Class III isolator CST series

for the pharmaceutical industryasepticfor sterility testing

Introduction
Tailin CST series Sterility Test Isolator is designed to protect critical processes such as sterility testing and dispensing. It provides a continuous GMP Grade A environment by means of a physical barrier and an integrated dry vaporized hydrogen peroxide (VH2O2) system, reducing the risk of exogenous and cross-contamination and meeting EU GMP / FDA cGMP / USP-NF requirements. The unit supports continuous or batch operation.


Features

Built-in VH2O2 sterilization system achieving up to 6-log kill sterility assurance level, shortening sterilization cycles.

Vertical unidirectional laminar flow with no dead space to protect critical aseptic operations.

Modular structure for easy disassembly and reassembly, facilitating packing and transport.

Intelligent control system with multi-level user authority, e-signature and audit trail functions, compliant with GMP, EMA and FDA data integrity and computer system validation requirements.

Ergonomic design: optimized tilt angle of the control panel, lighting and working height for operator comfort.

Optional integrated functional modules: environmental monitoring, glove integrity testing, sterile transfer pass box, rapid transfer port (RTP), sterility test pump, sterile liquid transfer port, bag-in/bag-out (BIBO) HEPA filter, etc.

Support for sterilization cycle development, validation studies and related services.

Energy-saving air handling design to reduce room fresh air demand and HVAC load.

Applications
Used for sterility testing or microbial limit testing of sterile pharmaceutical products. Suitable for sterility testing of drug products, aseptic quality control operations, and aseptic testing in R&D and validation environments.


Technical Specifications
Airflow: Unidirectional flow
Noise: <65 dB(A) in 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: 2500 W (aseptic holding stage)
Max. Power: 3000 W (sterilization cycle stage)