Scope: This SOP applies to all personnel involved in the microbiology of pharmaceuticals.
Responsibility: The responsibility of performing the disinfectant efficacy test lies with the microbiology department.
Accountability: The Quality Control (QC) department is accountable for the compliance of the disinfectant efficacy test with this SOP.
Procedure:
Preparation of Inoculum: Collect the microorganisms to be used in the efficacy test.
Inoculate the microbial culture suspension in nutrient broth or soybean
casein digest medium and incubate at 32°C±2.5oC for 24 hours.
Adjust the concentration of the inoculum according to the required dilution factor.
After 24 hours again inoculate the same microbial culture suspension by
transferring a loop full of the previous suspension on soybean casein digest agar
for 48 hrs to refresh the microbial culture.
Prepare the inoculum using aseptic techniques and standard procedures, and the suspension in sterile normal saline to achieve 105/ml.
Serially dilute the freshly reconstituted microbial culture to get
25-250 CFU/plate.
Preparation of Disinfectant Dilutions in Different Concentrations: Prepare the disinfectant solution as per the manufacturer's instructions, the serial dilutions of disinfectant from 0.5%-5%.
Carefully add 1 ml of the microbial culture suspension with 25-250CFU
count to each serial dilution of the disinfectant solution and shake properly.
Label the disinfectant solutions and dilutions properly.
Set the dilutions containing microbial suspension with
disinfectant for 10 minutes.
Performing the Test: Inoculate the microorganisms in the disinfectant dilutions.
Incubate the inoculated disinfectant solutions for a specific time at a specified temperature.
After 10 minutes take 1 ml of solution from each serial dilution tube and
transfer to tubes containing 20-25 ml of a sterile nutrient agar with
neutralizer and mix properly.
Let the plate solidify and incubate at 32°C ± 2.5°C for 48-72
hrs.
After the specified time, neutralize the disinfectant using a neutralizer solution.
Transfer the neutralized inoculated disinfectant solutions onto agar plates.
Incubate the agar plates for a specified time at a specified temperature.
Record the results.
Reading and Recording the Results: Check for the presence or absence of microbial growth on the agar plates.
Count the number of viable microbes/plates after the completion of the incubation period and record the results.
Calculate the log reduction value of the disinfectant for each dilution.
Compare the log reduction values with the acceptance criteria.
Record the results.
The inactivators or neutralizers such as sodium thiosulphate (5% w/v
solution), and lecithin (0.5%) with tween-20 (4%) must be used for inactivation
purposes depending on the type of disinfectant used
Specifications: The log reduction value should meet the acceptance criteria.
Specifications: The log reduction value should meet the acceptance criteria.
Recovery of microbial culture should be NMT10%.
The disinfectant efficacy test should be performed in compliance with this SOP.
Records: Records of disinfectant efficacy tests should be maintained.
The records should include the details of the microorganisms used, disinfectant dilutions, incubation conditions, and results.
References: USP <1072> Disinfectants and Antiseptics.
ASTM E2315 - Standard Guide for Assessment of Antimicrobial Activity Using a Time-Kill Procedure.
Distribution: This SOP should be distributed to all personnel involved in the microbiology of pharmaceuticals.
END OF THE DOCUMENT
The disinfectant efficacy test should be performed in compliance with this SOP.
Records: Records of disinfectant efficacy tests should be maintained.
The records should include the details of the microorganisms used, disinfectant dilutions, incubation conditions, and results.
References: USP <1072> Disinfectants and Antiseptics.
ASTM E2315 - Standard Guide for Assessment of Antimicrobial Activity Using a Time-Kill Procedure.
Distribution: This SOP should be distributed to all personnel involved in the microbiology of pharmaceuticals.
END OF THE DOCUMENT
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