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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.
Articles:
- Applications and Sterility of Autologous Serum Eye Drops
- Basics of Sterility Testing
- Laboratory Considerations of USP Chapter 71 Sterile Tests
- Method Suitability and Its Importance to the Test Method
- Open vs Closed Membrane Filtration Systems
- Sterility Test Failure: Possible Causes and Investigation
- The Importance of Sterility Test Volume and Method Suitability Testing
- USP 71 Sterility Testing
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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.
Articles:
- Dispense Drugs Faster with Rapid Sterility
- Rapid Sterility Testing
- Rapid Sterility Testing for Compounding Pharmacies
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An endotoxin test detects toxins that are released from the cell wall of disrupted gram-negative bacteria.
Articles:
- Comparison of Endotoxin Testing Methods for Pharmaceutical Products
- Endotoxin Testing with a Contract Testing Laboratory
- Endotoxin Challenge Vials
- Endotoxin Essentials
- Endotoxin Limits
- The Importance of Endotoxin Testing
- USP <85> Bacterial Endotoxin Validation and Its Importance to the Test Method
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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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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.
Articles:
- Essentials of United States Pharmacopeia Chapter 51 Antimicrobial Effectiveness Testing
- Minor Chapters, Major Impacts – What USP Chapters 51, 61, 62, and 1207 Mean for Your Compounding Practice
- USP <51> Antimicrobial Effectiveness Testing
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These tests quantitate the total population of aerobic bacteria, yeast, and molds in raw materials, in-process samples, and finished products.
Articles:
- Microbial Tests for Non-Sterile Products
- Microbial Limit Tests for Nonsterile Pharmaceuticals Part 1
- Microbial Limit Tests for Nonsterile Pharmaceuticals-Part 2
- Minor Chapters, Major Impacts – What USP Chapters 51, 61, 62, and 1207 Mean for Your Compounding Practice
- USP <61> and USP <62> Microbial Tests for Non-Sterile Products
Webinars
These tests verify the absence of objectionable microorganisms in drug products and raw materials.
Articles:
- Microbial Tests for Non-Sterile Products
- Microbial Limit Tests for Nonsterile Pharmaceuticals Part 1
- Microbial Limit Tests for Nonsterile Pharmaceuticals-Part 2
- Minor Chapters, Major Impacts – What USP Chapters 51, 61, 62, and 1207 Mean for Your Compounding Practice
- USP <61> and USP <62> Microbial Tests for Non-Sterile Products
Webinars
Microbiological Examination of Nonsterile Products – Tests for Burkholderia cepacia Complex USP <60>
This test procedure evaluates the microbiological quality, specifically the presence of species of the genus Burkholderia, in non-sterile substances and preparations. This is important, because Burkholderia is a potentially dangerous pathogen, especially for drugs or raw materials that are intended for inhalation use, and aqueous preparations for oral, oromucosal, cutaneous, or nasal administration.
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Growth Promotion demonstrates that media used in environmental monitoring programs, media fills, or personnel qualification are capable of supporting microorganism growth.
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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.
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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:
- Entry of microorganisms
- Escape of the product dosage form or entry of liquids or solids
- Escape of nitrogen gas or entry of oxygen, water vapor, or air gase
Articles:
- Container Closure Integrity Testing - vacuum decay test method
- Container Closure Integrity Testing - dye ingress test method
- Minor Chapters, Major Impacts – What USP Chapters 51, 61, 62, and 1207 Mean for Your Compounding Practice
ARL Bio Pharma offers a formulation specific, validated nucleic acid amplification PCR method to screen test samples for mycoplasma. In all cases, careful aseptic technique, appropriate laboratory conditions, and a highly trained staff are able to properly interpret the results are required.
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