BioBurden Rapid Analysis Device Sievers Soleil
Shall we make the bio-burden test 45 minutes?
The bio-burden test is one of the important quality control processes to ensure the safety, quality, and compliance of pharmaceuticals. The culture method requires microbial cultivation, which takes about a week to determine results. The bio-burden rapid analysis device Soleil, developed by Sievers, can detect fewer than 10 viable microorganisms in 100 mL with ultra-high purity in under 45 minutes. It has a strong correlation with the culture method, enhancing the safety of pharmaceuticals and the efficiency of the manufacturing process while minimizing risks. In 2023, the PIC/S GMP Annex 1 was implemented, and rapid methods have begun to be adopted as a means of contamination control. This will be useful for the validation of pharmaceutical water/cleaning/process samples/raw materials/final products.
basic information
【Operational Specifications】 Measurement Range: Less than 10 biotics to 10,000 biotics/100mL Sample Type: Discrete grab sample Display Method: Biotics/100mL Calibration Frequency: Typically every 12 months Measurement Time: Less than 45 minutes Sample Flow Rate: 8ml/min 【Analytical Device Specifications】 Output: USB port, Ethernet Display: 14-inch laptop Power Supply: AC 100–240V; 50/60 Hz; 165VA Main Unit Dimensions: 483 (W) × 432 (D) × 432 (H) mm Weight: 18.1kg
Price information
Please contact us.
Delivery Time
Model number/Brand name
Sievers
Applications/Examples of results
- Quality control of pharmaceutical water - Process samples - Cleaning validation - Raw material acceptance testing - Product shipment testing - Microbial evaluation of manufacturing areas
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| Model number | overview |
|---|---|
| SPRD72000-01 | BioVarden Rapid Analysis Device Sievers Soleil |
