Mango provides the M6, a fully automated microbial detection system for quality control laboratories. This platform uses advanced imaging and machine learning to deliver sterility and bioburden results in hours, significantly faster than traditional methods. The system integrates seamlessly into regulated workflows, offering accurate colony quantification and 21 CFR Part 11 compliant reporting.
Funding
Funding not disclosed
Founders
Product
Problem
Traditional microbial quality control methods for bioburden testing in manufacturing processes can take days to produce results, leading to potential delays in product release and increased risk of contamination events. Manual colony counting is prone to human error and lacks the data integrity required for regulatory compliance.
Solution
Mango's M6 system offers a rapid bioburden testing solution that delivers results within hours using super-resolution microscopy and automated enumeration. The system combines filtration, incubation, and high-resolution imaging to detect micro-colonies at an early stage, significantly reducing the time required for microbial quality control. By providing real-time contamination alerts and seamless integration with LIMS, the M6 enhances data integrity, minimizes the risk of releasing contaminated batches, and saves QC employees' time. The system's automated, growth-based assay uses standard media and eliminates the need for manual data entry, streamlining validation and ensuring compliance.
Target Audience
The primary target audience includes quality control labs in pharmaceutical, biotechnology, and other manufacturing industries that require rapid and accurate bioburden testing for regulatory compliance and product release.
Features
- Complete filtration, incubation, and enumeration system for rapid bioburden testing
- Super-resolution microscopy enables micron-scale resolution across a wide field of view
- Automated enumeration of bacterial and fungal colonies using machine learning
- Growth-based test with an industry-leading limit of detection
- 21 CFR Part 11 compliant software with complete traceability
- Direct integration with LIMS for enhanced data integrity
- Automated report generation without human intervention
- User-serviceable design with hot-swappable bays for minimal downtime