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Pharmaceutical Technology Cold Storage Project

Shanghai Zhici Medical upgraded its 160m³ pharmaceutical cold storage network, focusing on enhancing reliability of two 20m³ core units to meet stringent global standards for vaccine and biological st

Project Overview

Achieve 99.99% system availability through redundancy design, ensure full-temperature-range compliance (-20°C to 8°C), and realize 100% electronic audit trail.

Start time 2020
Industry Medicine
Project location Shanghai
Total Cold Storage Capacity 160 m³
Temperature Range 2°C–8°C
Humidity Control 35%–75% RH
Sensor Accuracy ±0.1°C,±1.5% RH
Alarm Response Time ≤15 seconds
Control System PLC+SCADA

Challenges Faced

  • Temperature Uniformity

    • Maintaining ±1°C consistency across 160m³ space required breakthroughs in sensor density and control algorithms.

  • Cost-Benefit Balance

    • Full redundancy design increased initial investment by 40%, demanding rigorous ROI justification.

  • Regulatory Harmonization 

    • Reconciling differences in data integrity, alarm prioritization, and calibration cycles across Chinese, European, and U.S. GMP standards.

XNAIR Cold Storage Solution

  1. Hierarchical Control Architecture

    • Deployed "master PLC + zone slave" system with 12 high-density sensor nodes per 20m³ unit, enabling 0.5m-resolution grid monitoring.

  2. Dynamic Redundancy Strategy (动态冗余策略)

    • Implemented N+1 compressor configuration with load-prediction algorithms, reducing backup unit activation time by 60%.

  3. Compliance Mapping Tool (合规映射工具)

    • Developed automated documentation generator aligning with three regulatory frameworks, cutting manual verification work by 70%.

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Project Results and Benefits

  1. Reliability Improvement

    • MTBF increased from 8,000 to 24,000 hours; fault handover time reduced to 8 seconds.

  2. Energy Optimization

    • Annual power consumption reduced by 280,000 kWh through variable-frequency drives and heat recovery, equivalent to 234 tons CO₂ reduction.

  3. Audit Efficiency 

    • 100% electronic records compliance enabled 60% faster FDA inspections and zero-defect EMA remote audits.

Achieved industry-leading 99.99% uptime through hybrid redundancy architecture and AI-driven predictive maintenance.
The 160m³ cold chain network now operates like a Swiss watch. We've eliminated manual data reconciliation and reduced batch release time by 40%. —— Manager

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