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.
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【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
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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 |
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Since our establishment in 1967, we have been dedicated to the development and dissemination of water quality measurement devices that anyone can use quickly, easily, and with high precision. In today's world, where the effective use of water, a limited resource, is required alongside environmental conservation, we aim to be a total solution provider that responds to all water environments by utilizing our water quality measurement devices, technology, and services. Furthermore, leveraging the latest technology and years of know-how, we are committed to delivering user-friendly and reliable water quality measurement devices more affordably, quickly, and widely.