Antimicrobial Effectiveness Test (Preservative Efficacy Test)

Welcome to Microbiology Testing Services of Shubhda Research Institute –Simulation Studies information page.

The information and outline given below is only for presenting the gist of the method to sponsors intending to test their product and is purely for educational purpose.


This test was previously known as Preservative Efficacy Test which is performed to determine if the chosen preservative is appropriate for a product formulation. It is also carried out as part of a stability study, to ascertain whether a preservative system is still effective up to the expiration date of a product. Testing is performed according to pharmacopeial methods as in USP <51> and EP 5.1.3.,or by Ph. harmonized method.

Four categories of the products are tested:

Injections, nasal ,otic OR Ophthalmic preparations with aqueous base

Topically used products with aq. Base

Oral products other than antacids in aq. Base

Antacids with aqueous base.

The Sample is inoculated with a specified quantity of each test microorganisms separately. The initial count of microorganisms is compared with that at various time intervals ranging from 0 hr, 6 hr 1 day and so on, over a period of 28 days at a specified temperature. Log Reduction of microorganisms is calculated and used to evaluate the antimicrobial effectiveness of the product.

Organisms used;

E. coli ATCC 8739

S. aureus ATCC 6538

P. aeruginosa ATCC 9027

C. albicans ATCC 10231

A. niger ATCC 16404

S. typhi ATCC 14028

C. sporogenes ATCC 19404

Turn Around time: 35 days

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