Étude de cas: 48,000Installation de stockage à froid biopharma conforme au MJ GMP pour Sciences de la vie de Hangzhou Yuanda

Emplacement: Qiantang Nouveau district, Hangzhou, Chine
Facility Type: Stockage à froid biopharmaceutique, Medicine Rangement cool, Vaccin & Reagent Storage
Total Volume: 48,000 Cubic Meters (m³)

Project Requirements & Storage Layout

This state-of-the-art facility was designed to meet stringent biopharmaceutical storage requirements, featuring multiple segregated chambers with precise temperature control for diverse materials:
Refrigerated Storage (2~8°C / 36~46°F): Primary storage, Inbound & Outbound Buffer Areas
Freezer Storage (-20° C / -4° F): Bacterial Powder Storage (+ Dedicated 2~8°C Buffer)
Controlled Room Temperature Storage:
Finished Goods Cool Storage (>25° C / >77° F)
Ambient Storage (10~30°C / 50~86°F)
Raw & Auxiliary Material Cool Storage (0~20°C / 32~68°F)
Capsule Storage (10~25°C / 50~77°F)
Solid Reagent Storage (10~30°C / 50~86°F)

Technical Solution Highlights

1.High-Performance Thermal Envelope:
Wall & Roof Panels: 100mm thick PRI Sandwich Panels (Baosteel 0.5mm color steel both sides), B1 Fire Rating.
Floor Insulation: 100mm thick XPS (Extruded Polystyrene), 300KPA compressive strength, B2 Fire Rating.
Ensures exceptional thermal efficiency for stable temperatures and minimized operational costs.

2.Premium Refrigeration System:
Compressors: 2 Sets of German BITZER Screw Compressor Units (60HP each, parallel configuration).
Evaporative Condensers: 2 Units from VANHENG.
Evaporators (Air Coolers): 8 Sets of Italian LU-VE units.
Air Distribution: Fabric Air Dispersion Ducting with Class A Fire Rating.
Features Gaoshuang custom series air coolers known for low noise, long airflow throw, rapid cooling, enhanced defrosting, and superior air circulation ensuring exceptional temperature uniformity (±0.5°C) throughout each chamber.

3.Precision Temperature Control & Monitoring:
Temperature Sensors: High-accuracy sensors from JUMO, METTLER TOLEDO, or equivalent.
Control System: Fully automated, imported temperature control system with:
Automatic temperature/humidity regulation.
Comprehensive alarm systems (SMS/Email).
Data logging and traceability.
Remote monitoring via mobile/client software.
PLC & SCADA: Analog I/O modules and HMI/SCADA software platform from SIEMENS.
Guarantees GMP-compliant environmental control and full data integrity.

4.Validation & Status:
Phase 1: Successfully installed, commissioned, and validated by an independent third party against stringent national pharmaceutical cold storage regulations.
Current Status: Fully operational and in use.

About the Client:
Hangzhou Yuanda Bio-Pharmaceutical Co., Ltd. is an internationally recognized high-tech enterprise specializing in the R&D, production, and commercialization of biopharmaceutical technologies and products. As Zhejiang Province’s pioneering developer and manufacturer of microecological preparations (probiotic pharmaceuticals), the company drives innovation in microbial-based therapeutic solutions.