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.
- 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