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Antimicrobial Effectiveness Test

Antimicrobial effectiveness

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Vijay Sakhare
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52 views8 pages

Antimicrobial Effectiveness Test

Antimicrobial effectiveness

Uploaded by

Vijay Sakhare
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
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ANTIMICROBIAL EFFECTIVENESS

TEST

Dr. Utpal Mohan


WHAT IS THE ANTIMICROBIAL
EFFECTIVENESS TEST?

• Referenced in the current USP and IP, the Antimicrobial


Effectiveness Test demonstrates the effectiveness of the
preservative system in a product.

• A product is inoculated with a controlled quantity of


specific microorganisms.

• The test then compares the level of microorganisms found


on a control sample versus the test sample over a period of
28 days.
WHAT IS AN ANTIMICROBIAL
PRESERVATIVE?
• Antimicrobial preservatives are substances added to non-sterile
dosage forms to protect them from microbiological growth or
from microorganisms that are introduced inadvertently during or
subsequent to the manufacturing process.

• In the case of sterile articles packed in multiple-dose containers,


antimicrobial preservatives are added to inhibit the growth of
microorganisms that may be introduced from repeatedly
withdrawing individual doses.

• Examples of antimicrobial preservatives include alcohol,


formaldehydes and iodine.
PRODUCT CATEGORIES
• For testing purposes, the USP has divided test articles into
four separate categories:
• Category 1 – Injections, other parenterals including
emulsions, otic, sterile nasal products made with aqueous
bases or vehicles.
• Category 2 – Topically used products made with aqueous
bases or vehicles, non-sterile nasal products, and emulsions,
including those applied to mucous membranes.

• Category 3 – Oral products other than antacids made with


aqueous bases or vehicles.

• Category 4 – Antacids made with an aqueous base.


TEST ORGANISMS
• When performed according to USP, five indicator organisms are utilized for the
purpose of challenging the preservative system in a product.

• Three of the five USP indicator organisms, Escherichia Coli, Pseudomonas


aeruginosa, and Staphylococcus aureus, address the growth of bacteria.

• Candida albicans is the representative yeast, while Aspergillus brasiliensis is a


mold.
• Test organisms: The following test organisms are used in the test. Candida
albicans ATCC 10231; Aspergillus brasiliensis ATCC 16404; Escherichia coli ATCC
8739; Pseudomonas aeruginosa ATCC 9027; Staphylococcus aureus ATCC 6538.
• The above listed microorganisms are ATCC cultures and must be harvested
under current USP guidelines to assure viability. (Other organisms can be
incorporated into the test as customer and product needs dictate.)
• A product is inoculated (contaminated) with a number of organisms between 1
x 105 (100,000) to 1 x 106 (1,000,000) colony forming units (CFU) per mL of
product. At various intervals, depending on the category, the product is tested
to determine its ability to control reproduction or destroy the microorganisms.
• PRODUCT CRITERIA
– A logarithmic reduction is evaluated at each test interval required for the category. By
test definition, any growth over the allotted amount for any of the indicated
microorganisms renders the preservative in the product not effective.

• WHEN DOES A PRODUCT NEED AN ANTIMICROBIAL EFFECTIVENESS


TEST?
As part of a stability study, it is beneficial to determine if a preservative system will
stand up to the product’s shelf life. It may also be beneficial to determine if the preservative
system chosen for a product is compatible with the formulation of the product. The
procedure is intended for a self-contained finished product.

• It is necessary to retest the effectiveness of the preservative system any time the formulation
is changed or when significant product or packaging changes occur.
Log reduction
Log reduction is a mathematical term that is used to express the relative number of living
microbes that are eliminated by disinfection.
Log reduction = log10 (N0 /N)
Where:
N0 = colony forming units of the microorganisms before exposure to UV light
N = colony forming units of the microorganisms after exposure to UV light
For example, a 1 log reduction corresponds to inactivating 90 percent of a target microbe
with the microbe count being reduced by a factor of 10. Thus, a 2 log reduction will see a
99 percent reduction, or microbe reduction by a factor of 100, and so on. Table 1 (below)
shows the chart of log reduction.
Log Reduction Percent
Reduction Factor Reduced
1 10 90%
2 100 99%
3 1,000 99.9%
4 10,000 99.99%
5 100,000 99.999%
6 1,000,000 99.9999%
HOW MUCH PRODUCT IS REQURIED?
• If a product is submitted in liquid form, a volume of not less
than 20 ml is preferred. When submitting granular or
powdered dosage forms, a weight of 20 grams is preferred.

• The validation of this product requires an additional 100 mL


or grams. At the time of product submittal, it is necessary to
note the category to be tested for the product.

• Testing Time Intervals; under normal condition, the


turnaround time to perform the Antimicrobial Effectiveness
test is 7 weeks due to incubation requirements.

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