SOP for testing efficacy of antimicrobial disinfectant.
OBJECTIVE :-
Disinfectant used in the aseptic area and sterility testing area should be effective enough
to kill the organisms in that particular area
UNIT OF RESPONSBILITY :- QA Executive and trained QAAssistants
NOTE :-
a) Disinfectant should be used alternatively
b) Disinfectant should be checked for its effect disinfectant efficacy, for every consignment and every six months to ensure its effectivity
PROCEDURE :-
A) Material Requirement
1) Sterile Soyabean casien digest agar plates
2) Sterile distilled water
3) Sterile pipettes, test tubes and petri plates
4) Disinfectant to be tested
B) METHOD
1) Prepare 10 ml of different dilutions or different concentrations of disinfectant to be tested using
sterile distilled water
2) In each dilution, or different concentrations of disinfectant, add 1 ml of 24 hours old test culture
3) Keep the tubes at room temperature for 30 minutes
4) From each dilution of disinfectant or different concentration of disinfectant, a loopful of suspension
is streaked on sterile soyabean casien digest agar plates
5) Incubate the plates at 35 – 370C for 72 hours in inverted position and observe the plates for presence
6) Positive and negative control are kept along with test
7) Maintain the records terms of cfu in the given format Attachment-I
OTHER RELEVANT DETAILS:-
Disinfectants used are
1) Lysol solution
2) Dettol solution
3) Benzylalkonium chloride solution
Limits :- No growth of microorganisms should be observed in the selected range of disnfectant
PERSONNEL RO BE REPORTED IN CASE OF NON COMPLIANCE :- QA Executive
FREQUENCY OF OPERATION :- Every consignment and to be revalidated every six months
NO OF ATTACHMENTS:- One
RETENTION OF RECORDS:- 5 Years
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