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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

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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