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Tuesday, August 11, 2009

SOP CLEANING ASEPTIC AREA STERILITY TESTING ROOM

SOP for cleaning sterility testing room
OBJECTIVE :- To clean the sterility testing room by removing the extraneous material and to disinfect the area making it condusive to carry out the operation

UNIT OF RESPONSIBILITY :- Trained QA personal

IMPORTANT POINT /NOTE /PRECAUTIONS :-

1 Handling of disinfectant should be done carefully

REQUIREMENT :-
1 25 % v/v dettol solution

2 25 % v/v lysol solution

3 01 % v/v benzalkonium solution ( BKC)

4 70 % v/v Isopropyl alcohol (IPA )

5 Lint free duster

6 Sterile gown and gloves


PROCEDURE :-

1 Prepare the solution of disinfectant of different concentration

2 Wear the sterile gown as mentioned in SOP for technique to follow in sterility testing room and
enter the room

3 Take about 25 litres of 25 % dettol solution and wipe then walls , the ceiling and then the floor
of the room with sterilised lint free duster, then wipe the walls ceiling and the floor with either
of the solutions mentioned :-

a) 25 % v/v lysol ( 25 ml of the lysol in 100 ml of DM water )

b) 01 % v/v bezalkonium chloride solution ( 1 m of BKC IN 1 L OF DM water)

4 Clean the table surface and the glasspanes and the laminar air flow bench with 70 % IPA
solution

5 After cleaning is over, spray the entire area with 70 % IPA solution

6 Come out of the sterility testing room and gown as per SOP for technique to follow in sterility
testing room

7 Record the cleaning details in the attachment 1

OTHER RELEVANT DETAILS :-
At the weekends fumigation is done with formalin and potassium permagnate powder
PERSONNEL TO BE REPORTED IN CASE OF NON COMPLIANCE :- Department head
FREQUENCY OF OPERATION :- The cleaning is done 3 times a week with alternate disinfactant

NO OF ATTACHMENT :-

RETENTION PERIOD OF RECORDS :- 5 years

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

Pharmaceutical Validation

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Determination of Phenol coeeficient of a disinfectant

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