Scan RDI - Ultra-rapid microbial control of filterable products

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ScanRDI (ChemScan RDI fuera de USA)

 

Con su combinación de velocidad y sensibilidad única, representa una revolución en la detección microbiana. Por primera vez, el recuento célular de hasta 1 célula puede darse en cuestión de minutos para microorganismos viables.  Inclyuendo esporas, células estresadas y organismos fastidiosos.


Analizador a tiempo real ScanRDI para productos filtrables

 

Combinando Rápidez & Sensibilidad!

Ultra-rapido: resultados en 90 min !

Recuento directo de microorganismos

Sensibilidad: hasta 1 célula por muestra!

Precisión: Marca todo microorganismo viable (bacteria, espora bacteruana, levadura, hongos, esporas de hongos)

Ideal for pharmaceutical MICROBIOLOGY

Some ScanRDI rapid microbiology analyzer customers


Aplicaciones : aguas de proceso, porducto no esteril, control ambiental, cryptosporidium giarda, etc.

 

ScanRDI : the unique combination of key performances


• From Sampling to result within minutes
• Sensitivity down to one microbial cell in a sample
• Sensitivity independent from the volume filtered (large volumes can be tested)
• No cell multiplication required
• Direct detection of bacteria, yeast, molds & spores
• Direct cell count removes the need for operator calibration and interpretation
• Linear response from 1 to 105 cells for bacteria and 1 to 104 for yeast & molds
• Non-destructive test protocol permits microscopic confirmation
• Robust and easy to use
• 21 CFR 11 compliant
• Full traceability

 

A quantum leap in microbial detection

Although it offers revolutionary performance, is based on two proven technologies - fluorescent cell labeling and laser scanning, and is also called Solid-Phase Cytometry. On their own each has a contribution to make towards enhanced cell detection, but when integrated together the results are truly dramatic - a quantum leap forward.

 

 

Cell Labeling

All viable microorganisms retained on the membrane are labeled with an advanced reagent system which uses enzymatic cleavage of a non-fluorescent substrate to liberate free fluorochrome into the cytoplasm. Only metabolically active cells (including spores) have the ability to perform this cleavage. Even under conditions of stress - such as the nutrient-depleted conditions of process water or in the presence of growth inhibitors - the cleavage will still occur within viable organisms.

Laser Scanning

Scanning is fully overlapping and any cell present on the filter,
which has been specifically labeled with the Fluorassure®
reagents, will be individually and directly detected. It takes
less than 3 minutes to scan the entire membrane
and display the accurate number of viable cells.                                                                

Data Processing

To ensure only labeled microorganisms are detected and counted, ScanRDI employs proprietary powerful signal discrimination techniques.        

 

Result traceability 

ScanRDI provides total traceability for each analyzed sample, which simplifies compliance with accreditation
and Good Manufacturing Practice. Data output is in the form of a tabulated data sheet, which includes daily
control results and a complete file.

 

 

ScanRDI applications

 

 

 

An Investment with Immediate Return
FDA - Approved technology

• Rapid Environmental Monitoring REM: Water - Air - Surfaces

• Process water
Numerous validation studies in the US and Europe show that provides results equivalent to that of the plate-count method, but in a much shorter time frame. This advantage can be used to very efficiently address important situations such as a) Fast characterization of water systems, b) Surveillance of biofilm formation, c) Water-system trend monitoring.
• TVC Bioburden
• Anti-microbial Effectiveness Testing (AET) has a very large measuring range. For general use, there is a linearity between 1 and 105 cells per membrane for bacteria 1 and 104 for fungi. Thus, the need for multiple dilutions is dramatically reduced, thereby minimizing errors and saving time and money. It also helps develop better quality products and tests many more different formulas.
• OOS / Failure investigations
• Desinfectant efficacy, Immediate Cleaning validation
• In-process sample testing
• Final product release
• Specific tests for: Legionella pneumophila, Cryptosporidium, Giardia
• Beverages (beer, wine)spoilers detection
• Cell cultures processes (scale-up & downstream)
ScanRDI eliminates the delay in acquiring results of in-process sampling and reduce the turnaround time of a contaminated run. allows proactive control procedures and reduction in production cycle times for the scale-up and downstream processes. ScanRDI protocol provides consistent sensitivity even in the presence of up to 106 animal cells.

 

 

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