One-Stop GMP & BSL-Compliant Cleanroom Engineering for Advanced Therapy Manufacturing
Our cell and gene therapy cleanroom design service delivers high-standard, biosafety-oriented turnkey engineering tailored for ATMP (Advanced Therapy Medicinal Products) production facilities. We support full-process space planning for cell isolation, viral vector preparation, plasmid manufacturing, cell culture, aseptic filling, quality control laboratories and dedicated material airlock zones, meeting the ultra-rigorous environmental control demands of cell therapy, gene therapy, CAR-T and viral vector production.
We provide full-cycle integrated services including functional area partition design, unidirectional personnel/material flow layout, ISO 5/7/8 classified cleanroom enclosure construction, negative/positive pressure differential isolation, dedicated HVAC air handling systems, single-use equipment pipeline layout, independent waste gas & liquid biohazard treatment, WFI and pure compressed air utility matching, real-time environmental monitoring system deployment, on-site installation, commissioning and GMP qualification validation. All design specifications strictly follow FDA cGMP, EU GMP Annex 1, EMA ATMP guidelines and ISO 14644 cleanroom standards to satisfy global clinical trial and commercial production audit requirements.
Different from traditional pharmaceutical cleanrooms, our design prioritizes strict cross-contamination prevention, independent air change rate control for each functional suite, laminar flow protection for open aseptic manipulation, and complete separation of contaminated and clean zones. Modular cleanroom panel structures enable flexible layout adjustment for pilot labs and large-scale commercial factories. Closed processing airflow design minimizes microbial and particulate risks, while full data traceability systems record temperature, humidity, pressure difference and particle counts round the clock to guarantee consistent production environment stability for sensitive cell and gene materials.
With specialized engineering experience in advanced biotherapy infrastructure, we offer customized schemes for new facility construction, existing lab renovation, and capacity expansion of cell & gene production lines. From initial process consulting, risk assessment and drawing design to final handover and long-term technical after-sales support, we shorten project lead times, reduce compliance risks and help clients pass regulatory inspections smoothly.
Core Advantages
- Professional cleanroom layout exclusively for cell, gene and viral vector therapy manufacturing
- Strict unidirectional flow & pressure isolation design to eliminate cross-contamination
- ISO graded cleanroom construction matching ATMP international regulatory standards
- Complete biosafety waste disposal and real-time environmental monitoring system
- Modular, expandable design for both small pilot labs and commercial production plants
- Full validation documentation support and lifelong technical engineering service
