STANDARD OPERATING PROCEDURE Title: Fumigation Of Sterility Testing Suite With Formalin

Purpose:

To describe the procedure to conduct the fumigation in sterile areas.

2. Scope:

This procedure is applied whenever the fumigation of sterility testing suite is required.

3. Responsibilities:

1. Microbiologist

2. Lab Assistant

4. Procedure:

MATERIALS REQUIRED

1) Formalin 37%.

2) Hot plate Capable to heat from 400-500°C.

3) SS bowl 6-8 inch dia (sterile)

4) Measuring cylinder of 500 ml capacity.

5) Measuring cylinder of 100 ml capacity.

6) Funnel of appropriate size.

7) Rubber gloves.

8) Full face mask with filter for Formalin.

9) Skilled personnel for handling Formalin.

10) 2 inch dia scotch tap.

11) Potassium per magnate (if desired)

PRE-CHECKS

1) Check that the AHU is ‘off’.

2) Remove all the materials from inside of the suite which are not required in fumigation like all uniforms and sterility unit and its parts etc.

3) Place the informing tags on the entering doors.

PREPARATION OF FORMALIN

Dilute Formalin to 5% or as required using formula------- M₁V₁ = M₂V_2.

Potassium per magnate can be added if required.

PROCEDURE

1) Place the hot plate in the testing room.

2) Pour Formalin in the SS bowl and place over the hot plate.

3) Set the thermostat knob to approximately at two third position and ‘on’.

4) Connect the shoe of hot plate to the socket of the extension wire.

5) The other end of extension wire is taken out of the Micro-Lab and connected to the socket in the chemical hall. It will ease the person who is responsible to off the hot plate.

6) Confirm that the hot plate and socket switches are at ‘ON’ position.

7) Seal the outer door of sterility testing suite with tap.

8) Now “on’ the hot plate from the socket switch. Preferably it is done at the end of day’s work.

9) After about 2 hours a person responsible to off the hot plate will off the switch and will move out.

10) Leave the area as such for overnight or longer as Area Incharge decides.

11) The next morning a person goes in wearing full face mask to remove the tap.

12) After removing the tap, engineering staff is asked to run AHU.

PRECAUTIONS-

1) A second person with full face mask should always be there to assist the entering person in case of any accident.

2) In case of any injury immediately inform supervisor and get medical help as soon as possible.

3) Never let un-skilled persons to do the job.

4) Always wear goggles and gloves while handling the hazardous materials.

FREQUENCY

1) Fumigate the area once every fortnight.

2) When the area is disturbed.

3) After any maintenance work.

4) Power failure for more than 6 hours.