- 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 |
