation of ceiling and then to walls from top progressing to downwards.
    • Clean the door and window glasses using wet duster soaked with disinfectant solution.
    • Clean the doors, door closures, handles and all the hinges of the door using dry followed by wet duster and again with dry duster.
    • If weighing balance is present in the processing room, clean it by using wet duster followed by dry duster.
    • Clean the pallets, trolleys, etc. using a wet duster followed by a clean dry duster.
    • Remove the dust from the switchboards, utility pendants using the vacuum cleaner and wipe with clean dry duster.
    • Clean the SOP stand using clean dry duster.
    • Clean the accessories box using the wet duster followed by clean dry duster.
    • Clean the ceilings of Air Handling Unit (AHU) supply/return grilles with a pipe brush and vacuum cleaner.
    • Clean and mop the entire floor using disinfectant solution (2.5 % Dettol/Savlon) or any other disinfectant (if required)
    • Clean the tube light fixtures using wet duster followed by a clean dry duster.
    • Clean the coving, corners of the entire area using wet duster and followed by dry duster.
    • Clean the cameras of the entire area using wet duster followed by dry duster.
    • Clean the walls of the entire area using Disinfectant solution with wet mop.
    • Collect all the waste from the waste bin into a poly bag and send to the scrap area. Clean the waste bin with wet duster followed by dry duster.
    • Clean the drain points using disinfectant solution.
    • Enter the cleaning activity details in the Dispensing Area Cleaning Log Book.
    • The Cleaning for area shall be done during every product changeover.

Forms and Records (Annexures)

• Dispensing Area Cleaning Log Book                     –                     Annexure-I

Distribution

• Master copy       –    Quality Assurance
• Controlled copies –    Quality Assurance, Raw Material Store

History

 Annexure-I

Dispensing Area Cleaning Log Book

Note: All the observations of cleaning shall be recorded in cleaning record. If the cleaning activity  is satisfactory write ‘OK’, if not satisfactory write ‘NOT OK’ and if  not applicable  write ‘NA’

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