Cosmetics

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

Submit samples for testing through ARL's Client Portal. 

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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).

Potency

This test measures the concentration of the active ingredient at a specific point in time.

Sterility by USP<71>

A sterility test detects microbial contamination. A satisfactory result indicates that no contaminating microorganism has been found in the sample examined under the conditions of the test.

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.

Challenge Testing - Antimicrobial Effectiveness Testing USP <51>

An antimicrobial effectiveness test demonstrates the effectiveness of antimicrobial preservatives in preventing microbial proliferation in injections, topicals, oral products, single dose vials, and antacids packaged in multiple-dose containers.

Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests USP <61>

These tests quantitate the total population of aerobic bacteria, yeast, and molds in raw materials, in-process samples, and finished products.

Microbiological Examination of Nonsterile Products: Tests for Specified Organisms USP <62>

These tests verify the absence of objectionable microorganisms in drug products and raw materials.

Microbial Identification

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

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.

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.

Water

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

All services provided will adhere to ARL Bio Pharma’s terms and conditions