Zhongke Duling MPC-5V1105D Medical Refrigerated Storage Cabinet

Overview

The Zhongke Duling MPC-5V1105D Medical Refrigerated Storage Cabinet is an engineered solution for reliable, continuous cold-chain preservation of temperature-sensitive biological materials—including vaccines, blood components, reagents, clinical specimens, and pharmaceuticals—in compliance with WHO, CDC, and national regulatory requirements for 2°C–8°C storage. Designed specifically for high-throughput clinical laboratories, blood banks, central pharmacy departments, and biorepositories, this cabinet employs a dual independent refrigeration architecture—two physically separated compressor-evaporator circuits operating in parallel—to ensure uninterrupted thermal stability. Should one system experience mechanical failure or service interruption, the secondary system maintains setpoint temperature within specification without user intervention, thereby eliminating single-point failure risk. The forced-air cooling system ensures uniform temperature distribution across the entire 1105 L working volume, with validated temperature uniformity ≤ ±0.8°C at steady state (per ISO 14644-1 Class 5 cleanroom-equivalent air circulation design). All internal surfaces are constructed from medical-grade stainless steel (AISI 304), non-porous and corrosion-resistant, facilitating routine disinfection and minimizing microbial retention.

Key Features

• Dual independent refrigeration systems with automatic failover logic and real-time status monitoring
• 7-inch capacitive touchscreen interface supporting multilingual UI (English, Spanish, French, Arabic), password-protected configuration access, and audit-trail-enabled parameter logging
• Fingerprint biometric + RFID card authentication for role-based access control (administrator, technician, operator)
• Light-blocking door assembly with high-density polyurethane foam insulation (≥120 mm thickness) and magnetic gasket seal to minimize radiant heat ingress and UV exposure
• Modular interior layout: three adjustable wire shelves and four full-extension, anti-slip polymer drawers—each labeled with removable alphanumeric ID tags for inventory traceability
• Lockable heavy-duty casters (two fixed, two swivel with brake) enabling safe relocation and stable floor anchoring in ISO-certified laboratory environments
• Comprehensive alarm suite compliant with IEC 61000-4 electromagnetic immunity standards: audible beeper (85 dB @ 1 m), dual-color LED status indicators, and configurable SNMP/SMTP alert forwarding to facility management systems

Sample Compatibility & Compliance

The MPC-5V1105D accommodates standard clinical storage configurations—including 50 mL conical tubes, 15 mL centrifuge tubes, cryovials (2 mL), blood bags (up to 500 mL), vaccine vials (1–10 mL), and multi-well plates—without compromising airflow integrity. Its interior geometry supports both vertical and horizontal orientation of primary containers while maintaining required air exchange rates (≥12 air changes/hour). The unit conforms to GB/T 28039–2011 (Chinese national standard for medical refrigerators), meets essential requirements of EU MDR Annex I (2017/745), and supports validation protocols aligned with USP , ISO 13485:2016, and FDA 21 CFR Part 11 when paired with optional electronic log software. Temperature mapping reports (IQ/OQ/PQ-ready) are supported via integrated USB data export and optional cloud-based calibration certificate archiving.

Software & Data Management

Embedded firmware provides local data logging of temperature (every 2 minutes), door events, alarm triggers, and system diagnostics for ≥30 days. Optional Zhongke Duling CloudLink™ platform enables remote access via secure TLS 1.2 connection, allowing authorized users to review historical trends, download CSV-formatted logs, configure SMS/email notifications, and generate PDF compliance reports. All electronic records include immutable timestamps, user IDs, and digital signatures—fully compatible with GLP/GMP audit requirements. The system supports integration with hospital LIS/HIS infrastructure through HL7 v2.5 or RESTful API endpoints, enabling automated cold-chain event synchronization with specimen tracking workflows.

Applications

• Vaccine storage in national immunization programs and WHO EPI-compliant facilities
• Blood bank inventory management for whole blood, RBCs, platelets (short-term), and plasma derivatives
• Clinical trial material storage under ICH-GCP temperature monitoring mandates
• Pharmaceutical quality control labs requiring 2°C–8°C stability testing chambers
• Biobank core facilities housing human biospecimens under ISO 20387:2018 accreditation frameworks
• Academic research laboratories maintaining primary cell cultures, antibodies, and enzymatic reagents

FAQ

Does the MPC-5V1105D support 21 CFR Part 11-compliant electronic records?
Yes—when used with the optional CloudLink™ software package and configured with user authentication, audit trail logging, and digital signature modules, it fulfills all technical controls required for Part 11 compliance.

What is the mean time between failures (MTBF) for the dual refrigeration system?
Based on accelerated life testing per IEC 60601-1, the combined MTBF exceeds 25,000 hours under continuous operation at 25°C ambient.

Can the unit be validated for IQ/OQ/PQ according to GAMP 5 guidelines?
Yes—the cabinet includes factory-installed calibrated NIST-traceable PT100 sensors (±0.1°C accuracy), pre-defined test points, and documentation templates aligned with GAMP 5 Annex 12 verification practices.

Is remote firmware update capability available?
Firmware updates are delivered via encrypted USB stick or authenticated HTTPS push through CloudLink™; no unsecured OTA updates are permitted.

What power supply specifications are required?
220 V AC ±10%, 50 Hz, 16 A dedicated circuit with surge protection and uninterruptible power supply (UPS) recommended for critical applications.