Abstract
The Growth Direct™ System that automates the incubation and reading of membrane filtration microbial counts on soybean-casein digest, Sabouraud dextrose, and R2A agar differs only from the traditional method in that micro-colonies on the membrane are counted using an advanced imaging system up to 50% earlier in the incubation. Based on the recommendations in USP <1223> Validation of New Microbiological Testing Methods, the system may be implemented in a microbiology laboratory after simple method verification and not a full method validation.
LAY ABSTRACT: The Growth Direct™ System that automates the incubation and reading of microbial counts on membranes on solid agar differs only from the traditional method in that micro-colonies on the membrane are counted using an advanced imaging system up to 50% earlier in the incubation time. Based on the recommendations in USP <1223> Validation of New Microbiological Testing Methods, the system may be implemented in a microbiology laboratory after simple method verification and not a full method validation.
- Automation
- Advanced imaging
- Membrane filtration
- Plate count
- Counting error
- Absorbed and emitted light
- Performance qualification
- Method verification
- © PDA, Inc. 2018
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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