Introduction
The cell drug preparation station can guarantee the sterility of the whole process of cell preparation, and realize various operations such as separation and extraction. Combined with the self-developed management system, it is suitable for batch production and clinical trials of cell therapy drugs.
Performance Features
1.Environmental protection: provide class A clean environment for the whole process of cell production and operation, and meet the sterile requirements of GMP.
2.New VHPS technology: integrated vaporized H2O2 biological decontamination system for effective bio-decontamination of operating areas and material channels.
3.Modular design: freely combined multiple functional modules and configurations according to customer needs.
4.Intelligent control system: Siemens PLC+IPC control system; intelligent alarms of pressure, H2O2 solution concentration, temperature and humidity, air speed and other monitoring parameters; the system has multi-level access control; comply with FDA 21 CFR part 11 requirements.
5.Online environmental monitoring: online detection of sterile production environment, which complies with regulatory requirements, with higher sterility assurance.
6.Wireless glove leakage detector: integrated or wireless glove leakage detector is optional.
7.Energy saving and consumption reduction: installed in the environment whose cleanliness is above class D, reducing the construction and operation cost of high-class cleanrooms.
8.Full data record: configured with control system to record key parameter data and ensure traceability.
9.High-quality manufacturing materials: the inner chamber is made of 316L or PTFE, and the chamber polishing grade is 0.4μm~0.6μm.
10.Decomposition filter: the air exhaust module can be equipped with a decomposition filter can effectively shorten the degradation time after H2O2 sterilization, and effectively reduce the concentration level of residues.
11.CDCV service: sterilization cycle development, validation studies and services.
Technical Parameter
| Name | Parameters |
| Material | 316L |
| Polishing grade | 0.4μm~0.6μm |
| Protection level | OEB 5 (OEL<1ug/m³) |
| Internal arc angle | R≥20 |
| Cleanliness level | Class A |
| Power supply | 380V 50Hz (Note: Other voltages require a transformer) |
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