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- Published online March 23, 2018.
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- previous version (December 14, 2017 - 17:10).
- You are viewing the most recent version of this article.
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© PDA, Inc. 2018
Author Information
- David Jones and
- Tony Cundell*
- Rapid Micro Biosystems Inc., Lowell, Massachusetts and Microbiological Consulting, LLC, Scarsdale, New York 10583, USA
- ↵* Corresponding Author: Microbiological Consulting, LLC, Scarsdale, New York, USA; e-mail: tonycundell@gmail.com
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- Article
- Abstract
- Introduction
- Historic Background to the Development of the Plate Count Method
- Plate Count Method Limitations
- Technical Background of the Advanced Imaging System Used in the Growth Direct™ System
- General Description of the Growth Direct™ System
- Universality of Blue Light Excitation and Green Light Emission for the Detection of Micro-colonies
- Selection of Media and Membrane Filters for Microbial Enumeration for Bioburden Determination and Environmental Monitoring
- Advantages of the Growth DirectTM System over the Plate Count
- Regulatory and Compendial Guidance for the Validation of Alternative Microbiological Test Methods
- Review of the Validation Parameters and Their Appropriateness for the Growth DirectTM System
- Recommendations for the Method Verification of the Growth Direct™ System
- Errors Associated with Colony Counting Procedures
- Method Suitability Tests
- Conclusions
- Conflict of Interest Declaration
- References
- Figures & Data
- References
- Info & Metrics