Tailin CST series Sterility Test Isolator is mainly used for the protection of key processes such as sterility testing, dispensing, etc. It create a continuous GMP Grade A environment through physical barrier and efficient VH2O2, reducing the risk of exogenous and cross contamination, and conforming to the EU GMP/FDA cGMP/USP-NF requirements. Continuous or batch operation is possible.
| Airflow: Unidirectional flow | Noise: <65dB(A) when in the aseptic holding stage |
| Built-in Sterility Test Pump: 1 or 2 units | Power Supply: 380V,50Hz |
| Accessories: 12.1" industrial panel PC/NetSCADA system | Power: 2500W when in the aseptic holding stage |
| Max.Power: 3000W when in the sterilization cycle stage |
Used for sterility test or microbial limit test of sterile drugs.
Tailin R&D team has introduced eight major innovations to enhance performance and usability:
It adopts an innovative vaporization structure and advanced control logic, improving vaporization efficiency and hydrogen peroxide saturation control
The system precisely controls condensation to ensure equipment and sample safety.
Using Computational Fluid Dynamics (CFD) analysis, the airflow distribution inside the isolator has been redesigned for optimal performance. A dead-space-free vertical laminar flow ensures continuous Grade A protection for all critical aseptic operations.
Yes. Tailin offers comprehensive VH2O2 sterilization process development and validation services, including: Biological indicator D-value studies, Temperature and humidity distribution analysis, Worst-case point and condition studies, Aeration efficiency testing.
Tailin has also developed VH2O2 biological indicator evaluation resistometer, which simulates isolator sterilization conditions for D-value determination.
The isolator features an optimized air handling system that reduces the requirement for cleanroom fresh air and air conditioning load.
For rooms with limited fresh air supply, an internal catalytic decomposition module is available to break down hydrogen peroxide within the isolator, enabling closed-loop operation without external exhaust.
