Antimicrobial preservatives are substances added to aqueous pharmaceutical products. Nonsterile dosage forms may have preservatives added to protect them from growth of microorganisms inadvertently introduced during or subsequent to the manufacturing process. In the case of sterile articles packaged in multiple-dose containers, antimicrobial preservatives are added to inhibit the growth of microorganisms that may be introduced from repeatedly withdrawing individual doses. One or more antimicrobial preservatives are expected in all sterile multidose units.
Scientech Labs performs Antimicrobial Effectiveness Testing to ensure your products meet regulatory standards
Antimicrobial effectiveness, whether inherent in the product or produced because of the addition of an antimicrobial preservative, must be demonstrated for all products containing antimicrobial preservatives before they are introduced to the market per government regulations.
Although there are various methodologies utilized to test Antimicrobial/Preservative Efficacy, their basic concept is the same. The test samples are challenged with a standard panel of microorganisms including Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Candida albicans, and Aspergillus brasiliensis. Enumeration is performed at regular time points over a 28-day period.
USP <51> is divided into 4 categories including Injections, Topical Products, Oral Products in aqueous bases, and Antacid products. Hence, it is typically used to test pharmaceutical products, but many personal care companies also test their products under the topical products category.
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