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The GMP Cell Therapy Drug Preparation Station creates a controlled sterile workspace for cell therapy preparation while integrating multiple process steps into one enclosed system.
A typical workflow may include:
Material Transfer → Cell Separation → Extraction / Activation → Expansion → Medium Exchange → Testing → Harvesting → Final Transfer
This helps reduce unnecessary operator exposure and repeated material transfer between separate rooms or open workstations.
Parameter | Specification |
|---|---|
Equipment Type | GMP Cell Therapy Drug Preparation Station |
Working Zone Cleanliness | Localized Grade A |
Installation Environment | Class D or above |
Typical Applications | Cell therapy / CAR-T / Stem cell / ATMP |
Inner Chamber Material | 316L Stainless Steel / PTFE |
Surface Finish | Ra 0.4–0.6 μm |
Bio-Decontamination System | VHPS / H₂O₂ |
Control System | Siemens PLC + IPC |
Monitoring Parameters | Pressure / Temperature / Humidity / Airflow / H₂O₂ concentration |
Suitable for controlled cell preparation processes in clinical and production environments.
Supports closed and localized sterile operations for CAR-T-related workflows.
Suitable for selected stem cell separation, expansion and harvesting operations.
Provides a configurable sterile environment for advanced therapy medicinal product development and manufacturing.
Suitable for pilot-scale and clinical-stage cell therapy preparation.
MAYA can configure the chamber structure, integrated instruments, environmental control and automation functions according to different cell therapy processes.
Available support dimensions include:
Process consultation
Layout and 2D/3D design
Equipment customization
FAT / SAT
Validation support
Installation
Commissioning
Operator training
Technical documentation
Remote troubleshooting
On-site technical service
Spare parts support
Maintenance guidance
System upgrade support