Cellular therapy isolator CGT Isolator

type Aasepticfor clean rooms

Introduction
The Tailin CGT isolator is a fully enclosed, integrated operating system engineered for preparation and handling of cell and gene therapy products under GMP sterile production requirements. It consolidates equipment for cell separation, activation, modification, expansion, observation, collection and dispensing within a continuously controlled aseptic environment.
Features

• Aseptic: maintains a continuous Class A aseptic environment compliant with GMP production for open/process-critical steps.
• Sterilization: integrated dry vaporized hydrogen peroxide (VH2O2) sterilization system validated to achieve 6-log spore reduction.
• Data monitoring:
• Real-time recording of system control and environmental monitoring data.
• Continuous operation video recording for process review and audits.
• Full data traceability for the entire production process.
• Modular design: configurable modules to match process workflows and equipment choices.
• Space saving: compact footprint enabling installation where traditional cleanroom construction is impractical.
• Cost saving: can be installed in Class D buildings, reducing need for extensive B/A room construction and lowering CAPEX/OPEX.
• Extensive options: selection of crucial downstream and monitoring equipment available.

Applications
Complete equipment solution for preparation and quality control of cell therapy products. Typical application areas include:

• Cell therapy manufacturing: support for separation, primary culture, expansion, induction, harvest, cryopreservation and re-infusion workflows.
• GMP sterile laboratories: enables fully enclosed GMP-compliant sterile production, replacing traditional multi-room cleanroom layouts.
• Clinical and research centers: suitable for clinical-scale production and R&D workflows for stem cell and immunotherapy products.

FAQ (selected)

• How does the CGT Isolator ensure internal sterility? It uses VH2O2 (dry vaporized hydrogen peroxide) sterilization validated to reach 6-log spore reduction and maintains a Class A aseptic environment with continuous monitoring and full data traceability to ensure ongoing GMP-compliant sterility control.
• What optional features are available? Options include RTPs, particle counters, air samplers, H2O2 concentration sensors (high/low), portable H2O2 safety sensor, WiFi glove integrity tester (GIT-WLAN) and other custom modules to fit process requirements.