Sievers Soleil Rapid Bioburden Analyzer
Veolia
Microbiology in the pharmaceutical field: Measurement of bacterial load
Ultrapure bioburden equivalent to conventional methods, in less than 45 minutes
Advantages
- 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
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.
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.
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 Temperature1 | 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 (1920×1080) |
Power | 100-240 V~, 50-60 Hz, 165 VA |
Fuses | Qty 2; T 5A 250 VAC Replace with same type and size fuse Size 5×20 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 (40 lb) |
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 |
Brochure
Sievers Soleil Rapid Bioburden Analyzer Brochure (pdf / 170,47 KB)