EnglishEnglish
As cell therapy is gaining ground worldwide, more and more difficult diseases are looking to this advanced technol - ogy, including the COVID-19. At the same time, sterile isolators from traditional pharmaceuticals have penetrated
into the cell therapy field, and isolators dedicated to the production of cell drugs have appeared, becoming the new favorite of cell therapy.
The so-called cell therapy isolato r is a fully enclosed area for the production of cell therapy drugs, including reagent preparation, cell pretreatment operations, cell culture centrifugation, cell microscopy, and environmental monitoring.
| Quantity: | |
|---|---|
| Reagent preparation | Cell pretreatment operation | Cell culture centrifugation | Cell microscopy | Environmental monitoring | ||||
The Cell-Therapy Isolator is a specialized sterile containment system engineered for cell therapy research, manufacturing, and clinical applications. Integrating HEPA H14 filtration, VHP (Vaporized Hydrogen Peroxide) sterilization, and real-time environmental monitoring, it maintains ISO Class 5 (Class 100) internal cleanliness to prevent cross-contamination of sensitive cell lines. Constructed with 316L stainless steel (electropolished interior) and equipped with ergonomic glove ports, it supports aseptic operations like cell isolation, expansion, and cryopreservation. Compliant with FDA 21 CFR Part 11 and EMA guidelines, it’s an essential tool for regenerative medicine labs and cell therapy manufacturers.
For CAR-T or stem cell production, the isolator creates a closed sterile environment that eliminates airborne contaminants, ensuring cell viability and product safety. Its integrated gas control system (O₂/CO₂ regulation) maintains optimal culture conditions, while the pass-through chamber enables sterile material transfer—aligning with GMP requirements for cell-based medicinal products (CBMPs).
In university or hospital research labs studying cell biology, the isolator protects valuable cell cultures from external pollutants. The built-in UV-C pre-sterilization function and HEPA-filtered air circulation preserve experimental integrity, supporting studies on immunotherapy and tissue engineering.
For facilities preparing cell therapy products for clinical trials, the isolator’s data logging system (temperature, humidity, pressure) provides traceable records for regulatory audits. Its compact design fits in restricted lab spaces, while customizable internal configurations accommodate different workflow needs.
Dual sterilization: VHP (≥6-log reduction for spores) + UV-C pre-treatment ensures 99.9999% sterility.
ISO Class 5 cleanliness maintained via 200m³/h HEPA H14 filtration and positive pressure control (15-30Pa).
316L electropolished stainless steel interior resists corrosion and simplifies decontamination.
FDA 21 CFR Part 11 compliant touchscreen: monitors parameters and stores 2-year data logs.
Customizable glove ports (4-6 ports) and internal fixtures (bioreactor holders, pipette racks).
We offer end-to-end support for cell therapy workflows: on-site installation with DOP/PAO integrity testing, validation documentation (IQ/OQ/PQ protocols), and operator training on sterilization cycles. Customization includes chamber size adjustment (1200-2000mm length) and integration with bioreactors or cryogenic freezers. Our team provides annual maintenance (filter replacement, leak testing) and 24/7 technical troubleshooting, plus regulatory consultation for CBMP approval.
A1: For daily use, a 60-minute VHP cycle is recommended before operation. Full deep sterilization (120 minutes) is advised weekly or after handling high-risk cell lines. The system alerts users when sterilization is due via the touchscreen.
A2: Yes. We offer custom adapter plates for integrating automated pipettors, incubators, or cell counters. Our engineers will design the interface based on your equipment’s dimensions and power requirements.
A3: Standard documentation includes CE/FDA certificates, material safety data sheets (MSDS), DOP test reports, and IQ/OQ/PQ templates. We can also assist in preparing process validation reports for regulatory submissions.
 | |||
| Economical: Meet Class D cleanroom installation conditions, with reduced maintenance running costs, no specific con- sumables and no highly trained professionals. | Stable: The cell production environ- ment is easy to control and monitor, enjoying stable working area conditions, homoge-neous and synchro-nized cell growth,rapid quality control and GMP certification of cell products. | Safe: Adopts intelligent and modular design, free from the troubles of traditional clean- rooms; the work area is always a Class A clean environment positive protection; the environ-mental conditions canbe monitored and traced in real time. | Fast: Reduce sample processing time, deliv- ery time and quality control time, and auto- matically implement H2O2 fumigation to simplify the sterilization process. |
