China National Biotec Group Lanzhou 30,000 m³ GMP Plasma & Blood Product AS/RS Cold Storage EPC Case

Project Overview

This full turnkey automated cold storage facility was customized for Lanzhou Blood Products Co., Ltd., a core subsidiary of China National Biotec Group (CNBG). The whole warehouse covers a total usable volume of 30,000 m³, divided into 13 independent temperature-controlled functional zones with dedicated AS/RS automated stereoscopic storage systems, fully complying with NMPA GMP, WHO PQ and FDA 21 CFR Part 11 electronic record standards for plasma and blood derivative storage.

Core stored products: Fresh frozen plasma, human albumin, intravenous immunoglobulin (IVIG), prothrombin complex concentrates and biological reagents, all requiring strict long-term low-temperature constant environment without temperature excursion.
Regional design background: Lanzhou belongs to temperate continental climate, with huge day-night temperature difference up to 15℃, summer ambient peak 38℃, winter extreme low -20℃, requiring ultra-thick insulation and full closed vapor barrier anti-condensation system.

1 Zoning Layout & Specialized Temperature & Insulation Standard

The project sets 13 isolated independent chambers with separated refrigeration loops to avoid cross-temperature interference. Each zone matches exclusive PUR insulation thickness, refrigeration unit configuration and storage temperature range based on blood product storage regulatory requirements.

Functional Zone	Core Storage Goods	Fixed Temp Range	PUR Insulation Thickness	Core Refrigeration Matching
Finished Goods AS/RS Cold Room	Packaged albumin, IVIG finished preparations	2–8℃	150mm Super Lift flame-retardant PUR	2 sets HSK7471-90 semi-hermetic screw compressors
Plasma Raw Material AS/RS Freezer	Bulk fresh frozen plasma	-20 ~ -25℃	200mm Super Lift ultra-thick PUR	2 sets HSN8571-125 heavy-duty screw compressors
Outbound Buffer Hall	Temporary loading & unloading finished products	2–8℃	100mm Super Lift PUR	2 sets 4VES-10Y piston compressors
Plasma Sorting Clean Room	Unpacking, inspection & temporary plasma storage	2–8℃	100mm Super Lift PUR	2 sets 6HE-35Y piston compressors
Reagent Constant Temp Room	Biological detection reagents	2–8℃	100mm Super Lift PUR	2 sets 2CES-4 small piston units
Pre-Thawing Room	Plasma gradual temperature recovery	10–15℃	100mm Super Lift PUR	Independent small refrigeration unit
Waste Product Storage Chamber	Expired unqualified biological products	≤8℃	100mm Super Lift PUR	Single backup cooling unit

All partition wall, floor and roof joints adopt full closed-cell PU foam filling to cut off cold bridge, matched double-layer cyanate ester vapor barrier to solve Northwest large temperature difference condensation risk.

2 Zone-by-Zone Refrigeration & Air Cooler Configuration

All refrigeration systems adopt one-main-one-standby redundant design, automatic unit switching within 120 seconds during fault to avoid blood product quality loss caused by temperature out of range.
1. Finished Goods AS/RS Zone
– Host: 2× Shanghai Zhaoxue HSK7471-90 semi-hermetic screw compressors
– Evaporator: 2× Italy Lu-Ve NKI3X8DC2L low-speed uniform air coolers with hot gas defrost
2. Plasma Raw Material Freezing AS/RS Zone
– Host: 2× Shanghai Zhaoxue HSN8571-125 heavy screw compressors for -25℃ low temp stable operation
– Evaporator: 2× Italy Lu-Ve NKI4X8DC3S high-capacity air coolers
3. Outbound Hall & Sorting & Reagent Zones
– Host: Zhejiang Kaidi piston compressors matched by zone load
– Evaporator: Sweden Beijer Ref low-noise anti-frost air coolers, high-density layout in sorting room to eliminate temperature dead zones

3 Full Intelligent SCADA Monitoring & Compliance Control System

The whole platform meets 21 CFR Part 11 electronic record audit trail requirements, core electrical and control configuration:
1. Main Power Distribution System
– Schneider complete power cabinet, independent split metering for each refrigeration loop, overload & phase loss protection
– Dedicated UPS uninterrupted power supply for monitoring system, sustain 72h complete data recording under full power failure
2. Central PLC Control Platform
– Siemens industrial PLC + MCGS touch HMI central operation terminal, independent door-mounted local display for each chamber
– Multi-layer emergency call intercom system inside warehouse for on-site staff safety
3. SCADA Cloud Remote Monitoring Platform
– Real-time full-warehouse temperature mapping, automatic equipment operation status scanning every 10 minutes
– Multi-level escalation alarm: Local sound-light alarm → SMS mobile notification → email official alert
– Tamper-evident permanent data storage (minimum 5 years), complete user access authority classification & electronic signature audit trail
– Remote mobile web & app real-time access, one-click export audit-ready GMP inspection reports

4 Client Background & Pre-Construction Pain Points

Client Profile

Lanzhou Blood Products Co., Ltd., wholly-owned subsidiary of China National Biotec Group, a national key biologic raw material and preparation manufacturer. All production lines pass NMPA GMP and WHO PQ international certification, core products supplied to domestic hospitals and overseas medical distribution markets.

Original Warehouse Pain Points Before EPC Upgrade

1. Dispersed small independent cold rooms without unified automatic management, manual recording cannot meet 21 CFR Part 11 traceability requirements, frequent NMPA inspection rectifications;
2. No AS/RS automatic stereoscopic racking, manual forklift handling leads to low space utilization and risk of plasma bag collision damage;
3. Single refrigeration unit without standby configuration, once equipment failure causes large batches of plasma temperature excursion loss;
4. Simple insulation structure without full vapor barrier, large temperature difference in Lanzhou leads to wall internal condensation, short panel service life and high power consumption.

This 30,000 m³ integrated automated cold storage solved all compliance, efficiency and safety pain points in one-stop EPC delivery.

5 Northwest Exclusive Customized Engineering Optimization (Lanzhou Climate Adaptation)

Aiming at Lanzhou’s large day-night temperature difference, dry windy summer and severe winter low temperature, 4 targeted optimization designs beyond standard biologic cold storage:
1. Ultra-thick 200mm PUR panels for plasma freezing zone + full double-layer vapor barrier on all exterior walls and roof to block outdoor hot & cold air penetration, eliminate condensation;
2. All steel columns, floor slab crossing positions wrapped with thick PU insulation to completely cut off cold bridge heat leakage;
3. Oversized condenser matched for each refrigeration unit to adapt summer 38℃ extreme outdoor temperature, overall power consumption reduced by 22% vs conventional design;
4. Double air curtain buffer doors at all cargo access openings, separate man & goods passages to avoid frequent temperature fluctuation during inbound & outbound operation.

6 Post-Operation Measurable Benefits After Delivery

The warehouse has passed three consecutive NMPA routine inspections without any rectification records, quantifiable operation gains:
1. AS/RS automatic stereoscopic storage improves space utilization by 38%, realizing unmanned automatic inbound, outbound and inventory counting;
2. Full redundant refrigeration + UPS monitoring system eliminates temperature excursion product loss risk, postharvest scrap loss close to zero;
3. Intelligent peak-valley power scheduling reduces annual comprehensive refrigeration electricity expenditure by 22%;
4. Electronic tamper-proof data records fully meet FDA & NMPA audit requirements, save manual recording QA labor cost by 60%.

7 GMP Cold Storage Common Construction & Operation Mistakes

1. Cancel one-main-one-standby refrigeration unit to cut budget → equipment failure triggers batch plasma scrap during inspection;
2. Omit full vapor barrier in Northwest large temperature difference regions → wall condensation, insulation failure, soaring power consumption;
3. Simplify SCADA system without 21 CFR Part 11 audit trail function → direct NMPA inspection non-compliance;
4. No independent UPS for temperature data logger, power outage loses all storage trace records;
5. Ordinary thin insulation panels used for -25℃ plasma freezer → serious cold leakage, unable to stabilize low temperature.

8 FAQ For Biotech & Plasma Enterprise Cold Storage Investors

Q1 What core regulatory standards must plasma cold storage comply with?

A Domestic: NMPA GMP Appendix Cold Chain, GB 50072 cold storage design standard; Export-oriented: WHO PQ, US FDA 21 CFR Part 11 electronic record & Part 606 blood product storage specifications, complete DQ/IQ/OQ/PQ four-stage validation reports must be delivered.

Q2 Why plasma raw material freezer needs 200mm ultra-thick PUR insulation?

A Plasma long-term storage requires stable -20~-25℃ constant temperature. Lanzhou’s summer high external temperature and large day-night temperature difference cause severe heat infiltration; 200mm thick panels plus full vapor barrier can keep temperature fluctuation controlled within ±0.8℃ long-term.

Q3 What complete validation documents will be delivered after project completion?

A Full set four-stage validation materials: D (Design Qualification), IQ (Installation Qualification), OQ (Operation Qualification), PQ (Performance Qualification), including warehouse temperature mapping test, power failure simulation test, door opening temperature recovery test and all equipment calibration certificates.

Q4 What’s the advantage of AS/RS automated stereoscopic warehouse for plasma products?

A Unmanned automatic access reduces manual collision damage risk, high space utilization, full RFID plasma bag information traceability, one-click inventory statistics, fully meet GMP batch management requirements.

Custom Biologic & Plasma Cold Storage EPC Inquiry

If you need GMP, FDA-compliant automated AS/RS cold storage design for blood product, vaccine and biotech enterprises in Northwest China and Central Asia, provide your total required volume, storage product categories and target temperature range, we can offer free layout drawing, full equipment itemized quotation and complete validation scheme quotation.

Construction & Completion Photos