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Tuesday, August 11, 2009

HOW TO CHECK THE EFFICACY OF DISINFECTANT

HOW TO CHECK THE EFFECTIVITY OF DISINFECTANT

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

This Website is a Guide for Pharmaceutical Manufacturing validations Pharmacy Students Pharmacy Colleges and Pharmacists pharmaceutical companies and pharmaceutical industry  health care professionals 

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


Determination of Phenol coeeficient of a disinfectant


Pharmaceutical Validation

Cleen Room Classification

Pharmaceutical Industry

Pharmaceutical Manufacturing

Clinical Trials

Media fill

Pharmaceutical companies

Regulatory Affairs in Pharmaceutical Industry

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