Tianfeng TF-FZG-100 Industrial-Scale Shelf-Type Freeze Dryer

Overview

The Tianfeng TF-FZG-100 is an industrial-scale, in-situ pre-freezing shelf-type freeze dryer engineered for reproducible, scalable lyophilization of heat-sensitive biological and botanical materials. It operates on the fundamental principle of sublimation—removing water from frozen samples under deep vacuum while maintaining product integrity through precise thermal control. Unlike batch-style or manifold freeze dryers, the TF-FZG-100 integrates primary freezing and secondary drying within a single, sealed chamber, eliminating manual transfer and minimizing contamination risk. Its 10 m² total shelf area supports high-throughput processing of bulk herbal extracts (e.g., Lycium barbarum juice, Glycyrrhiza uralensis concentrate), functional food matrices, and pharmaceutical intermediates. The system employs silicone oil as the heat transfer medium across all shelves—ensuring uniform temperature distribution (±1 °C shelf-to-shelf deviation) and enabling both controlled freezing and programmed drying ramps. With a condenser operating at ≤ −65 °C and ultimate vacuum capability of 2.7 Pa, it achieves low-residual moisture levels (<2% w/w) essential for long-term stability of active compounds in traditional Chinese medicine (TCM) formulations and biologics.

Key Features

• In-situ pre-freezing architecture eliminates sample handling between freezing and drying stages, reducing cross-contamination and process variability.
• Eight stainless steel shelves (7 working + 1 bottom shelf), each 900 mm wide × 1600 mm deep, spaced at 65 mm intervals for optimal vapor flow and tray compatibility.
• Silicone oil circulation system enables precise shelf temperature control from −45 °C to +70 °C, supporting slow nucleation, annealing, and desorption phases.
• PLC-based control system with 10.4″ color touchscreen HMI provides intuitive recipe management, real-time parameter monitoring (shelf temp, chamber pressure, condenser temp), and alarm logging.
• Integrated data acquisition supports continuous recording of temperature and pressure profiles; exportable CSV files comply with 21 CFR Part 11 audit trail requirements when paired with validated software.
• Modular design fits within a standard 20-foot shipping container; footprint (6 × 1.5 × 2.5 m) allows installation in dedicated production rooms meeting ISO Class 7/8 cleanroom prerequisites.

Sample Compatibility & Compliance

The TF-FZG-100 is validated for processing aqueous-based matrices including fruit juices, herbal decoctions, enzyme solutions, vaccine suspensions, and sterile-filtered TCM extracts. Its large condenser (200 kg/24 h capture capacity) accommodates high-moisture loads typical of botanical concentrates. The system meets mechanical and electrical safety standards per GB/T 19001–2016 (ISO 9001 equivalent) and complies with CE machinery directive 2006/42/EC. While not intrinsically certified for FDA GMP manufacturing, its architecture—stainless steel 316L contact surfaces, traceable calibration ports, and configurable validation protocols—supports IQ/OQ/PQ execution per ASTM F2698 and USP . It is routinely deployed in facilities producing dietary supplements compliant with NSF/ANSI 173 and health food registration dossiers under China’s NMPA regulations.

Software & Data Management

Data integrity is maintained via embedded non-volatile memory storing up to 100 complete cycle logs. The system supports Ethernet TCP/IP communication for remote supervision using industry-standard SCADA platforms (e.g., Ignition, Siemens Desigo). Optional Tianfeng LyoView™ software enables multi-parameter curve overlay, deviation analysis against master curves, and electronic signature functionality aligned with ALCOA+ principles. All critical events—including door interlock status, vacuum pump shutdown, and power interruption—are timestamped and archived with user ID attribution. Raw data files are stored in uneditable binary format with SHA-256 hash verification to satisfy regulatory expectations for raw data retention.

Applications

This freeze dryer serves validated applications across regulated and non-regulated sectors: stabilization of polysaccharide-rich goji berry juice for nutraceutical powder production; lyophilization of glycyrrhizin-enriched licorice extract without Maillard degradation; pilot-scale drying of probiotic cultures in synbiotic formulations; and preparation of sterile botanical reference standards for HPLC quantification. In academic research, it supports cryo-structural studies of plant-derived enzymes and preservation of field-collected medicinal root samples prior to metabolomic profiling. Its scalability bridges lab-scale discovery (e.g., vial-based lyophilization on benchtop units) to commercial batch production—making it suitable for technology transfer in contract development and manufacturing organizations (CDMOs) serving TCM modernization initiatives.

FAQ

What is the maximum batch load for herbal extract solutions?
Typical loading is 200 L of 10–15% w/v aqueous extract across eight shelves, yielding ~100 kg of dried powder per cycle.
Can the system be validated for GMP manufacturing?
Yes—documentation packages (URS, FAT/SAT protocols, calibration records) and IQ/OQ templates are available upon request; PQ execution requires site-specific qualification.
Is silicone oil leakage a maintenance concern?
No—the closed-loop circulation system uses welded stainless steel piping and double-sealed rotary unions rated for >10,000 hours MTBF.
Does the unit support nitrogen backfilling for oxygen-sensitive products?
Optional integrated N₂ purge module (0.1–0.5 bar adjustable) is available with pressure-controlled inlet valve and residual O₂ monitoring port.
What cooling infrastructure is required?
A dedicated closed-loop chiller delivering 18 m³/h at 7–12 °C is mandatory; integration with facility glycol systems is supported via plate heat exchanger.