CSPC Jushi Biopharma 8,000m³ GMP GSP ISO13485 Automated AS/RS Vaccine Cold Storage EPC Case

Project Overview

This full-automatic AS/RS vaccine cold storage is custom-built for CSPC Jushi Biopharma, a subsidiary of CSPC Pharmaceutical Group and designated domestic COVID-19 vaccine mass production enterprise. The 8,000m³ multi-temperature warehouse strictly complies with GMP, GSP and ISO13485 standards, adopting double-coil continuous defrost technology and full redundant refrigeration system to avoid vaccine efficacy loss caused by temperature fluctuation.

Core Basic Project Information

• Client: CSPC Jushi Biopharma (Vaccine R&D & mass production base)
• Total effective warehouse volume: 8,000 m³ | Total construction cycle: 130 calendar days
• Compliance certification: GMP Appendix Cold Chain, GSP, ISO13485 medical device quality system
• Core stored goods: Finished human vaccines, intermediate biological raw materials, low-temperature ice bag raw materials

Mandatory control standard: All zones temperature fluctuation ≤±0.5℃ (GMP hard requirement for biological products)

Pre-Construction Client Pain Points

1. Original scattered small cold rooms without AS/RS automation, manual forklift handling causes vaccine collision damage, annual scrap loss reaches 9.2%;
2. Traditional single-coil defrost leads temperature jump over 2℃ during maintenance, triggering repeated NMPA inspection rectifications;
3. No dual backup refrigeration & UPS power supply, power outage risks full batch vaccine deactivation;
4. Discrete temperature recording without tamper-proof audit trail, unable to pass international distributor factory audit.

1 GMP Standard Multi-Temperature Zone Layout & Storage Purpose

Four physically isolated independent chambers with separated refrigeration loops, each equipped independent monitoring sensors, complying with vaccine zoning isolation rules (qualified / pending inspection / defective separated):

Functional Chamber	Fixed Temp Range	GMP Temp Deviation Limit	Main Storage Material
Receiving & Delivery Buffer Zone	2℃ ~ 8℃	≤±0.5℃	Finished vaccine incoming & outgoing temporary storage
Intermediate Biologic Buffer Room	-20℃±3℃	≤±0.5℃	Unfinished vaccine intermediates
Ultra-Low Vaccine & Ice Pack Storage	-40℃±3℃	≤±0.5℃	Long-term stock vaccine + cryogenic ice raw material

All zones adopt B1 flame-retardant PU panels with 0.6mm food-grade anti-corrosion coated steel, inner arc sanitary corners for regular disinfection, no dead angle for microbial breeding.
Insulation thickness differentiated by temperature zone:

• 2~8℃ buffer: 100mm PU
• -20℃ intermediate zone: 150mm PU
• -40℃ ultra-low zone: 200mm ultra-thick low thermal conductivity PUR

2 Full Redundant Refrigeration System Configuration

Each temperature zone matches one-main-one-standby compressor unit, all equipment calibrated for 38℃ southern summer peak ambient load:

Equipment Category	Model & Quantity	Matching Zone Design Advantage
Bitzer Medium/High Temp Piston Compressor	2 sets	Receiving 2–8℃ buffer, stable constant temp
Bitzer Multi-Suction Parallel Rack	2 sets	-20℃ intermediate biologic zone, continuous low-load operation
Hanbell Two-Stage Screw Compressor	2 sets	-40℃ ultra-low vaccine zone, reach stable -40℃ low temp
WXRB Evaporative Condenser SL-700/2245	3 sets	Oversized heat dissipation for southern high temperature
LU-VE Arctigo Industrial Air Cooler	24 units	Low wind speed to avoid vaccine package dehydration

Core safety design: Automatic standby unit switching within 10 mins once main machine faults; dual power supply + long-duration UPS to sustain monitoring data recording 72h after blackout.

3 Core Innovation: Dual-Coil Continuous Defrost Technology

Traditional single-coil evaporator must shut down cooling during defrost, resulting 1.5~2℃ temperature fluctuation, irreversible vaccine protein denaturation.
This project adopts independent double-coil separated pipeline design:
1. One coil runs refrigeration while the other executes hot gas defrost synchronously;
2. Warehouse overall temperature fluctuation controlled below ±0.3℃ all year round;
3. Eliminate temperature spike loss, reduce annual refrigeration power consumption by 35% vs conventional single-coil cold storage.

4 AS/RS Automated Warehouse & Intelligent GMP Control Platform

4.1 Robotic Stereoscopic Storage System

Full unmanned stacker crane inbound/outbound, high-density pallet rack layout, 8,000m³ warehouse can store over 12,000 standard vaccine pallets;
Advantages: Cut manual handling damage loss to below 1%, realize FIFO batch automatic traceability, meet GSP batch management requirements.

4.2 PLC Monitoring System Hardware

• Core Controller: Siemens TP Series industrial PLC + 10-inch HMI touch screen

Electrical Supporting: Schneider full set distribution cabinet, calibrated temperature sensors

4.3 GMP Compliance Core Functions

1. Three-tier authority management: Operator / Equipment Engineer / QA Admin, all operation records non-editable audit trail;
2. Multi-channel alarm: Local sound-light + SMS + email real-time push when temp exceeds threshold;
3. Full warehouse temperature mapping periodic automatic test, data storage retention ≥5 years;
4. Mobile APP remote real-time viewing, support audit report one-click export for drug supervision inspection.

5 Complete GMP Validation Deliverable Documents

After full commissioning, hand over four-stage full validation file package mandatory for NMPA audit:
1. DQ Design Qualification: Warehouse layout, refrigeration & automation design review records
2. IQ Installation Qualification: All equipment installation, calibration, material certificate archive
3. OQ Operation Qualification: Full-load temperature distribution, standby unit switching, power outage simulation test
4. PQ Performance Qualification: 72h continuous full-load stable operation verification report
Supporting certification: GSP inspection report, ISO13485 system matching test records.

6 Measurable Post-Operation Client Benefits

The warehouse has run stably for over 1 year after 130-day EPC delivery:
1. Vaccine handling scrap loss reduced from original 9.2% down to less than 0.8% via AS/RS unmanned storage;
2. Dual-coil continuous defrost eliminates temperature spike risk, passed 2 rounds of NMPA routine inspection without rectification;
3. Full inverter redundant system cuts annual refrigeration electricity cost by 35%;
4. Unmanned stereoscopic warehouse reduces daily cold room operation labor by 60%.

7 5 Common Vaccine Cold Storage NMPA Inspection Pitfalls

1. No standby refrigeration unit → Inspection failure risk during equipment breakdown
2. Single-coil defrost causes large temp fluctuation → Vaccine efficacy risk, mandatory rectification
3. Missing tamper-proof temperature audit trail → Cannot pass GSP batch audit
4. No physical isolation for defective & expired vaccines → Cross-contamination hidden danger
5. Thin insulation for -40℃ ultra-low zone → Long-term overload, frequent temperature out of range

8 FAQ For Biopharma Infrastructure & QA Managers

Q1 Why dual-coil defrost is mandatory for vaccine cold storage?

A Single-coil design needs to stop cooling during defrost, temp rises over 2℃ which leads to vaccine protein irreversible inactivation; dual-coil realizes refrigeration & defrost running simultaneously, fluctuation controlled ≤0.3℃ complying GMP.

Q2 What’s the minimum backup power requirement for vaccine warehouse?

A Must equip dual municipal power supply + independent UPS for monitoring system, sustain data recording over 72h during complete power failure.

Q3 How many vaccine pallets can 8,000m³ AS/RS warehouse hold?

Based on standard vaccine transport pallet size, effective storage capacity reaches 12,000+ pallets after deducting AS/RS crane operation passages.

Q4 What validation files need to be reserved for drug supervision inspection?

Complete DQ/IQ/OQ/PQ four-stage verification reports, equipment calibration certificates and 5-year continuous temperature data logs.

Custom Vaccine Automated Cold Storage Inquiry

If you plan to build GMP-compliant AS/RS automatic cold storage for vaccine & biological product manufacturers, provide warehouse volume and storage temperature demand to get free layout drawing & full validation scheme quotation.

Construction & Completion Photos