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 was conducted in five original containers if a sufficient volume of product was available in each container, which can be accessed aseptically with the help of a syringe fitted with a needle. Otherwise, use five sterile capped bacteriological containers of suitable size to which a sufficient volume of the product has been transferred.
• Inoculate each container with one of the prepared and standardized inoculums by using a 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 are added to the product (categories 1, 2, and 3) is 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 (category 4) is 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 from 20°C to 25°C.
• Determine the viable count by using the plate count method at the 7th, 14th, 21st, and 28th days subsequent to inoculation (Note: incorporate an in the activator of the antimicrobial preservatives before the test).
• Record any change observed in appearance.

 

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Interpretation

• The preservative is effective in the product examined if the 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 remains 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-day test period.
• Prepare the report for the efficacy test as per the respective protocol.

Compendial product categories

ABBREVIATIONS:

QC: Quality Control

QA: Quality Assurance

SOP: Standard Operating Procedure

CFU: Colony Forming Unit

ANNEXURE

Nil

REVISION HISTORY

Nil

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