Cosmetics

ARL Bio Pharma provides analytical and microbiological testing for cosmetic manufacturers and suppliers.

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Stability Studies

A stability study measures the extent to which a product retains, within specified limits, and throughout its period of storage and use, the same properties and characteristics that it possessed at the time of compounding.

A study commonly includes: a stability indicating method assay, sterility (for sterile preparations), endotoxin (for most sterile preparations), pH, visual inspection, particulate matter, preservative effectiveness, preservative quantification, microbial limits (for non-sterile preparations), and the absence of specified organisms (for non-sterile preparations).

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Rapid Sterility

A rapid sterility test detects microbial contamination. This validated alternative sterility test method per USP <1223> is effective and reliable for 503A and 503B Facilities. Rapid test provides objective results in as little as six days.

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Challenge Testing - Antimicrobial Effectiveness Testing USP <51>

Microbial Identification

This test identifies microorganisms isolated during different phases of manufacturing and quality testing to the genus/species level using DNA sequencing.

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Microbial Disinfectant Cleaning Challenge Studies

Microbial cleaning studies are essential to validating a facility’s cleaning SOP.  Cosmetic manufacturers and suppliers must demonstrate that cleaning agents, combined with instructions and procedures for their use, remove microbial contamination from surface areas where cosmetic products are produced.

 

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Raw Materials

Qualify drug substances, excipients, and drug products to meet pharmacopeia specifications

Particulate Matter

A particulate matter tests for the presence of extraneous substances including: dust, glass, drug precipitates, rubber and other insoluble materials.

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Water

The determination of water content is important in demonstrating compliance with Pharmacopeial standards.