Research ArticleTechnology/Application
Method Verification Requirements for an Advanced Imaging System for Microbial Plate Count Enumeration
David Jones and Tony Cundell
PDA Journal of Pharmaceutical Science and Technology March 2018, 72 (2) 199-212; DOI: https://doi.org/10.5731/pdajpst.2017.007955
David Jones
Rapid Micro Biosystems Inc., Lowell, Massachusetts and Microbiological Consulting, LLC, Scarsdale, New York 10583, USA
Tony Cundell
Rapid Micro Biosystems Inc., Lowell, Massachusetts and Microbiological Consulting, LLC, Scarsdale, New York 10583, USA

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In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 2
March/April 2018
Method Verification Requirements for an Advanced Imaging System for Microbial Plate Count Enumeration
David Jones, Tony Cundell
PDA Journal of Pharmaceutical Science and Technology Mar 2018, 72 (2) 199-212; DOI: 10.5731/pdajpst.2017.007955
Jump to section
- 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
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