Shanghai IVEN Pharmatech Engineering Co. Ltd. has successfully completed a modern intravenous (IV) solution pharmaceutical plant for a US Client in the United States, marking a historic milestone as the first pharmaceutical factory in the USA to be completely designed and built by a Chinese pharmaceutical engineering company. This achievement represents a significant step forward for China’s pharmaceutical engineering industry on the global stage.
The project stands as a core example of IVEN Pharmatech’s IV Solution Turnkey Project and Pharmaceutical Manufacturer Integration Project Solution, a comprehensive engineering offering showcased on the company’s official website. The turnkey solution integrates every critical stage of pharmaceutical manufacturing into a unified, highly automated production system designed to meet stringent international standards.
For the U.S. IV solution project, IVEN Pharmatech was responsible for the full scope of design, engineering, manufacturing, installation, and validation. The modern pharmaceutical plant incorporates advanced cleanroom facilities, production machinery, laboratory equipment, and utility systems, all developed in strict compliance with U.S. FDA cGMP requirements. In addition, the project meets USP43 standards and aligns with ISPE, ASME BPE, and other relevant U.S. regulatory standards.The entire system was validated in strict accordance with both US FDA cGMP standards and the GAMP 5 quality management framework, ensuring robust control, reliability, and traceability across all processes.
At the core of the facility is IVEN’s integrated IV solution production line. The IV bag filling line adopts fully automated printing, bag forming, filling, and sealing technologies. Following filling and sealing, an automatic terminal sterilization system is used, where robots handle the automatic loading and unloading of IV bags onto sterilization trays. These trays move automatically in and out of the autoclave, creating a seamless and controlled sterilization process.
Post-sterilization, the IV bags undergo rigorous automated inspection. High-voltage leak detection machines and automatic visual inspection systems are employed to reliably identify leakage, internal particles, and bag defects. This inspection stage is designed to ensure consistent product integrity and quality while minimizing the risk of human error.
The project also features a fully automated end-of-line packaging system. This integrated packaging line includes flow wrapping of IV bags, automatic unfolding of shipping boxes, robotic packing, insertion of certificates and instruction manuals, online weighing with automatic rejection of non-conforming units, box sealing, printing with camera-based inspection, automatic palletizing, and final pallet over-wrapping. The result is a highly efficient packaging process that supports large-scale production with consistent quality control.
From pharmaceutical water treatment to solution preparation and transportation, and through to filling, sterilization, inspection, and final packaging, the entire production process is designed for high automation. This approach significantly reduces labor requirements, lowers contamination risks, improves production efficiency, and supports stable, high-quality output. Automated control and monitoring systems are integrated throughout the facility, ensuring precise management of critical parameters in real time.
This U.S. IV solution turnkey project exemplifies IVEN Pharmatech’s broader Pharmaceutical Manufacturer Integration Project Solution. The company’s turnkey capabilities encompass purification rooms with automated control and monitoring systems, pharmaceutical water processing systems, solution preparation and transfer systems, pharmaceutical filling, sealing, and packing systems, automated logistics systems, and pharmaceutical inspection and control systems. Each element is engineered to function as part of a cohesive whole, delivering efficiency, compliance, and scalability.
With more than 20 years of continuous development, IVEN Pharmatech has completed 40+ pharmaceutical turnkey projects in over 20 countries and has exported thousands of pieces of equipment to more than 60 countries worldwide. The successful delivery of the U.S. IV solution plant further reinforces the company’s experience in executing complex, high-standard pharmaceutical engineering projects across diverse regulatory environments.
Shanghai IVEN Pharmatech Engineering Co. Ltd. continues to operate under its long-standing philosophy of “Create Value for Customers.” By combining advanced technology, rigorous quality systems, and comprehensive project integration, the company remains committed to delivering valuable, reliable pharmaceutical manufacturing solutions to customers around the world.
For more information, connect contact on:
Whatsapp: +86-139 1611 9950
Email: cs@pharmatechcn.com
Website: https://www.ivenpharmatech.com/.
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Company Name: Shanghai IVEN Pharmatech Engineering Co., Ltd
Contact Person: Charlene Liu
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City: Shanghai
Country: China
Website: www.ivenpharmatech.com
