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