Hepalink Pharmaceutical Group Co., Ltd.
Location: Shenzhen, China
Project: Shenzhen Hepalink Pingshan New Pre-filled Syringe Manufacturing Facility
Shenzhen Hepalink Pharmaceutical Group Co., Ltd. has been recognized for its project in a next generation manufacturing facility for high viscosity pharmaceutical products, built in Shenzhen, China. The project ‘Shenzhen Hepalink Pingshan New Pre-filled Syringe Manufacturing Facility’ was completed 4 February 2025 covering 297,715 square feet with an annual capacity of 330 million units. It also achieved EU GMP Certification.
This project has six unique features for innovation - novel technology:
- 5G-Enabled Ecosystem: It utilizes a fully sunken 5G multi-access edge computing architecture, achieving network latency of less than 10ms for real-time equipment interconnection and data control.
- Zero-Touch Logistics: Its seamless integration of 5G automated guided vehicles with vaporized hydrogen peroxide transfer chambers is an industry-first—achieving a fully unmanned material flow from the warehouse to Grade A isolators.
- AI Process Intensification: The facility features an all-in-one nest removal and inspection machine, powered by deep learning-based AI, which eliminates glass-to-glass contact and inspects 24,000 units/hour with 100 percent defect detection.
- Digital Twin Synergy: The facility established a digital twin collaborative model between the Pingshan and Nanshan sites, allowing for rapid transfer of technical resources and production recipes.
- Technical Problem-Solving: The project successfully addressed several industry challenges, such as pump seizing for high-viscosity drugs and glass breakage during high-speed inspection.
- Vertical Integration: To overcome extreme land scarcity, the project embedded a 24-meter-high automated stereoscopic warehouse into the facility's core, increasing space utilization by 52 percent compared to traditional layouts.
With these key features, this project is recognized as a lighthouse project, selected for the China Ministry of Industry and Information Technology "2025 5G Factory Directory" for validating the value of 5G in pharmaceutical manufacturing, which can be seen as an industry benchmark. By adding 330 million units of annual capacity, it provides a stable source of critical medication for millions of patients, mitigating global drug shortage risks. And finally, its "zero-touch" design directly contributed to a 100 percent success rate in the first media-fill simulation, setting a new industry standard for sterility assurance.
This project has also showed excellent safety records. During 703 days of construction and operations, it achieved zero lost time injuries through inherently safer design and AI-enabled computer vision for safety monitoring. This project also achieved an 18 percent reduction in unit energy consumption through a building management system-managed water storage cooling system that saves approximately US$560,000 annually in energy costs.
Based on this innovative technology with safety and sustainability achievements, Shenzhen Hepalink Pingshan New Pre-filled Syringe Manufacturing Facility is recognized as the 2026 ISPE FOYA Category Winner for Innovation – Novel Technology.
Supply Partners and Key Participants
Manufacturer/Owner: Shenzhen Hepalink Pharmaceutical Group Co., Ltd.
Engineer/Architect: Tianju Shi Engineering Technology Group Co., Ltd.
Commissioning, Qualifications, and Validation Services: Tianju Shi Engineering Technology Group Co., Ltd.
Construction Manager: Tianju Shi Engineering Technology Group Co., Ltd.
Main/General Contractor: Tianju Shi Engineering Technology Group Co., Ltd.
Piping Subcontractor: Shanghai Austar Pharmaceutical Technology Equipment Co., Ltd.
HVAC Subcontractor: Hangzhou Airkey Technology Co., Ltd.
Automation and Control Supplier: Tianju Shi Engineering Technology Group Co., Ltd.
Major Equipment Supplier or Contractor:
- Shanghai Swisslog Technology Co., Ltd.
- Syntegon Packaging Technology (Hangzhou) Co., Ltd.
Additional Suppliers:
- Shanghai C&S Engineering & Equipment Co.
- Marchesini Group (Shanghai) Trading Co.
- MAQUET (Shanghai) Medical Equipment Co.
- Zhong Xing Li Lian International Trading (Shanghai) Co.