Sop Fumigation in Sterile Area

 Objective
To lay down a procedure for fumigation in aseptic area.
 Scope
The SOP describes the procedure for fumigation in aseptic area.
 Responsibility
Production Officer / Executive shall be responsible for follow the procedure
mentioned in this SOP.
 Accountability
Production Head and QA head shall be accountable for compliance of SOP.
 Abbreviations
QA: Quality Assurance
PD: Production Department
 Procedure
Check that no activity is taking place in aseptic area.
Put the status label “Area under fumigation” at the entry door to aseptic area.
Remove any semi finished or finished material from the area.
 Clean the area as per SOP on cleaning and sanitization of aseptic area.
 Switch off the all the AHU’s before fumigation.
 Close all the fresh air supply and exhaust dampers and ensure that relative
humidity is between 40 to 50 % before fumigation.
 Fumigation operation.
 Fumigation is to be done after the days activities are over.

 Prepare the fumigation solution (20 % virosil pharma) as per SOP on
preparation of disinfectant solution.
 Clean the foggers as per SOP on operation and cleaning of fogger.
 Transfer the foggers to cooling area through pass box no as per SOP on
usage of dynamic pass box.
 As two foggers are used in aseptic area, fumigation is to be done as per the
following sequence.
 First in filling area, sampling area and cooling area.
 Second in sterile passage, entry change rooms and exit change rooms.
 Clean the area as per SOP on cleaning and sanitization of aseptic area.
 Switch off the all the AHU’s before fumigation.
 Close all the fresh air supply and exhaust dampers and ensure that relative
humidity is between 40 to 50 % before fumigation.
 Fumigation operation.

 Fumigation is to be done after the days activities are over.
 Prepare the fumigation solution (20 % virosil pharma) as per SOP on
preparation of disinfectant solution.
 Clean the foggers as per SOP on operation and cleaning of fogger.
 Transfer the foggers to cooling area through pass box no as per SOP on
usage of dynamic pass box.
 As two foggers are used in aseptic area, fumigation is to be done as per
the following sequence.
 First in filling area, sampling area and cooling area.
 Second in sterile passage, entry change rooms and exit change rooms.
 Transfer 4000 ml solution to first fogger (Capacity 5 Lit.) and 2500 ml
solution to the second fogger (Capacity 3 Lit.)
 Bring the first fogger with 4000 ml solution in filling area.
 Set the time in the fogger for 50 minutes for complete fumigation in filling
area with flow rate 41.6ml/min.
 After complete fumigation in filling area then immediately bring the fogger
for fumigation in sampling area.
 Set the time in the fogger for 12 minutes for complete fumigation in
sampling area.
 After complete fumigation in sampling area then immediately bring the
fogger for fumigation in cooling area.
 Set the time in the fogger for 35 minutes for complete fumigation in cooling
area.
 Keep the fogger in one corner of the room at a height of 2 feet above
ground level.
 Keep the nozzle at an angle of 45 degrees from horizontal.
 Switch on the main power supply and exit the room immediately for each
room.
 Bring the second fogger with 2500 ml solution in sterile passage.
 Set the time in the fogger for 25 minutes for complete fumigation in sterile
passage.
 Transfer 4000 ml solution to first fogger (Capacity 5 Lit.) and 2500 ml
solution to the second fogger (Capacity 3 Lit.)
 Bring the first fogger with 4000 ml solution in filling area.
 Set the time in the fogger for 50 minutes for complete fumigation in filling
area with flow rate 41.6ml/min.
 After complete fumigation in filling area then immediately bring the fogger
for fumigation in sampling area.
 Set the time in the fogger for 12 minutes for complete fumigation in
sampling area.
 After complete fumigation in sampling area then immediately bring the
fogger for fumigation in cooling area.
 Set the time in the fogger for 35 minutes for complete fumigation in cooling
area.
 Keep the fogger in one corner of the room at a height of 2 feet above
ground level.
 Keep the nozzle at an angle of 45 degrees from horizontal.
 Switch on the main power supply and exit the room immediately for each
room.
 Bring the second fogger with 2500 ml solution in sterile passage.
 Set the time in the fogger for 25 minutes for complete fumigation in sterile
passage.
Conc. of disinfectant Volume of dilution
Sr.No. Area used
to be used to be
01 Filling area 20 % 2000 ml
02 Cooling area 20 % 1500 ml
03 Sterile Passage 20 % 1000 ml
04 Sampling room 20 % 500 ml
05 Entry change rooms 20 % 1000 ml
06 Exit change rooms 20 % 500 ml

 De – fumigation operation
 Ensure the area remains undisturbed for minimum 7 hours.
 Open the fresh air supply dampers and exhaust dampers next morning. Close
the recirculation dampers.
 Switch on all the AHU‘s of the area.
 Do not enter the aseptic area before 30 minutes of starting the AHU’s.
 After 30 minutes close the exhaust dampers and open the recirculation
dampers.
 Frequency on daily basis
 Record shall be done.
 After major shutdown.
 After change or modification in major equipment /HVAC system.
 If the microbial count are more than acceptance limit.
 After media fill trials. (Decontamination after media fills trials is to be done on
three consecutive days).
 The batch filling process should be started only after getting the satisfactory
report of plate count and particle count of three consecutive days.
 Forms and Records (Annexures)
 Fumigation record of aseptic area – Annexure-1
 Distribution
 Master copy – Quality Assurance
 Controlled copies- Quality Assurance, Production, Quality Control

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 Objective

To lay down a procedure for fumigation in aseptic area.

 Fumigation is to be done after the days activities are over.

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