Innosieve Diagnostics
Innosieve Diagnostics BV specializes in innovative rapid microbial detection methods, focusing on direct detection and enumeration of microbes without relying on microbial growth. Their flagship MuScan(TM) technology enables rapid, sensitive, and direct microbial analysis within 1 hour, serving industries such as pharmaceutical, industrial, medical, agricultural, and environmental sectors. The company emphasizes validation, cGMP compliance, and software support for their advanced diagnostic platforms, aiming to provide faster, more accurate microbial testing solutions to improve product quality, process monitoring, and environmental safety.
Industries
Nr. of Employees
small (1-50)
Products
Automated fluorescence surface scanner
Bench-top LED-based optical scanner that performs automated, full-field, in-focus multi-color fluorescence scans of membranes or surfaces and stores high-quality images for subsequent software analysis.
Membrane-based diagnostic kits for solid-phase cytometry
Filtration membranes and associated protocols to retain cells/particles from suspension, perform washing and fluorescent staining prior to automated imaging and analysis; optimized for sensitivity down to low particles per sample.
GMP-compliant image analysis laboratory software
Server-based software implementing image analysis workflows, audit trails, role-based approvals and CFR/21 Part 11 controls for validated laboratory use; available in R&D configuration for protocol development.
Rapid microplastics analysis workflow
End-to-end workflow combining sample filtration onto specialized membranes, optimized fluorescent staining for diverse plastic types, automated imaging and software-based counting and sizing down to ~1 µm, with options for downstream spectroscopic confirmation.
Automated fluorescence surface scanner
Bench-top LED-based optical scanner that performs automated, full-field, in-focus multi-color fluorescence scans of membranes or surfaces and stores high-quality images for subsequent software analysis.
Membrane-based diagnostic kits for solid-phase cytometry
Filtration membranes and associated protocols to retain cells/particles from suspension, perform washing and fluorescent staining prior to automated imaging and analysis; optimized for sensitivity down to low particles per sample.
GMP-compliant image analysis laboratory software
Server-based software implementing image analysis workflows, audit trails, role-based approvals and CFR/21 Part 11 controls for validated laboratory use; available in R&D configuration for protocol development.
Rapid microplastics analysis workflow
End-to-end workflow combining sample filtration onto specialized membranes, optimized fluorescent staining for diverse plastic types, automated imaging and software-based counting and sizing down to ~1 µm, with options for downstream spectroscopic confirmation.
Services
Preventive maintenance and calibration
Annual preventive maintenance and on-site hardware testing including LED tests, focus and field position checks, movement verification and fluorescence calibration; deliverable: Preventive Maintenance Report.
Assay support and training
Remote and on-site specialist assistance for membrane-based assay troubleshooting, protocol optimization and hands-on training for assay execution and instrument operation.
Software support and customization
Support services for GMP-compliant image analysis software and R&D software packages, including troubleshooting, configuration and custom image analysis protocol development.
Validation and qualification services (IQ/OQ/PQ)
Provision of IQ/OQ/PQ documentation and services to support cGMP installation and validation of imaging systems and associated assays, including PQ documents for matrix-specific validation.
Leasing option for imaging systems
Equipment leasing model to provide access to automated fluorescence scanning systems under a low monthly cost structure.
Preventive maintenance and calibration
Annual preventive maintenance and on-site hardware testing including LED tests, focus and field position checks, movement verification and fluorescence calibration; deliverable: Preventive Maintenance Report.
Assay support and training
Remote and on-site specialist assistance for membrane-based assay troubleshooting, protocol optimization and hands-on training for assay execution and instrument operation.
Software support and customization
Support services for GMP-compliant image analysis software and R&D software packages, including troubleshooting, configuration and custom image analysis protocol development.
Validation and qualification services (IQ/OQ/PQ)
Provision of IQ/OQ/PQ documentation and services to support cGMP installation and validation of imaging systems and associated assays, including PQ documents for matrix-specific validation.
Leasing option for imaging systems
Equipment leasing model to provide access to automated fluorescence scanning systems under a low monthly cost structure.
Expertise Areas
- Rapid microbial methods for bioburden and environmental monitoring
- Membrane-based solid-phase cytometry workflows
- Fluorescence imaging and automated image analysis
- GMP-compliant laboratory software and 21 CFR Part 11 implementations
Key Technologies
- Solid-phase cytometry (membrane retention and analysis)
- LED-based multi-color fluorescence optical scanning
- Automated image analysis and diagnostic algorithms
- Fluorescent staining (generic dyes, labeled probes, antibodies)