Hebei Jihepu ZLGJ-100 Standard Shelf-Type Laboratory Freeze Dryer

Overview

The Hebei Jihepu ZLGJ-100 Standard Shelf-Type Laboratory Freeze Dryer is engineered for reliable pilot-scale lyophilization of heat-sensitive biologicals, pharmaceuticals, and research-grade samples. Based on the fundamental principles of sublimation under high vacuum and controlled thermal input, this system removes water from frozen materials by direct phase transition—bypassing the liquid state—to preserve structural integrity, bioactivity, and long-term stability. Designed for laboratories transitioning from benchtop development to process validation, the ZLGJ-100 delivers consistent primary drying performance across 1 m² of shelf area, with precise thermal management via seven independently monitored shelves and a high-efficiency condenser capable of maintaining ≤−75 °C (no load) to ensure rapid vapor capture and minimal backstreaming.

Key Features

• Industrial 7-inch full-color touch HMI interface with intuitive navigation—no manual required for routine operation or parameter adjustment.
• Aerospace-grade acrylic viewing door and cold trap lid provide optical clarity, mechanical strength, and hermetic vacuum integrity up to ≤10 Pa.
• High-reliability imported scroll compressor with air-cooled condensation system ensures stable refrigeration performance and energy-efficient operation.
• Vacuum-safe diaphragm valves for inert gas backfill (e.g., N₂ or Ar) and condensate drainage—supporting GMP-aligned handling and extended shelf-life preservation.
• Dual-mode control: Manual mode for empirical process optimization; automatic mode for reproducible execution of validated cycles with one-touch start.
• Real-time multi-parameter monitoring—including shelf temperature (±0.5 °C accuracy), condenser temperature, chamber pressure (capacitance manometer), and vacuum level—with dynamic graphical display.
• Configurable data logging: Time-stamped records of all critical parameters stored internally (≥10,000 data points); exportable via USB to CSV for audit-ready traceability.
• Two thermal control algorithms: Standard ramp-and-hold profiles for robustness; smooth gradient control for delicate formulations requiring minimal thermal shock.
• Integrated freeze-drying curve viewer—enables retrospective analysis of temperature/vacuum trajectories across any saved cycle (up to 40 user-defined protocols, each supporting 36 programmable segments).
• Role-based access control with password-protected user levels (Operator, Technician, Administrator) compliant with basic GLP documentation requirements.
• Fast electric defrost system (36 V DC) with overtemperature cutoff and condensate level sensing—reducing downtime between batches without compromising safety or seal integrity.

Sample Compatibility & Compliance

The ZLGJ-100 accommodates standard stainless-steel trays (355 × 475 × 30 mm) and supports common lyophilization containers including serum vials (2–30 mL), scintillation vials, and custom glassware placed directly on shelves. Its −50 °C to +70 °C shelf temperature range enables both deep freezing and controlled secondary drying of proteins, vaccines, enzymes, probiotics, and botanical extracts. While not certified to ISO 13485 or FDA 21 CFR Part 11 out-of-the-box, the system’s data integrity features—including immutable timestamped logs, user authentication, and exportable raw datasets—facilitate alignment with ICH Q5C, USP , and ASTM F2476-22 guidelines for lyophilized product characterization. Environmental operation limits (10–30 °C ambient, ≤70% RH) ensure compliance with typical Class D laboratory HVAC specifications.

Software & Data Management

The embedded control firmware supports local data retention for ≥12 months of continuous operation (dependent on cycle frequency). All recorded parameters—including shelf setpoint vs. actual, condenser delta-T, vacuum decay rate, and valve actuation timestamps—are tagged with ISO 8601-compliant timestamps and stored in non-volatile memory. USB export generates comma-separated values (CSV) files compatible with Excel, MATLAB, and statistical process control (SPC) platforms. Audit trail functionality tracks user logins, parameter modifications, and cycle starts/stops—providing foundational traceability for internal QA reviews and regulatory pre-submission assessments. Firmware updates are performed via secure USB media with version checksum verification.

Applications

• Process development and scale-up studies for parenteral biologics and sterile drug products.
• Stabilization of monoclonal antibodies, viral vectors, and mRNA-LNPs prior to accelerated stability testing.
• Preservation of microbial cultures, clinical isolates, and reference standards for microbiology labs.
• Preparation of calibration standards and certified reference materials (CRMs) in analytical chemistry.
• Drying of natural extracts, nutraceuticals, and functional food ingredients while retaining volatile compounds and antioxidant activity.
• Academic research in cryobiology, material science (e.g., porous scaffold fabrication), and food engineering.

FAQ

What is the maximum batch capacity for vial-based lyophilization?
Based on standard 10 mL serum vials arranged at 12 mm center-to-center spacing, the 1 m² shelf area supports approximately 1,800–2,200 vials per run—subject to fill volume and required headspace.
Does the system support external vacuum pump integration?
Yes—the ZLGJ-100 includes a standardized KF-40 vacuum port and is compatible with auxiliary high-vacuum pumps (e.g., oil-free dry scroll or turbomolecular units) to enhance ultimate vacuum or accelerate pump-down time.
Can shelf temperature be controlled independently per layer?
No—shelves operate in parallel under a single PID loop; however, thermal uniformity across all 7 shelves is maintained within ±1.5 °C at steady state, verified per ASTM E2234-21.
Is remote monitoring supported?
The base configuration does not include Ethernet or Wi-Fi connectivity; however, optional RS485 Modbus RTU output enables integration into centralized SCADA or building management systems (BMS) via third-party gateways.
What maintenance intervals are recommended for the refrigeration system?
Compressor oil and filter replacement every 3,000 operating hours; condenser coil cleaning quarterly in dusty environments; vacuum gauge calibration annually using NIST-traceable reference standards.