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Tuesday, August 11, 2009

FUMIGATION OF ASEPTIC AREA STERILITY TESTING ROOM

SOP for fumigation of Aseptic area sterlity testing room.
OBJECTIVE : To maintain the microbial load to a minimum of sterility testing room by fumigation by use of formalin and potassium permagnate powder

UNIT OF RESPONSIBILITY :- QA Executive and trained QA Assistants

IMPORTANT POINTS /NOTES /PRECAUTIONS :-

1 Handle the formalin solution carefully as it is corrosive in nature

2 Use hand gloves while handling the formalin


MATERIAL :-

1 Formalin solution 37 % ( 50 to 75 ml )'

2 Potassium paermagnate powder

3 Seprtating flask 125 ml capacity

4 Petridishes and Tripod stand


PROCEDURES :


1 Before entering into the airlock remove the footwear outside the room

2 Ensure that the door closes completely on releasing when you enter the airlock

3 Remove the normal clothing and put it on the hanger

4 Take one set of sterile uniform Wear sterile uniform as per the instructions given below

a) Put on the headgear

b) Put on the bushshirt and then pyjama

c) Headgear to be tucked into the bushshirt and the in turn to be tucked in the pyjama

d) Put on the footwear and tie it properly

e) Take the pair of sterile gloves of proper size and wear them properly

5 Rinse the gloved hands with 70 % Isopropyl alcohol

6 Open the door with care while entering the sterility testing room

7 Before the start of fumigation ensure that the Air handling unit is shut off to prevent

the fumes of formalin to enter the other areas through Air handling unit

8 Fill the seperator with suffficient quantity of 50 ml of formalin ( 1 : 1 )

9 Take around 25 gm of potassium permagnate powder in dry pertridish without lid

Keep the seperator filled with formalin on a tripod stand and the pertridish with potassium

below it at the centre of the area which is to be fumigated

10 Loosened the stopcock so that formalin will fall drop by drop on the potassium permagnate

powder

11 Immediately come out of the room, lock the door

12 While coming out remove the sterile uniform in the reverse order, that is fisrt gloves,

second footwear, third pyjama, and forth bushshirt and lastly the headmask

13 Put your normal clothing kept on the hanger Before opening the door of the airlock corfirm

that door of sterility room is closed

14 These uniform gloves are to be washed and resterilised before using for next operation

15 The fumigation record is recorded in the ataachment 1

PERSONNEL TO BE REPORTED IN CASE OF NON COMPLIANCE :- Department head


FREQUENCY OF OPERATION
:- Weekly


NO OF ATTACHMENT :-


RETENTION OF RECORDS :- 5 Years

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1 comment:

ghanshyam said...

formadehyde is carcinogenic so which other option to use for fumigation.........

Posted by: Martin

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