The Pharmaceutical Refrigerated Container is a GMP/GDP-compliant modular
cold storage solution engineered for pharmaceuticals, vaccines, and
biologics. Its dual-zone temperature control (-30°C to 8°C) with
real-time monitoring ensures compliance throughout the supply chain.
Selling Points:
Dual-Zone Control: Independent regulation of refrigerated (2°C–8°C) and frozen (-20°C to -30°C) compartments.
Data Integrity: FDA 21 CFR Part 11-compliant electronic records with audit trail capabilities.
Emergency Power: 4-hour UPS backup with seamless generator integration.
Material Safety: 316L medical-grade stainless steel interior for chemical resistance.
Advantages:
WHO PQS certified, meeting EU GDP guidelines and China GSP standards.
Triple-gasket door system limits temperature fluctuation to ±1°C (recovery within 3 minutes).
Tilt sensor activates alarms if inclination exceeds 30° during transit.
Modular flooring enables direct forklift access, optimizing warehouse workflows.
"Consult our cold chain experts now for a customized validation package (DQ/IQ/OQ/PQ)!"
Refrigeration System: Dual-circuit cascade compressors with R290/CO2 eco-friendly refrigerants.
Zone Configuration: Separate refrigerated (2°C–8°C) and frozen (-20°C to -30°C) compartments.
Monitoring System: 7" touchscreen with USB data export and remote cloud access.
Dehumidification: Molecular sieve technology for ≤60% RH control (adjustable).
Lighting: Explosion-proof LED tubes with zone-specific switches.
Alarms: Audible/visual alerts + SMS notifications, multi-level access control.
Exterior: Pre-coated galvanized steel with UV-resistant coating (10-year colorfastness).
Certifications: WHO PQS, EU GDP, ISO 13485, FDA 21 CFR Part 11.
Installation:
Ensure ground flatness within ±3mm/m and install anti-vibration pads.
Use laser alignment tools to maintain partition perpendicularity ≤0.1°.
Connect to a three-phase five-wire power supply with ground resistance <1Ω.
Complete refrigeration system self-test and temperature mapping via the touchscreen (24-hour no-load run required).
Maintenance:
Daily: Inspect door gasket frosting and log temperature/humidity trends.
Weekly: Clean condenser fins using reverse compressed air blow-out.
Monthly: Calibrate sensor accuracy by comparing master display with standalone loggers.
Annually: Replace drier filters and verify refrigerant charge (requires professional equipment).
Accessories:
Shelving: GSP-certified stainless steel slanted beam racks (500kg/layer capacity).
Data Logger: Multi-channel USB thermo-hygrometer with PDF/CSV export.
Emergency Kit: Spare battery, door gaskets, and silica gel desiccant (1-year supply).
Customization:
Zone Expansion: Add ultra-low temperature (-80°C) compartment for mRNA vaccines.
Explosion-Proof: ATEX Zone 2 certification for ethanol/isopropanol storage.
Branding: Corporate color baking paint with laser-engraved GMP compliance labels.
Smart Upgrade: IoT module integration for GPS tracking and door-opening video capture.
Validation: Full DQ/IQ/OQ/PQ documentation package with risk assessment reports.
Spare Parts: 8 global warehouses ensuring core component delivery within 72 hours.
Expertise: Compliance team led by former FDA inspectors offering 48-hour response.
Training: GMP cold chain certification courses with practical assessments and certifications.
"From validation to maintenance, we offer lifecycle compliance support.
Your cold chain compliance officer gains direct access to our technical
experts, ensuring audit readiness at all times."
