Cell And Gene Therapy Isolator

The cell therapy isolator integrates cell culture-related functional components such as centrifuges and CO2 incubators to complete cell culture-related operations in a closed aseptic environment to meet the GMP production requirements of cell products.

Features

• Vertical laminar flow
• Built-in Vaporized Hydrogen Peroxide (VHPS) Generator for thorough decontamination
• Adopts dry VHPS technology to avoid condensation
• Unique concentration dynamiclly control technology to avoid the VHPS concentration is too high or too low
• Pressure control technology to minimize the risk of VHPS penerating in the package
• Temperature control during the decontamination process to minimize the high temperature affecting the cell viability
• Full process equipment integration within grade A / ISO 5 environment
• Special liquid transfer technology for continuous and aseptic filling.
• Real time monitoring the velocity, differential pressure, humidity, temperature.
• The chamber cleanliness is monitored by the air sampler and particle counter
• Movable cell incubator can avoid the cross contamination
• Automatic medium replacement modular can improve the efficiency and low the labor cost
• Modular design which is easily installed in class D background
• Validation service: DQ，IQ，OQ，PQ，VHPS penetration test

Technical Parameters

• Cleanliness Class: ISO5 ClassA
• HEPA Filters：H14, HEPA≥99.995%,@0.3um
• Bio-decontamination time: approx. 2.5  hours,reach 6-log SAL
• illumination: ＞500lux
• Power Supply: 380V 50Hz
• Pressure: 20~80Pa adjustable
• Overall Dimensions (LxWxH):5500mm×1205mm×2600mm（Could be customoized）
• Structure: SUS 316L and 15mm tempered glass
• Incubator temperature: 37℃±0.2
• Temperature resolution: 0.1℃
• Temperature fluctuation:  ±0.2℃
• CO2 concentration: 5%
• Cold storage temperature:  2-8℃
• Rewarming temperature:  37℃
• Medium replacement speed:  5min/dish
• Noise≤65dB（A）