We are proud to announce that the MuScan(TM) software meets 21 CFR part 11 compliancy. The software has a main focus on full digital processing and handling for optimal user friendliness while safeguarding your process and data.
Automated scanning Optical analysis at its edge The patented MuScan(TM) detection device allows for rapid, automated full field scanning of a surface containing fluorescently stained cells. The LED-based MuScan system is highly robust, shock-resistant and has a small footprint. In combination with the dedicated Sieve-ID(TM) test kits the MuScan(TM) allows a fast and sensitive detection of micro-organisms. High quality images are obtained using patented optical scanning regimes with optimal background reduction. The sample plane is set for each individual sample to be analyzed, ensuring accurate in focus scanning of a complete sample within minutes. Each separate image obtained from a sample is stored and accessible for image analysis processing using the dedicated CFR compliant MuScan(TM) GMP software. RAPID A full-field in focus scanning comprising of 280 images just within minutes. LED-BASED Stable low voltage LED light sources with high intensity to obtain best results. ROBUST Just connect and use. Robust in its design for shipment and with frequent use. SMALL FOOTPRINT Requires only a small space on your laboratory work bench; just 15x50cm. High Quality Only the best in an optimal design for highest quality in optical analyses SENSITIVE The smallest fluorescence is measured and discriminated from the background. Optical scanning A fully automated, continuous in focus scanning. Smart three colour scanning. Low voltage The MuScan is powered at the low voltage of 12-24V. Less voltage giving more power. Optimal visualization of fluorescence The MuScan(TM) device allows for detection of many different micro-organisms like bacteria, fungi and yeasts. As each image from the membrane is in focus throughout the whole image field, all microbes retained on the membrane are efficiently detected. Herewith the number of contaminants in the sample is accurately measured, even with higher precision compared to compendial methods. In contrast with other fluorescent microscopes, there is no need for manual focussing throughout the sample. moreover, due to the use of highly condensed beams of light with sharp edged wavelengths, the effect and thus impact of sample bleaching is highly limited. This in combination with storage of each image for subsequent image analysis, provides a major advantage for accurate analysis and quantification of samples. Optical innovations Even though the current MuScan(TM) device is optimal for its current use, we continue to further improve the MuScan(TM) device by introducing more and other features. These developments are always defined based on customer experiences and desires. If you have a specific request or feature you would like to have implemented in your MuScan(TM) system, please let us know. IQ / OQ / PQ The CE-marked MuScan(TM) device, including GMP software, needs to be installed in a laboratory under defined conditions. To ensure proper installation under cGMP guidelines, we offer Installation and Operation Qualification documentation, customized for the MuScan(TM) device at your site. The IQ / OQ can be performed either by the customer, by Innosieve Diagnostics or your local contact. To allow internal validation of the MuScan(TM) and the GMP software in combination with our Sieve-ID(TM) kits, we have prepared a PQ document. This PQ document will allow you to perform initial validation (so-called PQ1) of the MuScan(TM) and kits prior to matrix testing specific for your application (PQ2). For more information about the IQ / OQ / PQ documentation, please contact us.
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The Sieve-ID(TM) diagnostic platform of Innosieve offers a new generation of rapid sample testing. The Sieve-ID(TM) diagnostic tests are easy to use, user friendly and allow rapid and robust analysis with a sensitivity of 1-5 FFU and high accuracy in quantification. The platform has proven to efficiently collect and concentrate low levels of cells from a large volume suspension. Dependent on user demands, the collected cells can be either specifically detected, quantified, tested for cell viability, subjected to nucleic acid extraction or recovered again from the platform. Using the Sieve-ID(TM) diagnostic platform of Innosieve, in most cases a sample can be analyzed directly without the need for time-consuming bacterial enrichments. The complete test can be performed in 1 hour (from sample to result). All Sieve-ID(TM) diagnostic kits are fully compatible with the automated MuScan(TM) device, giving reliable quantitative results within minutes. How are cells visualized? Using the Sieve-ID(TM) kits, microbial cells can be visualized using different approaches: - Generic staining dyes - Selective staining dyes - Fluorescently labelled DNA/RNA/PNA probes - Fluorescently labelled antibodies Due to the generic nature of the Sieve-ID(TM) diagnostics, organisms can be detected using different specific labels or generic cell staining dyes. Even combinations of different labels are possible. Which staining principle to use mainly depends on the custom demands for detection and quantification. At Innosieve we have different diagnostic kits available, ranging from specific detection to generic detection of microbial cells.
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Next Generation RMM - Direct Microbial Analysis In general, Rapid Microbial Methods (RMM) allow users to obtain results more early compared to conventional methods. Most of current RMMs rely on microbial growth to enable earlier detection. The next generation RMM focuses on the direct detection and enumeration of microbes, without limiting sensitivity and specificity. In this ground-breaking field of RMMs the most advanced and powerful method that meets these high demands is the MuScan(TM) technology. The MuScan(TM) technology relies on solid phase cytometry. In combination with our dedicated Sieve-ID(TM) kits a rapid and sensitive direct detection and quantification of microbes in a sample is allowed, even within 1 hour. The MuScan(TM) technology is validated for total viable count analysis according to USP[1223] and performance is non-inferior to the compendial reference method. The MuScan(TM) technology principle relies on 3 steps. Step 1: A fast and efficient sample preparation is performed to provide a reliable analysis. The purpose is mainly to separate the microbes from eventual clogging agents in the sample. Step 2: The sample is processed using our Sieve-ID(TM) protocol based on solid phase cytometry. The microbes are retained on the dedicated membrane, washed and stained for subsequent analysis. Step 3: The membrane with stained microbes is analysed using the automated optical scanning device, the MuScan(TM). The GMP software provides a report presenting the number of found viable microbes.
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Responsive and CFR compliant - Full package Responsive and CFR compliant The MuScan(TM) GMP software has been designed to fully meet CFR compliancy. The GMP software is completely digital, meaning no paper-based documentation and administration is required. Dependent on customer demands, it allows a cyclic or linear double eye data confirmation approach. All data is stored on the customers' server. Full password management and complete logging of all actions is included. The CFR21 part 11 compliant GMP software relies on image analysis of the scans obtained from the MuScan(TM) device. Diagnostic algorithms incorporated in the GMP software ensure accurate detection and quantification of the organisms of interest. Audit trails and training The MuScan(TM) GMP software provides tools for easy searches in audit trails within logged data. All data that is generated needs to be assessed by at least two individuals. Each modification made to the data is logged, avoiding errors in interpretation of the data. The GMP software meets all CFR requirements and upon request also IQ/OQ documentation can be purchased for rapid installation and operational testing of the MuScan(TM) device including the GMP software. To allow an easy start, a dedicated training is available for use of the GMP software, providing all features of the software when used as Operator, Reviewer and Administrator.
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