Cleaning and Fumigation of Non-Sterile Areas


Cleaning and fumigation of non sterile area is required on their defined frequency by a validated disinfectant. Cleaning is comes under routine work but fumigation is required when a microbial load increases in controlled area air. To disinfectant the air a proper fumigation should be done

Frequency or When it to be done

  • Before start up of new / renovated Facility
  • After long shut down of the Facility.

Precautions to be taken

  • No process operation to be carried out during fumigation & cleaning.
  • All product related materials should removed
  • All the personnel shall follow entry/exit procedures.

Steps involved

  • Pre cleaning of area & Equipment : Clean the equipment as per the respective cleaning instruction, Clean all the rooms ,floor, ceiling and corridor with disinfectant solution.
  • Aerosilsation: Aerosilisation shall be done by using a disinfectant solution in all respective areas for 30 minutes, All AHUs of respective areas shall be in off condition. Minimum 2 hrs. should hold the same.
  • Post Aerosilisation cleaning: After Aerosilisation Walls, ceiling, floor & equipment should be cleaned by using lint free cloth.
  • Fumigation: Followings are the requirements & procedure for FumigationFumigant                        :   6 % W/V Hydrogen peroxide solutionAHU condition               :    Should be in ON position throughout

    Equipments                    :   SS Bowl ( Suitable size), Hot plate (up to 110ºC)

    Quantity of Fumigant    :   35 ml/cubic meter

    Duration                          :  Till all the fumigant solution vaporizes.

  • Post fumigation cleaning : By using lint free cloth with 70% v/v IPA,  wiping of entire area including equipment external surfaces should be done.
  • Cleaning and Sanitation of Floor drains:

Cleaning     : Detergent ( 2% solution)

Disinfectant : 10 % v/v Sodium Hypo chlorite solution.

Quantity       : 1 Liter / each part and leave for 15 minutes

Flushing      : Sufficient quantity of potable water.


Scheduling : Before start up of facility/every weekend during operation of production facility, after long shutdown


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