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Isolation & Barrier Systems FG-ISO-CC

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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Fenggu Cell Processing Isolator FG-ISO-CC
Fenggu Cell Processing Isolator FG-ISO-CC
Fenggu Cell Processing Isolator FG-ISO-CC

Overview

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

CleanlinessGrade A / ISO 5, unidirectional airflowDecontaminationVHP dry cycle, ≥6-log reduction (subject to validation), condensation-free
Overall dimensions5500 × 1205 × 2600 mm (customizable)Chamber materialSUS316L
FiltrationHEPA ≥ 99.995% @ 0.3 μmViewing panel15 mm tempered glass
Chamber pressure−20 to 150 Pa (adjustable)Illumination> 500 lux
Decontamination time2.5 hPower supply380 V / 50 Hz
Integrated incubator37 °C ±0.2, CO₂ 5%Medium-exchange rate / Noise5 min/dish / ≤ 65 dB(A)
Incubator count, docking configuration and chamber size are configured to your cell-therapy process. Share your batch size and culture workflow for a tailored configuration.

Applications

Cell & Gene Therapy Manufacturing CAR-T / Cell Culture Processing Closed-System Biologics Processing

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Tell us your cell-therapy process and batch requirements, and our engineers will recommend a configuration.

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Frequently Asked Questions

What is a cell processing isolator for?
It integrates the functional components of a cell-therapy workflow (centrifugation, CO2 incubation and closed material transfer) inside one sealed Grade A environment, so cells never leave a controlled atmosphere between steps.
How is it decontaminated?
With a VHP dry cycle designed for a 6-log, condensation-free reduction; decontamination time is about 2.5 hours.
What are its key specifications?
Grade A / ISO 5 unidirectional airflow, SUS316L chamber, HEPA of 99.995% or better at 0.3 micron, chamber pressure -20 to 150 Pa (adjustable), illumination over 500 lux, 15 mm tempered-glass viewing; overall 5500 x 1205 x 2600 mm (customizable), 380 V / 50 Hz.
Does it include an incubator?
Yes. An integrated incubator at 37 C plus/minus 0.2 with CO2 control is built in, so cells can be incubated without leaving the isolator.
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