Microbiology Testing

Sterility 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.

Endotoxin USP <85>

An endotoxin test detects toxins that are released from the cell wall of disrupted gram-negative bacteria.


This test is designed to increase the likelihood of detecting fungal microorganisms in sterile products.

Microbial Identification

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

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 Disinfectant Cleaning Challenge Studies

Microbial cleaning studies are essential to validating a facility’s cleaning SOP.  Pharmacies must demonstrate that cleaning agents, combined with instructions and procedures for their use, remove microbial contamination from surface areas where sterile drug products are compounded.

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