Based on the calScreener® platform, calScreener+ Sterility enables rapid, highly sensitive growth-based detection of viable microorganisms via metabolic heat. It provides continuous detection and automated positive/negative results at two temperatures, in alignment with regulatory guidelines.The system is developed in strategic collaborations with leading pharmaceutical and therapy developers to reduce sterility test release times for cell and gene therapies to under three days.
Key Points:
- Detection of most bacteria within <24 h, fungi within <48 h, and slow-growing C. acnes within <60 h, enabling results in under 3 days
- Direct inoculation of products, eliminating filtration and sample-preparation steps
- Growth-based, phenotypic detection of viable microorganisms with sensitivity down to 1 CFU
- Non-destructive measurements and reliable detection even in highly complex sample matrices
- Automated detection, eliminating manual interpretation and reducing the risk of human error.
