SOP for Cleaning and Disinfection of Facemask Production Area

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 the bioburden in the production area.

SCOPE
It applies to the mask production area.

RESPONSIBILITY
Cleaners: Cleaning and disinfection operation of the processing area.
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 operations.

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 a batch changeover, once in a shift and at the start /end of the day/ as and when required.
  • Wear a facemask and surgical gloves.
  • Ensure that the status label of the area is fixed.
  • Remove all materials from the previous batch.
  • Ensure that all the containers are covered with their lids.
  • Clean the machines for mask production as per their respective SOPs.
  • Clean the floor with a broom to remove any offcuts and debris and put in the dustbin.
  • Vacuum clean to remove dust than wet moping using 1% v/v soap solution: after which the floor shall be dried by mopping.
  • Dispose of 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 clean water and allow drying.
  • Clean the vacuum cleaner as per SOP for Operation and Cleaning of Vacuum Cleaner.

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 lint-free cloth.
  • Wet mop with lint-free cloth followed by dry mopping.
  • Clean the electric components like plug tops, cables, and switchboards with a clean dry cloth.
  • Clean the inner and outer side of the 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 twice in a shift at the beginning and end.
  • Use the disinfectant of the day as per the disinfectant cycle procedure.
  • Thoroughly clean the processing areas as per the above procedure followed by wet mopping using a chosen disinfectant.
  • After disinfection dry the floor by mopping.
  • Maintain the disinfection record by logging on to the log sheet.
  • Clean the mop with an aqueous Liquid Soap followed by water and air dry it.

ATTACHMENT
Attachment 1: Cleaning Log Sheet.

ABBREVIATION
SOP: Standard Operating Procedure.

REVISION HISTORY
Nil

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