Custom Search

Tuesday, August 11, 2009


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


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

2 Use hand gloves while handling the formalin


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

2 Potassium paermagnate powder

3 Seprtating flask 125 ml capacity

4 Petridishes and Tripod stand


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


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


:- Weekly



Microbiology aseptic techniques

Guide for Pharmaceutical Manufacturing pharmacy students pharmacy colleges and pharmacists pharmaceutical companies in health care

Standard operating procedure SOP for microbiology and aseptic process

Following are some of articles which will be useful for you in further understanding of aspects of sterile dosage form manufacturing

Pharmaceutical Validations

Cleen Room Classification

Pharmaceutical Industry

Pharmaceutical Manufacturing

Clinical Trials

Media fill

Pharmaceutical companies

Regulatory Affairs in Pharmaceutical Industry

Determination of Phenol coeeficient of a disinfectant

1 comment:

ghanshyam said...

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

How to successfuly activate and receive our articles on pharmaceuticals by E-Mail

Dear readers if you wish to receive our articles on pharmaceutical automatically into your email Inbox , as and when we write a new article over this website, then follow these 3 simple steps.

1.You should write your Email ID in the box provided and push the subscribe button

2.Enter the text code that we show you in a small new browser window after you enter your email ID.

3.Log in to your email and Check our verification email sent by "FEEDBURNER" , there you should verify the link we send you by email.

Enter your email address get our articles by email whenever this website is updated

Delivered by FeedBurner

Join the list of our readers from Universities ,Research and
Development centers Pharmaceutical Companies from all over the world.

Pharma Research Regulatory Guidelines Website
Texas Dallas, TX 75211 US
Email: Website:
Copyright © 2008-2020 all rights reserve