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SOP on Fumigation in Aseptic 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.
  • 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.
  • After complete fumigation in sterile passage then immediately bring the fogger for fumigation in entry change rooms.
  • Set the time in the fogger for 25 minutes for complete fumigation in entry change rooms.
  • After complete fumigation in entry change rooms then immediately bring the fogger for fumigation in exit change rooms.
  • Set the time in the fogger for 12 minutes for complete fumigation in exit change rooms.
  • 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.
  • Note the fumigation details in the Fumigation record of aseptic area, specimen attached with annexure-1
  • Fumigation solution to be used as per the table given below;
Sr.No. Area used Conc. of disinfectant to be used Volume of dilution 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
  • History
    Date Revision Number
    Reason for Revision
    00 New SOP

Annexure-1

Fumigation Record of Aseptic area

Date: _____________

 Preparation and filtration of disinfectant solution and water for injection:

Contents  Quantity taken in ltr Transferred and filtered by Checked By

 

Virosil Pharma (Conc.)
Water for Injection

Dilution in aseptic area

Name of disinfectant Conc.Qty in ltr Qty of WFI in Ltr. Total quantity of solution taken in ltr. Prepared by Checked by
Verosil pharma(Conc.)

 

Solution used (Conc. in v/v %) :
Location  Solution used in (ml)  Fumigation Done by  Fumigation Checked by
Filling Room
Cooling room
Sterile Passage
Sampling room
Entry Change rooms
Exit change rooms

 

Prepared By / Date Checked By / Date Approved By / Date – QA

 

 

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