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.

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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Endotoxin USP <85>

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

Fungal

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.

USP <61> and USP <62> Microbial Tests for Non-Sterile 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.

USP <61> and USP <62> Microbial Tests for Non-Sterile Products

Growth Promotion

Growth Promotion demonstrates that media used in environmental monitoring programs, media fills, or personnel qualification are capable of supporting microorganism growth.

Growth Promotion Sample Submission form

Growth Promotion Testing

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.

Container Closure Testing

The container closure system for a drug product provides critical protection for stability and sterility. ARL offers USP <1207> container closure integrity testing (CCIT) on IV bags, syringes, and vials. Three types of leaks that can be detected during CCIT include: 

 

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