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Sievers Soleil Rapid Bioburden Analyzer

Ultrapure bioburden equivalent to conventional methods, in less than 45 minutes

What if you could get your bioburden results in 45 minutes or less?

When you’re waiting days for bioburden results, there’s a lot at risk. But with rapid microbial testing equivalent to traditional plate counts, you can quickly make decisions and take action – all with confidence.

The Sievers Soleil is a rapid microbial method (RMM) that provides near real-time data to monitor ultrapure water and manufacturing processes, finally providing actionable results that correlate to conventional methods.

Improve decision-making and alleviate risks throughout manufacturing with the Soleil RMM

With the Sievers Soleil Bioburden Analyzer you can rapidly:

  • Monitor critical control points in your water system
  • Test intermediates and in-process samples
  • Confirm cleaning validation / sanitization of equipment
  • Screen incoming raw materials on the receiving dock Perform environmental monitoring of process areas

How would this impact your contamination control strategies? How would this change your operations?

Traditional bioburden testing methods are too slow for effective process monitoring and product release, with plate and membrane filtration methods taking days for results. With the Sievers Soleil Rapid Bioburden Analyzer, you can finally get results in <45 minutes, with data correlating to plate counts. The Soleil is a first of its kind Rapid Microbiological Method (RMM) that uses unique reagents, viability stains, and high throughput flow cytometry to distinguish between viable cells and abiotic particles.

Stop waiting for plate counts! The Sievers Soleil allows you to easily improve your operations, alleviate risk, and remove the bioburden testing bottleneck in product release.

Features & Benefits

  • Obtain near real-time bioburden data that correlates to plate counts
  • Less than 45-minute total time to result (TTR) for the first sample, and even faster for subsequent samples
  • Make fast decisions about the manufacturing process to reduce risk and increase cost savings
  • Release products with confidence and remove the bioburden testing bottleneck
  • Monitor contamination control processes within water systems, cleaning validation, environmental monitoring, raw materials, and in-process samples
  • Reduce costly waste such as discarded product and process inefficiencies
  • Perform testing in the lab or at-line throughout manufacturing (can be easily transported to different locations!)
  • Easily perform testing with only three pipetting steps (operator hands-on time <5 minutes per sample)
  • Simplified, high throughput testing for sample volumes 20-100 mL
  • Detect viable cell counts from Gram-negative bacteria, Gram-positive bacteria, yeast, and mold
  • Distinguish between viable cells and abiotic particles using proprietary fluorescent stains and high-throughput flow cytometry to ensure accuracy and sensitivity
  • Measure not only water, but also complex samples including drug substances, culture media, plastics, and more

Specifications

Operating Specifications?


Range

<10 biotics/100 mL - 10,000 biotics/100 mL

Sample Type?

Discrete grab sample

Display Readout?

Biotics/100 mL

Calibration?

Typically stable for 12 months?
Analysis Time?
< 45 minute Total Time to Result (TTR)

Sample Temperature

35-39 °C (95-102.2 °F)

Ambient Temperature?
17-30°C (63-86 °F)

Sample Pressure?

N/A

Instrument Sample Flow Rate?

8 mL/min?

Analyzer Specifications


Outputs

USB port, Ethernet TCP/IP

Display

14' Laptop touchscreen (1920x1080)

Power?

100-240 V~, 50-60 Hz, 165 VA

Fuses

Qty 2; T 5A 250 VAC

Replace with same type and size fuse?

Size 5x20 mm appliance inlet?


Laser (Class 1)

Wavelength: 488 nm

Max Power: 135 mW

Dimensions Width: 48.3 cm (19 in)
Depth: 43.2 cm (17 in)
Height (without laptop): 43.2 cm (17 in)

Weight

18.1 kg (40lb)
Enclosure Rating

IP30


Safety Certifications?

ETL, CE, UKCA, FCC, CSA 22.2

Environment

Maximum Relative Humidity? 0-85%, non-condensing?
Maximum Altitude? 3,000 m (9,800 ft.)
Pollution Degree 2

Resources

FAQs

Can the Sievers Soleil be used for samples other than purified water?

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Yes, the Sievers Soleil can be used to test raw materials, in-process samples, and products. Some samples may require dilution or other sample preparation prior to testing.

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Has this method been approved by regulatory bodies?

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The Soleil is an alternative method to the compendia, so it is recommended that each user validates it in their facility. It is also recommended that each company test their common isolates that are found in their facility on the Soleil.

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

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Yes there is! You can read our White Paper that shows detailed results for 11 microorganisms .

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