Tianfeng TF-FZG-30 Industrial-Scale Freeze Dryer
| Brand | Tianfeng |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | Direct Manufacturer |
| Product Category | Domestic |
| Model | TF-FZG-30 Flat-Shelf Type |
| Instrument Type | Standard Shelf-Type Freeze Dryer |
| Application Scope | Production-Scale |
| Lyophilization Area | 30 m² |
| Ultimate Vacuum | ≤2.7 Pa |
| Condensate Capacity (24 h) | 600 kg |
| Cold Trap Temperature | ≤−45 °C |
| Unit Dimensions (L×W×H) | 7000×2500×3600 mm |
Overview
The Tianfeng TF-FZG-30 Industrial-Scale Freeze Dryer is a GMP-compliant, production-grade lyophilization system engineered for consistent, scalable freeze-drying of heat-sensitive biological and pharmaceutical materials—including fungal biomass, tea polyphenol extracts, and functional nanomaterials—under controlled low-temperature and high-vacuum conditions. It operates on the fundamental principle of sublimation: frozen water is removed directly from the solid phase to vapor under vacuum, bypassing the liquid phase to preserve structural integrity, bioactivity, and chemical stability. Designed for continuous batch processing in pilot or small-to-medium-scale manufacturing environments, the TF-FZG-30 integrates a cylindrical stainless-steel drying chamber with an integrated cold trap (front-chamber/rear-trap configuration), enabling efficient ice capture and minimizing cross-contamination risk. Its thermal and vacuum performance—achieving ≤2.7 Pa ultimate vacuum and cold trap temperatures down to −70 °C—meets the thermodynamic requirements for primary drying of formulations with low eutectic points and high residual moisture sensitivity.
Key Features
- GMP-aligned construction: Drying chamber and shelf surfaces fabricated from electropolished SUS 304 stainless steel (Ra ≤ 0.4 μm), fully weld-seam polished, zero dead-leg design, compliant with ASME BPE and EU Annex 1 hygiene principles.
- Integrated cold trap with high-efficiency stainless-steel coil condenser, rated for 600 kg/24 h ice capacity; available in monolithic or modular configurations per user specification.
- Flat-shelf architecture with (13 + 1) × 2 shelves (including upper radiant compensation shelf); shelf dimensions: 2140 × 541 × 18 mm; inter-shelf spacing: 77 mm; total active lyo area: 30.1 m².
- High-reliability refrigeration system utilizing premium imported compressors and refrigerant circuits, delivering rapid cooldown (<90 min from ambient to −45 °C) and stable shelf temperature control (±0.5 °C uniformity).
- Dual-mode control architecture: Omron PLC (CP1E-N60DT-D) paired with industrial touch-screen PC running proprietary TFD-5000 software; supports full recipe management, real-time parameter logging, and audit-ready event history.
- Process flexibility: Supports both immersion and steam-assisted defrosting; manual/auto mode switching; on-the-fly step modification and jump-to-step functionality during drying cycles.
Sample Compatibility & Compliance
The TF-FZG-30 accommodates diverse sample formats including bulk trays (standard 540 × 720 mm), stainless-steel trolleys (1 unit included), and custom-fit containers for fungal mycelia cakes, concentrated botanical extracts (e.g., green tea polyphenol solutions), and colloidal nanosuspensions. Its chamber geometry and shelf thermal uniformity ensure reproducible drying kinetics across heterogeneous loads. The system conforms to ISO 9001:2015 quality management standards and incorporates design elements aligned with FDA 21 CFR Part 11 (electronic records/signatures readiness), EU GMP Annex 15 (Qualification & Validation), and ICH Q5C (stability of biotechnological/biological products). All wetted surfaces meet USP material compatibility criteria for pharmaceutical use.
Software & Data Management
The TFD-5000 control software provides a validated, Windows-based interface supporting multi-user role-based access, password-protected parameter editing, and automated generation of electronic batch records (EBRs). Data acquisition includes real-time monitoring of shelf temperature (PT100 sensors, ±0.2 °C accuracy), chamber pressure (capacitance manometer, 0.001–1000 Pa range), condenser temperature, and vacuum pump status. All process data—including alarms, operator actions, and timestamped setpoint changes—are stored locally with optional network backup. Software updates are provided free of charge throughout hardware support life. Audit trails comply with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) for GLP/GMP-regulated environments.
Applications
- Stabilization of thermolabile fungal metabolites (e.g., cordycepin, ganoderic acids) without degradation or polymorphic transition.
- Production-scale lyophilization of standardized tea polyphenol powders for nutraceutical and functional food applications—preserving catechin epimerization ratios and antioxidant capacity.
- Drying of aqueous nanosuspensions (e.g., curcumin, quercetin nanoparticles) with cryoprotectant optimization to prevent aggregation and maintain colloidal stability post-reconstitution.
- GMP-compliant processing of herbal extracts, probiotic cultures, enzyme preparations, and diagnostic reagent kits requiring long-term ambient storage stability.
- Pilot-line validation for scale-up from laboratory (e.g., 0.1–1 m²) to commercial (≥30 m²) freeze-drying operations.
FAQ
Is the TF-FZG-30 suitable for sterile pharmaceutical manufacturing?
Yes—when equipped with HEPA-filtered nitrogen backfill, SIP-capable chamber seals, and validated cleaning-in-place (CIP) protocols, it meets core requirements for Category C/D cleanroom integration per ISO 14644-1.
Can shelf temperature be independently controlled per layer?
No—the system employs uniform shelf heating/cooling via fluid-circulated plates; however, radiant compensation shelves mitigate edge effects and improve axial temperature homogeneity.
What vacuum pump options are available?
Standard configuration includes ULVAC (formerly Unisem) oil-lubricated rotary vane pumps; optional dry screw or hybrid turbo-molecular pump trains are available for solvent-laden or oxygen-sensitive processes.
Does the system support IQ/OQ/PQ documentation packages?
Yes—Tianfeng provides vendor-executed IQ/OQ templates aligned with ASTM F2971-14 and ISO 20514:2021; PQ execution requires site-specific load mapping and cycle development.
What is the typical power and cooling water requirement?
Total electrical load: 125 kW (380 V, 50 Hz, 3-phase, 5-wire); cooling water demand: 40 m³/hr at ≤25 °C inlet temperature and 1.5–2.0 bar pressure.
