Microbiology Testing

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.

• Method Suitability and Its Importance to the Test Method
• Sterility Test Failure: Possible Causes and Investigation
• Basics of Sterility Testing
• Open vs Closed Membrane Filtration Systems
• USP 71 Sterility Testing

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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• Rapid Sterility Testing
• Rapid Sterility Testing for Compounding Pharmacies

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

• The Importance of Endotoxin Testing
• Endotoxin Essentials
• USP <85> Bacterial Endotoxin Validation and Its Importance to the Test Method

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

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

• Prevent Future Sterility Failures by Identifying Contaminating Microorganisms
• How Does Microbial ID Benefit Your Pharmacy?

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.

• The Essentials of USP <51>
• USP <51> Antimicrobial Effectiveness Testing

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

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 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 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.

• Microbial Disinfectant Cleaning Challenge Studies

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, cassettes, and vials. Three types of leaks that can be detected during CCIT include: 

1. Entry of microorganisms
2. Escape of the product dosage form or entry of liquids or solids
3. Escape of nitrogen gas or entry of oxygen, water vapor, or air gases
    

• Container Closure Integrity Testing - vacuum decay test method
• Container Closure Integrity Testing - dye ingress test method