See how our mobile sterile rooms solve the critical challenges of traditional fixed sterile environments.
Revolutionary container-based solutions serving diverse medical and pharmaceutical applications
Utilizing mobile cleanrooms in new drug development can significantly reduce costs by providing a contained, controlled environment without requiring extensive permanent infrastructure investments.
Implementing mobile cleanrooms in cell manufacturing for biopharma offers a cost-effective solution to meet stringent regulatory requirements, providing a validated and easily maintainable controlled environment.
Mobile cleanrooms guarantee a controlled, particulate-free environment for critical testing and validation assays in biopharmaceutical manufacturing, ensuring data integrity and reliable results.
Comprehensive product parameters designed for optimal performance and reliability
Precision you could see, quality you could feel. Designed to meet the demanding needs of high-precision environments like stem cell therapy.
Optimized design using Computational Fluid Dynamics modeling ensures aseptic conditions.
Precisely adjust temperature, humidity, and pressure to meet your specific needs
Equipment Tailored to Your Specific Requirements
Choose the monitoring and control software that best manages your environment and records your processes.
Our mobile sterile rooms undergo rigorous third-party testing to ensure compliance with international standards. We provide comprehensive lifetime technical support to guarantee your investment's long-term performance.
Our mobile sterile rooms meet the highest international standards for pharmaceutical and medical device manufacturing environments.
Fully compliant with FDA regulations for sterile manufacturing environments and cleanroom standards.
Meets all NMPA requirements for pharmaceutical manufacturing facilities and quality control systems.
Design Qualification, Installation Qualification and Operational Qualification documentation and testing completed for all systems.
Performance Qualification tailored to your specific products. We provide comprehensive testing data and documentation to support your validation process.
Meet our core team of experts who bring together design innovation, construction excellence, and regulatory compliance to deliver superior mobile sterile room solutions.
Engineer Zhao is a renowned biopharmaceutical process engineer with 20+ years in pharmaceutical engineering design. He has delivered 100+ projects, demonstrating comprehensive understanding of GMP, FDA, and related regulations. Expertise includes automated and digitally integrated manufacturing facilities. Notably, he led process design for Fosun Kite's CAR-T production line, China's first. He has deep experience designing laboratory and production processes for antibody drugs, biologics, cell and gene therapies (CAR-T, stem cells), and vaccines.
Engineer Xiao is a distinguished, registered engineer (public utilities, fire safety, consulting) specializing in ventilation and filtration systems for the pharmaceutical and chemical industries. With 20+ years of experience, he excels in HVAC design, leading over 300 projects and earning 20+ provincial/national design awards. As a committee member of prominent engineering associations, Xiao also contributes to national and industry standards. His patents and publications enhance safety and efficiency in specialized ventilation and energy-saving systems for the pharmaceutical and chemical sectors.
Engineer Wang is a Senior CGMP Quality and Consulting Manager, a Registered Consulting Engineer, with 17 years of experience in US FDA CGMP validation and consulting. As a manager of FDA consulting projects, she organizes and coordinates FDA consulting validation activities. She has successfully completed over 20 FDA-CGMP validation projects, 7 GAP risk assessments, 4 FDA on-site inspections and 483 responses, achieving zero observations during one on-site inspection. She has also participated in the development of one group standard.