HjClean Aseptic Isolator for Cell Preparation Empowers the Entire Process of Clinical-Grade Cell Therapy Manufacturing

With the rapid development of the cell therapy industry, products such as CAR-T, stem cells and immune cells face stringent challenges in terms of sterility assurance, cross-contamination prevention and process traceability during manufacturing. SUZHOU HJCLEAN TECH CO., Ltd. has long been engaged in the field of sterile isolation equipment and launched a sterile isolator for cell preparation. It creates a closed Grade A operating environment specially for clinical-grade cell isolation, transfection, expansion, medium exchange, sampling, collection and formulation preparation. Compliant with the Guidelines for the Quality Management of Cell Therapy Products and GMP regulations, it builds a reliable sterile barrier for cell drug research and development, clinical sample preparation and commercial production.

The sterile isolator for cell preparation from HjClean adopts an integrated closed chamber structure and is equipped with an in-situ biological decontamination system using vaporized hydrogen peroxide (VHP), together with intelligent temperature control and catalytic residue removal modules. It delivers precise control over the sterilization process to prevent condensation from damaging cell consumables, and rapidly decomposes hydrogen peroxide residues after sterilization to preserve cell viability. The equipment incorporates an automatic air tightness leak detection system; the sterilization process can only be initiated when the chamber passes the tightness test. Fitted with multi-door interlocks and an on-line glove integrity monitoring mechanism, it effectively avoids contamination risks caused by misoperation and prevents cross-contamination between samples of different batches.

The chamber features an optimized vertical unidirectional flow design to maintain a continuous ISO 5 (Grade A) clean environment, achieving complete physical isolation between operators and cell samples and eliminating particulate and microbial contamination hazards introduced by human operation on traditional open workstations. The inner surfaces of the chamber are polished to reduce microbial attachment and hiding sites. Microscopes, small centrifuges, sample transfer ports, online particle and airborne bacteria monitoring modules can be integrated as required to accommodate multi-step operations of cell processes. Supported by a high-performance HMI human-machine interaction system and GAMP5-compliant software, it collects critical process parameters including temperature, humidity, pressure differential, VHP concentration, particles and microorganisms in real time, automatically saves operation logs and sterilization curves, supports audit trails and meets data integrity requirements. Full IQ/OQ/PQ validation services are available.

The equipment adopts a modular and flexible design that supports multi-chamber combinations. It can interface with CO₂ incubators, closed material transfer systems and cryopreservation transfer units to realize closed transfer of cell samples. The complete unit can be deployed in a Grade D background cleanroom, greatly cutting the construction and operation costs of cell preparation centers. The product flexibly adapts to multiple scenarios: lab-scale process exploration for new drug development, clinical cell preparation in medical institutions, pilot testing and small-scale commercial production for cell therapy enterprises, covering the preparation of various biological products including immune cells, stem cells and gene therapy vectors.

As a domestic enterprise independently developing and manufacturing clean isolation equipment, Hj Clean holds a number of patents related to isolators and provides one-stop services including scheme design, complete machine manufacturing, on-site installation and commissioning, and validation support. Thanks to its stable closed isolation performance, mild and controllable VHP sterilization process and comprehensive compliance packages, the sterile isolator for cell therapy helps cell therapy enterprises reduce sterility risks and ensure batch consistency. In the future, Hj Clean will continue to iterate sterile isolation technologies and launch more customized clean equipment solutions for the cell and gene therapy industry, facilitating the translation and commercialization of innovative achievements in the biomedical sector.