Zhengchuan Yongcheng — Automated Prefillable Syringe (PFS) Production Base
Full-Scale Mechanical, Electrical & Aseptic Cleanroom Installation
Standard: ISO 13485 / Class III Device
Project Overview
Setting New Standards in Prefillable Syringe Manufacturing: The Zhengchuan Yongcheng PFS Facility
Engineering a high-performance, automated cleanroom environment for the production of sterile prefillable syringes and advanced pharmaceutical packaging.
AIPURE served as the specialist engineering contractor for the Zhengchuan Yongcheng Prefillable Syringe (PFS) production workshop. As a key investment by Zhengchuan Pharmaceutical Packaging (a leader in the Chinese medicinal glass industry), this facility was designed to meet the surging global demand for vaccine and biological drug delivery systems. Our mission involved the complete installation of high-standard cleanroom envelopes and precision Mechanical & Electrical (M&E) systems capable of supporting fully automated washing, siliconization, and sterilization lines. This project provides the essential infrastructure for a facility dedicated to the highest levels of product integrity and patient safety.
Technical Highlights
Ultra-Clean Aseptic Environment: Engineered specialized Grade A (Class 100) and Grade B (ISO Class 7) zones to support the critical glass forming, washing, and siliconization processes, ensuring zero particulate contamination.
Complex Media Support for PFS Lines: Integrated deployment of high-purity water (WFI), oil-free compressed air, and specialized vacuum systems required for high-speed automated prefillable syringe production.
Precision Airflow & Micro-Particle Control: Implementation of advanced HEPA filtration and laminar flow patterns to manage the delicate balance between thermal loads from glass processing and the need for a dust-free environment.
Automated HVAC & Environmental Monitoring: Deployment of a centralized DDC system to monitor and adjust pressure differentials, temperature, and humidity in real-time, ensuring continuous compliance with ISO 13485 standards.
ESD-Safe Cleanroom Infrastructure: Utilization of specialized anti-static wall panels and flooring to prevent electrostatic discharge, protecting sensitive automated sensors and glass handling robotics.
Construction Content
Automated Washing & Siliconization Suites: Precision-engineered cleanrooms for the critical washing and siliconization stages, featuring high-capacity exhaust systems for moisture and heat removal.
Glass Forming & Processing Workshops: Specialized industrial cleanroom environments designed to house large-scale, high-temperature glass syringe forming machinery.
Sterile Packaging & Nesting Zones: Ultra-clean environments for the final assembly, nesting, and sterile packaging of prefillable components.
Comprehensive M&E Utility Hub: Total installation of power distribution, process cooling water, and high-purity gas piping networks across the entire facility footprint.
Cleanroom Validation & Commissioning: Full execution of IQ/OQ/PQ validation protocols to ensure the facility meets NMPA and international regulatory requirements for Class III medical devices.
Project Conclusion
“A Benchmark for Excellence in High-End Medical Packaging Infrastructure.”
The Zhengchuan Yongcheng PFS project stands as a definitive testament to AIPURE’s ability to bridge the gap between heavy industrial processing and pharmaceutical-grade cleanliness. Managing the integration of high-speed automation with the strict environmental controls needed for prefillable syringes requires a deep understanding of both mechanical engineering and aseptic logic.
By delivering a facility that harmonizes massive utility requirements with microscopic environmental precision, we have provided Zhengchuan with a robust manufacturing engine that fully complies with modern GxP and ISO standards. This achievement reinforces AIPURE’s position as the partner of choice for pharmaceutical packaging leaders who require an engineering firm capable of delivering the highest levels of technical integrity and operational reliability.
For AIPURE, this project represents a proud milestone in our commitment to supporting the global healthcare supply chain through engineering excellence and manufacturing precision.
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