Analisador rápido de biocarga 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 e benefícios
Especificações
Recursos
Perguntas frequentes

Características e benefícios

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.

Especificações

Especificações operacionais
Faixa	<10 bióticos/100 mL - 10,000 bióticos/100 mL
Tipo de amostra	Amostra aleatória separada
Leitura de exibição	Bióticos/100 mL
Calibragem	Tipicamente estável por 12 meses
Tempo de análises	< 45 minutos de tempo total para o resultado (TTR)
Temperatura da amostra	35-39 °C (95-102,2 °F)
Temperatura ambiente	17-30 °C (63-86 °F)
Pressão da amostra	N/D
Vazão de amostra do instrumento	8 mL/min.
Especificações do analisador
Saídas	Porta USB, ETHERNET, TCP/IP
Tela	Laptop 14 com tela sensível ao toque (1920x1080)
Energia	100-240 V~, 50-60 Hz, 165 VA
Fusíveis	Qtd. 2; T 5A 250 VAC Substitua com o mesmo tipo e tamanho de fusível Entrada do aparelho tamanho 5x20 mm
Laser (Classe 1)	Comprimento de onda: 488 nm Potência máxima: 135 mW
Dimensões	Largura: 48,3 cm (19 pol.) Profundidade: 43,2 cm (17 pol.) Altura (sem laptop): 43,2 cm (17 pol.)
Peso	18,1 kg (40lb)
Classificação do gabinete	IP30
Certificações de segurança	ETL, CE, UKCA, FCC, CSA 22.2
Ambiente
Umidade relativa máxima	0-85%, sem condensação
Altitude máxima	3.000 m (9.800 pés)
Grau de poluição	2

Recursos

Perguntas frequentes

Esse método foi aprovado pelos órgãos reguladores?

O Soleil é um método alternativo ao compêndio, por isso a recomendação é de que que cada usuário o valide em suas instalações. 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.