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.
- Company：セントラル科学
- Price：Other
