Analizador rápido de carga biológica Sievers Soleil

Enable same-day actions with bioburden results in less than 45 minutes

How effective is your contamination control?

Waiting days for traditional bioburden results leaves you vulnerable to undetected contamination, production delays, and costly shutdowns. Stop reacting to contamination after the damage is done.

Take control with proactive monitoring that protects your production schedule and gives you confidence to act immediately when contamination threatens your operations.

As a validated rapid microbial method (RMM), the Sievers Soleil delivers bioburden results in under 45 minutes with demonstrated correlation to compendial plate counts in ultrapure water.

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Improve decision-making and reduce risks with the Soleil RMM

Application examples with the Sievers Soleil Rapid Bioburden Analyzer:

Water system troubleshooting – quickly identify and resolve contamination events before they impact production
Initial system startup – verify microbial control before validation activities begin
Post-shutdown monitoring – confirm system integrity after maintenance or extended downtime periods
Filter integrity testing - minimize the risk of contamination by assessing filter reliability and effectiveness

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Take immediate action with bioburden results available in under 45 minutes

The Sievers Soleil represents a breakthrough in rapid microbiological methods (RMM), combining a proprietary cocktail of viability dyes with high-throughput flow cytometry to accurately distinguish viable cells from dead cells and particulates in large sample volumes (20-100 mL). This rapid technology delivers total time-to-result (TTR) in under 45 minutes for the first sample, with an even faster turnaround for subsequent testing, empowering you to make critical decisions the same day.

Easily perform bioburden testing with only three pipetting steps requiring less than 5 minutes of hands-on time per sample, while real-time data visualization delivers immediate insights.

Características y beneficios
Especificaciones
Recursos
Preguntas frecuentes

Características y beneficios

Quantitative bioburden data in less than 45 minutes in compliance with 21 CFR Part 11 and data integrity. Near real-time bioburden results improve risk management strategies by transitioning from retrospective to proactive process controls, facilitating same-day actions to minimize production delays and costly operational shutdowns.
Good correlation to colony-forming units (CFUs) with operating range of 0 CFU/100 mL to 10,000 CFU/100 mL without sample dilution in ultrapure water (UPW). Demonstrated alternative method validation and non-inferiority following USP <1223> guidelines with good correlation to compendial results.
Broad detection of viable and stressed microorganisms (bacteria, yeasts and molds), independent of growth conditions. Simultaneous detection of a range of viable microbes without the challenges associated with specific media requirements or slow growth rates.
Microbe enumeration achieves linearity spanning at least 4 orders of magnitude (10 – 10,000 CFU/100 mL) in UPW. Accurately report bioburden results without dilutions or sample retesting due to too numerous to count (TNTC) or spreading colonies.
Portable in-plant microbial testing system. Maximize operational flexibility with versatile bioburden testing capabilities that can be deployed at-line or in the laboratory to align with specific workflow requirements.

Especificaciones

Especificaciones de operación
Rango	<10 bióticos/100 mL - 10,000 bióticos/100 mL
Tipo de muestra	Muestra al azar discreta
Lectura en pantalla	Bióticos/100 mL
Calibración	Normalmente estable durante 12 meses
Tiempo de análisis	< 45 minutos en total hasta obtener el resultado (TTR)
Temperatura de la muestra	35-39 °C (95-102.2 °F)
Temperatura ambiente	17-30°C (63-86 °F)
Presión de la muestra	N/C
Caudal de muestra del instrumento	8 mL/min
Especificaciones del analizador
Salidas	Puerto USB, Ethernet TCP/IP
Pantalla	Pantalla táctil para portátil de 14' (1920x1080)
Energía	100-240 V~, 50-60 Hz, 165 VA
Fusibles	Cantidad 2; T 5A 250 VAC Reemplace con un fusible del mismo tipo y tamaño Tamaño de la entrada del aparato 5x20 mm
Láser (Clase 1)	Longitud de onda: 488 nm Potencia máxima: 135 mW
Dimensiones	Ancho: 48,3 cm (19 pulgadas) Profundidad: 43,2 cm (17 pulgadas) Altura (sin portátil): 43,2 cm (17 pulgadas)
Peso	18,1 kg (40 libras)
Clasificación de la caja	IP30
Certificaciones de seguridad	ETL, CE, UKCA, FCC, CSA 22.2
Ambiente
Humedad relativa máxima	0-85%, sin condensación
Altitud máxima	3,000 m (9,800 pies)
Grado de contaminación	2

Recursos

Preguntas frecuentes

¿Este método ha sido aprobado por los organismos reguladores?

El Soleil es un método alternativo a los compendios, por lo que se recomienda que cada usuario lo valide en su instalación. It is also recommended that each company test the common isolates, found in their facility, on the Soleil.

Is there data I can view to show that Soleil correlates to traditional plate counts?

Yes, there is! You can read our White Paper that shows detailed results for 11 test microorganisms including a range found in USP <61> and USP <62> and common water isolates here.

How many tests can be performed with a Soleil reagent kit?

The Soleil 40-Test Kit (APK 72000-01) contains reagents, bottles, water, and pipette tips to allow you to perform 40 tests, if running 100 mL samples.