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SOP for Efficacy Test Procedure of Antimicrobial Preservatives


OBJECTIVE:
To lay down a procedure for testing the efficacy of the antimicrobial preservatives.

SCOPE:
This SOP is applicable to find out the efficacy of the preservatives added in formulations.

RESPONSIBILITY:
Microbiologist – Responsible for doing the activity.
QC Head – Responsible for implementing the procedure.
QA Head – Overall Compliance.


PROCEDURE:
Inoculation Procedure:
The test conducted in five original containers, if sufficient volume of product is available in each container, which can be accessed aseptically with the help of syringe fitted with needle. Otherwise use five sterile capped bacteriological containers of suitable size in to which a sufficient volume of product has been transferred.

Inoculate each container with one of the prepared and standardized inoculums by using sterile needle or syringe and mix the content for its uniform distribution.

The volume of suspension inoculum used is between 0.5 % and 1.0 % of the volume of the products.

The concentration of test microorganisms that is added to the product (categories 1, 2 and 3) are such that the final concentration of the test preparation after inoculation is between 1 x 105 and 1 x 106 cfu per mL of the product.

The concentration of test microorganisms that is added to the product (categories 4) are such that the final concentration of the test preparation after inoculation is between 1 x 103 and 1 x 104 cfu per mL of the product. Incubate the inoculated containers at 20°C to 25°C.

Determine the viable count by using plate count method at 7th, 14th, 21st and 28th days subsequent to inoculation (Note: incorporate an in activator of the antimicrobial preservatives before test).
Record any change observed in appearance.

 

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Interpretation:
The preservative is effective in the product examined if result is as follows.
The concentration of viable bacteria is not more than 0.1 % of the initial concentration by the 14th day.
The concentration of viable yeast and molds remain at or below the initial concentration during the first 14 days.
The concentration of each test organism remains at or below above designated levels during the remainder of the 28 days test period.
Prepare the report for the efficacy test as per respective protocol.

Compendial product categories:


ABBREVIATIONS:
QC: Quality Control
QA: Quality Assurance
SOP: Standard Operating Procedure
CFU: Colony Forming Unit

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