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SOP for Cleaning and Disinfections of Processing Areas

OBJECTIVE
To provide a cleaning and disinfection procedure for processing areas in order to maintain a tidy and safe working environment, to remove dust and dirt which may affect product quality, to avoid the risk of cross contamination and to control bio burden in the production area.

SCOPE
It applies to all the processing areas of XYZ Limited.

RESPONSIBILITY
Operator: To cover the product before cleaning and disinfection & clean the machine / equipment lying in the processing cubicle as per the respective SOP’s.
Cleaners: Cleaning and disinfection operation of processing cubicles.
Production Supervisor: To check the cleaning and disinfection operation.
Q.A. Personnel: To verify the cleaning and disinfection operation periodically and at the time of certifying area clearance for respective operation.

PROCESSING AREAS:
  1. Granulation and drying room
  2. Capsule filling room
  3. Tablet compression room
  4. Blending room
  5. Liquids production and packing
  6. Bulk packing
  7. Dispensing room

PRECAUTION
  • The cleaning agents and disinfectants require careful handling and protective gears must be used while handling them.
  • They should not be mixed together as some of the mixture may be chemically reactive or may reduce anti microbial activity.
  • They should be used in freshly diluted form as their efficiency may reduce on prolonged storage.

PROCEDURE
Cleaning procedure for processing areas during batch change over, once in a shift and at the start /end of the day/ as and when required.
  • Wear face mask and surgical gloves.
  • Ensure that status label of machine and area is fixed.
  • Arrange the area, tie the polythene bag with nylon thread in case of capsules, residue etc and segregate the product on pallet.
  • In case of batch change over remove all materials of previous batch.
  • Ensure that all the containers are covered with their lids.
  • Clean the machines of respective processing cubicle as per their respective SOPs.
  • Clean the floor with vacuum cleaner followed by wet moping using cleaning agent: after which the floor shall be dried by mopping.
  • Dispose the contents of the dustbin.
  • Record the cleaning on the log sheet attachment I.
  • Clean the mops with water, and the cleaning agent, rinse with purified water and allow to dry.
  • Clean the vacuum cleaner as per SOP.

Cleaning procedure for processing areas during product change over.
  • Wear face mask and hand gloves.
  • Ensure that status label of machine and area is affixed.
  • Ensure that all the containers are covered with their lid.
  • Remove all the materials of the previous product/ batch.
  • Clean the machine of respective processing areas according to product changeover as per their respective SOPs. Clean the weighing balance as per the respective SOPs.
  • Clean the entire processing room walls, floor, door, ceiling, glass panels and view panels with vacuum cleaner to remove the powder, followed by wet mopping and then dry mopping with lint free clean cloth.
  • Clean the return riser filter as per SOP.
  • Wipe the dust extraction pendent with wet mopping followed by dry mopping.
  • Clean the electric components like switches, plug tops, cable and the switch board with a clean dry cloth.
  • Decontaminate the non-recoverable residues and Dispose the contents of the dustbin.
  • Clean the floor with vacuum cleaner followed by wet mopping using an appropriate 1%v/v Cleaning agent solution after which dry the floor by mopping.
  • Record the cleaning on the cleaning log sheet.
  • Clean the mop with1% v/v of cleaning solution followed by purified water, air dry.
  • Clean the vacuum cleaner as per SOP.

Periodical cleaning procedure for processing areas in a shift/day.
  • Clean the glass panel, door, walls, electric components, and dustbin once a shift and the twice a day as under.
  • Clean the glass panel, door and walls with Colin and lint free cloth.
  • Wet mop with lint free cloth followed by dry mopping.
  • Clean the electric components like plug tops, cables, switchboards with a clean dry cloth.
  • Clean the inner and outer side of dustbin by scrubbing with lint free cloth soaked in 1% v/v of cleaning solution followed by rinsing with purified water.
  • Record the cleaning on the cleaning log sheet.

Disinfection Procedure.
  • Disinfection of processing areas shall be done once in a shift only when there is no product inside the areas.
  • Thoroughly clean the processing areas as per above procedure followed by wet mopping using a chosen disinfectant.
  • After disinfection dry the floor by mopping.
  • Maintain the disinfection record by logging on the log sheet.
  • Clean the mop with aqueous solution of Liquid Soap followed by water and air dry it.

ATTACHMENTS
Cleaning Log Sheet: Attachment 1.

 
ABBREVIATION
SOP - Standard Operating Procedure.

REVISION HISTORY
Nil

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