sop for Fumigation of aseptic area and microbiology lab

 

 

1.0 : OBJECTIVE:

To lay down a procedure or fumigation and de fumigation of aseptic area and
Microbiology lab.

2.0 : RESPONSIBILITY

Microbiologist / Executive

3.0 : ACCOUNTABILITY

Q.C Manager

4.0 : PROCEDURE

: PRE –CHECKS

4.1.1 : Ensure that no Sterilized material is present in the area.

4.1.2 : Ensure that door of autoclave, opening into the sterile area are closed.

4.2 : FUMIGATION.
For transferring materials inside aseptic area follow S.O.P
4.2.1 : Partially open all the doors except entrance door leading to first Air lock.

4.2.2 : Connect the atomizer to the single phase socket and check its working.

4.2.3 : Take 500 ml of formaldeayde, dilute it with 500 ml of water for injection and pore it
Into the Atomizer.

4.2.9 : Switch off the AHU ,then after switch on the atomizer .

4.2.10 : Come out of the sterile area.

4.2.11 : Seal the entrance to the sterile area.

4.2.12 : Label the area is under fumigation entry is prohibited.

4.2.13 : Switch off the atomizer after 45 min.

4.2.14 : Run the AHU Blower for 5 minutes and put it OFF

4.2.15 : Keep the area in this condition over night.

PRECAUTIONS :
4.3 : Formalin is a strong irritant and is toxic inhalation of formaldehyde gas should
be avoided since it causes irritation of the respiratory tract. Contact with the
skin should also be avoided.

4.3.1 : When formalin is being handled protective clothing including gloves and
goggles must be worn.

4.3.2 : Effective fumigation requires a minimum temp. of 250 C and relative humidity
of at least 50% for the duration of fumigation.

4.3.3 : The area being fumigated must be completely shut off from other areas of the
Plant during fumigation.

4.3 : DE FUMIGATION

4.3.1 : De fumigate the area sufficiently before the days work starts.

4.3.2 : De fumigate by opening the exhaust air duct damper, 100% fresh air damper and
running the AHU blower.

4.3.3 : Once required operating conditions of sterile area is attained, shut the exhaust air
damper and partially open the fresh air damper.

4.3.4 : Once normal working conditions are attained monitor air pressure differential of the
area and record.

4.3.5 : Record the activity in fumigation and de fumigation log sheet.

N.P:- : Intense fumigation is to carried out after any maintenance work performed in the area
in the area or the AHU of the area is not under operation for more than 24 hrs. In this
case 0.5 ltrs of formaldehyde diluted with 0.5 ltrs of water.

5.0 : ABBREVIATION:

LAF = Laminar Air Flow.
AHU = Air Handling unit.

6.0 : REFERENCES :
In house