CELL THERAPY ISOLATOR

The isolator encloses the cell therapy manufacturing process within a sealed area, covering reagent preparation, cell pretreatment, culture, centrifugation, microscopy and environmental monitoring.

The workstation consists of a transfer chamber and a processing chamber. The transfer chamber acts as a small isolator and achieves Grade A cleanliness within two minutes of startup. Particle counters and viable air samplers continuously monitor cleanliness. Once Grade A conditions are achieved, the chamber opens and samples and reagents are moved by an electric transfer trolley into the processing chamber. A CO₂ incubator, microscope, centrifuge and cell counter support the full process. SCADA provides monitoring, data acquisition and data management to ensure traceability.

TECHNICAL SPECIFICATIONS

Cleanliness: Grade A (GMP compliant)

Sterility assurance level: SAL ≤ 10⁻⁶

Leak rate: Q/V ≤ 0.5%

Noise: ≤ 65 dB

Illuminance: ≥ 300 lux

Air velocity at openings: ≥ 0.5 m/s

Differential pressure: 0–80 Pa