Cell Processing Isolator
A closed Grade A environment integrating centrifuge and CO₂ incubation functions for cell-therapy manufacturing, with dry VHP decontamination between processes.
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Also referred to as a Cell Culture Isolator, the Fenggu Cell Processing Isolator integrates the functional components of a cell-therapy workflow — centrifugation, CO₂ incubation and closed material transfer — inside a single sealed, Grade A environment, so cells never leave a controlled atmosphere between processing steps. Vertical unidirectional airflow and integrated VHP dry decontamination between batches meet the closed-process, cross-contamination-free requirements of cell-therapy GMP manufacturing.
Temperature control during the VHP cycle and recirculated supply air is designed to limit excessive chamber temperature affecting cell viability. Docking ports allow multiple incubators to be connected and exchanged without breaking containment, and each cell line can be cultured in its own isolated micro-environment to prevent cross-contamination between products.
Key Features
- Integrated centrifuge and CO₂ incubator within a single closed Grade A enclosure
- VHP dry decontamination — rapid concentration ramp-up, no condensation, low residue risk
- Temperature control during the VHP cycle and recirculated supply air is designed to limit excessive chamber temperature affecting cell viability
- On-line particle counting and viable (microbial) air sampling for continuous Grade A monitoring
- Mobile docking-compatible incubators for multi-batch culture and media exchange
- Independent micro-environment per cell line to prevent cross-contamination
- Automated medium-exchange module improves efficiency and lowers labor cost
- Modular design, on-site assembly, installable in a Grade D clean area
- DQ, IQ, OQ, PQ and VHP culture-vessel-penetration confirmation/validation services provided
- Single- or double-sided operation optional per user needs; number of gloves also user-selectable
- Overall dimensions customizable to user requirements
Technical Parameters
| Cleanliness | Grade A / ISO 5, unidirectional airflow | Decontamination | VHP dry cycle, ≥6-log reduction (subject to validation), condensation-free |
|---|---|---|---|
| Overall dimensions | 5500 × 1205 × 2600 mm (customizable) | Chamber material | SUS316L |
| Filtration | HEPA ≥ 99.995% @ 0.3 μm | Viewing panel | 15 mm tempered glass |
| Chamber pressure | −20 to 150 Pa (adjustable) | Illumination | > 500 lux |
| Decontamination time | 2.5 h | Power supply | 380 V / 50 Hz |
| Integrated incubator | 37 °C ±0.2, CO₂ 5% | Medium-exchange rate / Noise | 5 min/dish / ≤ 65 dB(A) |
Applications
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