Hainan Tongmeng Pharma — High-Precision Lyophilized Powder Injection Suite
Specialized Cleanroom Engineering for Sterile Injectable Production
Grade A in Grade B Lyophilized Injectable Suite | ISO Class 5 | EU GMP Annex 1 | 1,500 m²
Project Overview
Setting the Standard for High-End Sterile Lyophilization
Engineering a high-precision production environment for non-terminal sterilization injectable powders.
AIPURE delivered a 1,500 sqm specialized cleanroom facility for Hainan General Union Pharmaceutical. The project supports the production of sophisticated anti-tumor lyophilized injections and biological products. By integrating fully automated HVAC and batching systems with ISO 5 (Grade A) laminar flow protection, we ensured a sterile environment that meets the most rigorous pharmaceutical standards for high-value injectable drugs.
Technical Highlights
Grade A in Grade B Aseptic Core: Implementation of ISO 5 (Grade A) laminar flow protection across the entire filling line to ensure the required sterility assurance level.
Dual-System Automation: Full integration of automated Building Management Systems (BMS) for both HVAC and ingredient batching processes.
Precision Environmental Control: Strict regulation of relative humidity (below 55%) and temperature (18–24°C) specifically optimized for moisture-sensitive lyophilized powders.
Intelligent Monitoring: Real-time tracking of pressure gradients, air velocity, and air change rates (ACR) to maintain a consistent GxP-compliant environment.
Engineering Challenges & Solutions
Non-Terminal Sterility Requirements: Lyophilized powders cannot undergo post-filling sterilization, meaning the entire process must be 100% sterile. We engineered a high-integrity cleanroom envelope with superior airtightness and specialized zoning to eliminate any risk of microbial contamination.
Complexity of Dual-System Automation Integration: Synchronizing the HVAC system with the automated batching system required sophisticated technical integration. Our engineering team designed a unified control logic that monitors and adjusts environmental parameters in real-time, ensuring seamless coordination between the facility infrastructure and production equipment.
Precision ISO 5 Laminar Flow Protection: Maintaining a vertical, uniform air pattern in the filling zone is challenging due to the movement of machinery and needles. We utilized advanced airflow modeling to design a laminar flow system that prevents turbulence and vortices, ensuring particle counts stay below 3,520 per m³ (≥0.5μm) even during high-speed operations.
Strict Dehumidification & Thermal Stability: Given the hygroscopic nature of lyophilized products, we deployed specialized HVAC modules to maintain humidity below 55% while ensuring the thermal stability required for sterile dispensing zones.
Construction Content
Sterile Fill-Finish Suites: Grade A/B cleanroom environments designed for high-end lyophilization processes.
Automated MEP Infrastructure: Full installation and commissioning of smart HVAC systems and clean utility piping.
Material Handling & Batching Zones: High-precision ingredient processing areas with integrated dust and microbial control.
Advanced Environmental Monitoring (EMS): Installation of sensors and control loops for centralized facility management.
Why This Project Defines AIPURE
“Mastering the synergy of automation and the required sterility assurance level.”
The Hainan General Union project showcases AIPURE’s expertise in “Intelligent Cleanroom EPC.” By delivering a facility that merges automated system control with high-level laminar flow protection, we demonstrate our ability to provide secure, data-driven infrastructure for the most sensitive pharmaceutical processes.
Project Conclusion
The successful delivery of the General Union Lyophilized Powder Injection Workshop marks a milestone in sterile pharmaceutical engineering. The facility now supports the large-scale production of anti-tumor drugs with 100% GxP compliance. At AIPURE, we don’t just build workshops; we engineer the high-standard foundations that allow pharmaceutical leaders to scale their impact with confidence.
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