If you are involved in the manufacture of cosmetic and personal care products, you need to ensure that your products are safe and free of microbial contamination. This can only be achieved through use of a sound quality assurance and control program.

BioSpectrum offers the service of an experienced test laboratory for the cosmetic and personal care industries to ensure that products are safe for consumer use, properly preserved and free of objectionable microorganisms. Our staff of highly qualified scientists and technicians can help you in the development and troubleshooting of your formulations.

Our broad menu of assays include: CTFA challenge testing (test protocol includes two challenges with high-count pools of bacteria, yeast and mold), Microbial Content, MIC Test, Kill-Time Studies and Protocol Development.

We have the experience to recommend alternative preservative systems .

Recently, we have incorporated a Rapid Challenge Test that will help you determine the optimum concentration of preservative or check how well an early stage formulation is performing ? in one week.USP Challenge Testing is available. Neutralization Efficacy and Toxicity assays are also performed.

Microorganisms need water to grow. Determining the free water available in your product is a useful tool for avoiding over-preservation. We now perform Water Activity analysis to help you know in advance which organisms may cause problems in your formulation and adjust levels of your preservative system accordingly.
Interim results are promptly faxed and non-conforming results are discussed with our clients.

Our testing can also be integrated with in vivo and in vitro testing, analytical and formulation services. We can provide you with a complete program for product research and development.

Microbiology Assays

▶ Aerobic Plate Count (APC) and Yeast and Mold Count: Determines the microbial content of cosmetic products by CTFA Method M-1 and M-2 and FDA Bacteriological analytical Manual.
▶ Enrichment: Tests for sterility by culturing the test sample in a specific enrichment broth containing a preservative neutralizer (FDA Bacteriological Analytical Manual).
▶ Antimicrobial Effectiveness Test (Challenge Test): Microbial challenge of test material (CTFA Method M-3 and M-4).
▶ Rapid Challenge Test: Microbial challenge test by a Modified Linear Regression Method.
▶ USP Challenge Test: Microbial challenge test by USP XXIV method.
▶ Minimum Inhibitory Concentration (MIC): Determines the lowest concentration of test agent inhibiting visible growth. Useful in screening novel preservatives against a variety of organisms.
▶ Disk Diffusion Assay: Determines microbial susceptibility to a test agent by measuring “zone of inhibition” forming around a test agent on a “seeded” agar plate.
▶ Use-Dilution, Fungicidal and Sporicidal Tests: Determines the effectiveness of disinfectants and sterilants against designated organisms by AOAC methods.
▶ Oral Rinse Efficacy: Determines antimicrobial efficacy in vitro per the FDA Oral Health Care Monograph. ▶ Topical Antimicrobials: Evaluation of topical antimicrobial products for in vitro effectiveness by the FDA Monograph.
▶ Water Activity Measurement: Aw is the ratio of the water vapor pressure over a product to that over pure water.