JIHEPU YC-300L Medical Refrigerator for Pharmaceutical Storage

Overview

The JIHEPU YC-300L Medical Refrigerator is a purpose-engineered, CE-compliant cold storage solution designed specifically for the secure, temperature-stable preservation of temperature-sensitive pharmaceuticals, vaccines, biological reagents, and clinical specimens in healthcare and life science environments. Operating within the strictly regulated 2–8°C range—aligned with WHO, USP , and ICH Q5C guidelines for biologics storage—the unit employs forced-air circulation to maintain spatial temperature uniformity (±0.5°C max deviation across load volume) and temporal stability (±0.3°C over 24 h under standard test conditions). Its architecture integrates a high-efficiency hermetic compressor, an all-aluminum blow-through evaporator, and a finned-tube condenser optimized for continuous operation in ambient environments up to 32°C. The cabinet’s structural integrity, corrosion resistance, and thermal performance are validated per ISO 13485:2016 requirements for medical device manufacturing and storage equipment.

Key Features

• Microprocessor-based temperature control system with dual PT1000 sensors (one operational, one redundant backup) ensuring ±0.1°C display resolution and real-time deviation monitoring.
• Forced-air convection system with variable-speed EC fan, enabling rapid temperature recovery (<15 min from 25°C ambient to 5°C setpoint after 60-sec door opening).
• Double-glazed, argon-filled tempered glass door with magnetic gasket seal and integrated mechanical lock—compliant with WHO TRS No. 961 Annex 9 for vaccine cold chain integrity.
• Interior illumination via LED strips with motion-activated activation, minimizing heat load and enhancing sample visibility without compromising thermal stability.
• Removable, powder-coated steel wire shelves with epoxy finish—compatible with common laboratory disinfectants and autoclavable at ≤80°C.
• Comprehensive alarm suite including audible/visual alerts for temperature excursions, door ajar, sensor failure, and power interruption—with non-volatile event logging retained for ≥30 days.

Sample Compatibility & Compliance

The YC-300L accommodates standard pharmaceutical packaging formats—including vials (2–50 mL), syringes, blister packs, and multi-dose containers—without obstruction. Its interior layout supports modular shelving configurations to accommodate both high-volume batch storage and low-frequency access workflows. All materials in direct contact with stored products comply with USP for plastic components and ISO 10993-5 for cytotoxicity. The unit meets EN 61000-6-3 (EMC emissions) and EN 61000-6-2 (immunity), and its design adheres to the mechanical safety provisions of EN 61010-1:2010 for laboratory equipment. As a Class IIa medical device registered with China NMPA (Registration No.: see certificate), it supports GxP-aligned validation protocols—including IQ/OQ/PQ documentation templates—and satisfies audit readiness requirements for GLP, GCP, and GDP environments.

Software & Data Management

While the YC-300L operates as a standalone unit without embedded network connectivity, its analog/digital alarm outputs (dry-contact relay + 4–20 mA signal) enable seamless integration into facility-wide BMS or environmental monitoring systems (e.g., SensiNet, TempTale, or TrackSense Pro). Optional USB data logger modules (sold separately) support CSV export of time-stamped temperature logs with traceable timestamps, meeting FDA 21 CFR Part 11 requirements when paired with validated software platforms. All alarm events—including timestamp, duration, and recovery status—are recorded in non-volatile memory with tamper-evident audit trails, facilitating root-cause analysis during regulatory inspections.

Applications

• Primary storage of vaccines (e.g., mRNA, viral vector, and protein subunit formulations) requiring strict 2–8°C maintenance per CDC Vaccine Storage and Handling Toolkit.
• Short-to-medium term holding of monoclonal antibodies, cytokines, and diagnostic enzyme reagents prior to assay preparation.
• Buffer and media storage in clinical microbiology and molecular diagnostics laboratories.
• Backup refrigeration for pharmacy dispensing areas, blood bank satellite units, and outpatient infusion centers.
• Supporting ISO/IEC 17025-accredited testing labs where documented temperature continuity is required for method validation.

FAQ

Is the YC-300L suitable for storing frozen vaccines or cryopreserved samples?
No. This unit is certified exclusively for 2–8°C refrigerated storage and does not support sub-zero temperatures. For frozen or ultra-low temperature applications, refer to JIHEPU’s -25°C or -86°C series.
Does the unit include built-in data logging capability?
Standard configuration includes local event logging only. Continuous temperature logging requires optional USB data logger hardware and compatible PC software.
What validation support is provided for GxP compliance?
JIHEPU supplies IQ/OQ protocol templates, calibration certificates for factory-installed sensors, and material declarations—all aligned with Annex 15 of the EU GMP Guide and FDA Guidance for Industry on Process Validation.
Can the refrigerator be installed in non-climate-controlled corridors or utility rooms?
Yes, provided ambient temperature remains between 16–32°C and relative humidity does not exceed 80% RH non-condensing, per IEC 60068-2-1/2 environmental testing standards.
What is the expected service life under continuous operation?
Rated for ≥15 years of 24/7 operation when maintained per manufacturer-recommended intervals (condenser cleaning every 6 months; compressor oil inspection annually).