Unipul Biologics - Recombinant Biopharmaceutical Base
EPC General Contracting for Recombinant Protein Production & Cleanroom Engineering
Scale: 10,000 sqm
Project Overview
A Digital Frontier for Innovative Biomacromolecule Manufacturing
Engineering a state-of-the-art R&D and production hub for Class I innovative biological products.
AIPURE delivered the full-scale cleanroom infrastructure for this 10,000 sqm facility in Tianjin. The project features a cutting-edge “Lights-out Factory” model, integrating intelligent robotics and digital systems to achieve unmanned, high-precision manufacturing. Equipped with five 1,500L stainless steel fermenters and dual production lines for vials and cartridges, this base is a pivotal force in China’s self-developed drug industrialization.
Technical Highlights
Lights-out Factory Integration: Seamlessly integrating cleanroom environments with autonomous robotics for 100% unmanned smart manufacturing.
Large-Scale Fermentation Support: Specialized infrastructure for five 1,500L stainless steel fermentation units, optimizing protein drug scaling.
Dual-Line Precision: Simultaneous implementation of high-speed vial and cartridge filling lines within a unified sterile complex.
Advanced Sterility Standards: Core filling zones engineered to Grade A (ISO 5) standards within a Grade B background for maximum drug safety.
Engineering Challenges & Solutions
Sterile Integration for Massive Fermenters: Installing five 1,500L fermenters required absolute airtight sealing at wall penetrations using food-grade silicone components. We designed independent exhaust filtration units to handle heat and moisture without disrupting the cleanroom’s pressure gradients.
Complex Dual-Line Layout & Cross-Contamination Control: To manage the complexity of simultaneous vial and cartridge production, we utilized a modular cleanroom design. Each line operates as an independent unit with dedicated HVAC systems and airlocks, ensuring zero crossover of personnel or material flows.
Strict Process Segregation: The fermentation zone was physically isolated from downstream purification areas. We implemented dedicated logistics paths and buffer zones to maintain the integrity of the recombinant protein production cycle.
High-Standard A-in-B Environmental Control: For sterile filling, we established a rigorous Grade A air distribution logic within a Grade B environment, satisfying the most stringent GMP requirements for biological products.
Construction Content
Recombinant Production Suites: High-standard environments for large-scale fermentation and purification processes.
Sterile Filling Lines: Specialized suites for vial (liquid/powder) and cartridge filling with integrated environmental monitoring.
Digital Infrastructure: Cleanroom-grade housing for automated robotics and smart manufacturing control systems.
M&E Utility Systems: Total EPC of clean utilities, including specialized HVAC for moisture-intensive fermentation zones.
Why This Project Defines AIPURE
“Precision for the unmanned era. Engineering the future of smart biomanufacturing.”
The Unipul Biologics project showcases AIPURE’s mastery in “Digital-Ready Engineering.” It proves our ability to synchronize ultra-clean environments with industrial 4.0 robotics, ensuring that innovation is never limited by infrastructure.
Project Conclusion
The successful delivery of the Unipul Biopharmaceutical Base solidifies AIPURE’s position as a leader in intelligent pharmaceutical EPC. By integrating five 1,500L fermenters and dual sterile lines into a fully automated “Lights-out Factory,” we have provided a scalable “China Solution” for global biotech innovation. We don’t just build cleanrooms; we build the intelligence behind the next generation of medicine.
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Related Service
Cleanroom Consulting
Cleanroom Design
Construction
Product Manufacturing
Commissioning
Operation & Maintain
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