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Monday, August 10, 2009

TECHNIQUE FOLLOWED STERILITY TESTING ROOM

Standard operating procedure SOP for sterility testing room technique.

OBJECTIVE : To maintain the sterility testing room clean and tidy to carry out sterility tests and bioburden testing

UNIT OF RESPONSIBILITY :- QA Executive and trained QA Assistants
IMPORTANT POINTS /NOTES /PRECAUTIONS :-

1 Maintain personal hygiene
2 Strictly folow the Entry/ Exit procedure
3 The movement in the sterility testing room must be minimum Do not talk much
4 Do not use fountain pen, lead pencil, eraser in the area Use only ball point pen
5 Do not work in laminar flow unit when the UV lamp is on

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 starting the activity in laminar flow unit, keep the UV lamp on for 20- 30 minutes

Also start the gas burner

8 Spray the area with 70 % isopropyl alcohol before starting the operation

9 After completion of the operation put off the main LAF supply and the gas cylinder knob
before leaving the room

10 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

11 Put your normal clothing kept on the hanger Before opening the door of the airlock corfirm
that door of sterility room is closed

12 These uniform gloves are to be washed and resterilised before using for next operation
OTHER RELEVANT DETAILS :-

1 Fumigation of the rrom should be done weekly using formaldehyde solution and potassium
permagnate powder
2 Bioload of the area should be monitored by exposing sterile agar plates
PERSONNEL TO BE REPORTED IN CASE OF NON COMPLIANCE :- Department head

FREQUENCY OF OPERATION :- Operationwise

NO OF ATTACHMENT
RETENTION PERIOD OF RECORDS :  years

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

Pharmaceutical Validation

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

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