Cell culture isolator is a fully enclosed sterile isolation system, specially designed for cell preparation, passaging, medium exchange, sampling and culture operations of stem cells, immune cells, primary cells, cell therapy products and other cells. It completely physically isolates operators from the cell culture chamber to eliminate microbial contamination introduced by personnel and the environment. Meanwhile, it protects operators from biological risks posed by highly pathogenic cells and virus samples, and meets compliance requirements of GMP, cell therapy laboratories, cell banks and pharmaceutical cell preparation workshops. Application scenarios: CAR-T/NK cell preparation, stem cell expansion, primary cell isolation, cell seed bank establishment, preclinical and clinical batch preparation of cell drugs.

Physical Isolation: The main chamber is a sealed rigid cavity. All experimental operations inside the chamber are performed via operation gloves. Operators’ hands do not come into direct contact with the chamber interior, cutting off contamination sources including human dander, saliva and microorganisms.

Airflow and Pressure Control

Sterile Culture Mode: Positive pressure is maintained inside the chamber to prevent infiltration of contaminants from the external environment.

Biosafety Mode (for high-risk sample handling): Negative pressure is maintained inside the chamber to prevent leakage of internal cells/aerosols and protect operators.

High-efficiency Filtration: HEPA high-efficiency filters (Class H14) are installed for air intake and exhaust, with a filtration efficiency of ≥99.995% for 0.3 μm particles; ULPA ultra-low penetration air filters are optional for some models.

Gas Environment Regulation: CO₂ concentration, temperature and humidity inside the chamber are precisely controlled to simulate the environment of a cell incubator. Long-term cell culture can be carried out directly in the isolation chamber without repeated cell transfer.

Transfer Isolation: Equipped with a laminar flow transfer window / sterile transfer chamber. The entry and exit of materials and consumables will not damage the sterile environment of the main chamber, enabling sterile transfer.

In-situ Sterilization: VHP vaporized hydrogen peroxide is adopted for in-situ sterilization. Automatic aeration and degradation are performed after sterilization with no residues. Repeated cyclic sterilization is available to replace manual wiping disinfection.

Main Isolation Chamber: Integrated chamber for cell manipulation and culture, equipped with built-in culture trays and supports for placing culture flasks, culture bags and bioreactors.

Glove Manipulation Unit: Isolated operation interface with on-line leak detection for glove integrity.

Air Handling Unit: Fans, HEPA filters and pressure sensors.

Culture Environment Module: Temperature control module, CO₂ mixing control module and humidity module.

VHP Sterilization Unit: VHP generator, concentration probe and exhaust deaeration system.

Aseptic Transfer Unit: Transfer chamber / laminar flow transfer window for material transfer into and out of the isolator.

Electric Control and Data Acquisition System: PLC + touch screen, supporting audit trail, historical curves and alarm logs.

Waste Liquid Collection Assembly: Sealed waste liquid bag to prevent aerosol dispersion.