Antimicrobial Preservative Efficacy Testing

Antimicrobial Effectiveness Tests, or Preservative Effectiveness Tests, are performed to determine the efficacy of the antimicrobial preservatives added to many pharmaceutical and cosmetic products to prevent contamination over a period of time. Products are challenged with microorganisms either determined by the specific guidance criteria or chosen for relevance to the product, and the product is sampled at different time intervals over the course of not less than 28 days. There are several different guidance documents that address the Preservative Efficacy Testing and criteria such as U.S. Pharmacopeia <51>, European Pharmacopeia 5.1.3, International Organization for Standardization (ISO) 11930 and Personal Care Products Council (PCPC) M-3 and M-4. Although these guidance documents are very similar, different criteria are called out in each one. In addition, many manufacturers choose to design custom assays designed to address specific contamination risks for their product. Typically, a neutralization validation is also performed as part of the assay, however, manufacturers will occasionally perform the assay without performing the neutralization during the product formulation phase to determine the most effective concentration to add to the formula. BioScience Laboratories recommends always performing the neutralization validation step whenever you are conducting a preservative efficacy test.

The Antimicrobial Preservative Efficacy test measures the effectiveness of antimicrobial preservatives added to nonsterile dosage forms or multi-dose containers in order to inhibit the growth of microorganisms that may be introduced inadvertently, either during the manufacturing process or product use.

Antimicrobial effectiveness must be demonstrated on all injections packaged in multiple-dose containers, multiple-dose topical and oral forms, and other dosage forms which contain antimicrobial preservatives. This test should be performed on all aqueous-based products that include ophthalmic, otic, nasal, oral, irrigation, and dialysis fluids.

Testing performed by Nelson Labs meets the criteria set forth by the USP General Chapter 51 on Antimicrobial Effectiveness Testing. This test can also be performed to comply with requirements detailed in the European Pharmacopoeia or other international standards. We have extensive experience working with the USP organisms, as well as an excellent understanding of preservative systems and effective neutralization techniques. We provide scientifically sound data by plating in triplicate and offering multiple replicate testing. We also have the resources to test samples with minimal wait time.

ASTM

These are among the most commonly used ASTM methods, please note that these are not our only capabilities. After discussing your needs with our experts, we are able to purchas...

ASTM - E640

Standard Test Method for Preservatives in Water-Containing Cosmetics This test method covers the determination of the suitability of preservatives for use in cosmetic formulat...

USP

The U.S Pharmacopoeia Convention (USP) is a scientific organization that sets standards for products distributed and consumed worldwide. These standards are used in many count...

USP - 51

ANTIMICROBIAL PRESERVATIVE EFFECTIVENESS TEST (PET) The U.S. Pharmacopeia describes in General Chapter 51, the assay they recommend for testing preservative efficacy. The USP ...

EN

European Standard (EN) are documents that globally recognized that define best practices and requirements for test-methods. This is a list of BSLI’s most commonly practiced EN...

EP 5.1.3

The European Pharmacopeia describes in General Text 5.1.3, the assay they recommend for testing preservative efficacy. The EP divides products into three tables: 5.1.3-1 - Par...

ISO Standards

ISO standards are a set of guidelines that ensure quality, safety and efficiency for you products. This is not a complete list of BSLI’s capabilities, connect with our experts...

ISO 11930

The International Organization for Harmonization is designed for cosmetic formulations. Unlike the USP 51 or EP 5.1.3, ISO does not divide products into different categories. ...

PCPC

PCPC (formerly referred to as Cosmetic, Toiletry and Fragrance Association or CTFA): The Personal Care Products Council provides guidance for preservative efficacy testing in ...

Personal Care Products Council (PCPC)

Preservation Testing of Water-Miscible Products Challenge testing a formula with known microorganisms to verify that if the products become contaminated, the preservative syst...

In-Vitro Testing Laboratory

Scientists in our In-Vitro testing labs are well trained on ASTM, AATCC, AOAC, CLSI and EN standard methods. The efficacy testing services of this laboratory include MIC/MBC, ...