Tianfeng TF-FZG-150 Industrial-Scale Freeze Dryer
| Brand | Tianfeng |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | Direct Manufacturer |
| Product Category | Domestic |
| Model | TF-FZG-150 |
| Instrument Type | Shelf-Type Production Freeze Dryer |
| Application Scope | Industrial Production |
| Freeze-Drying Area | 148 m² |
| Ultimate Vacuum | ≤ 2.7 Pa |
| Condensate Capacity (24 h) | 2000 kg |
| Cold Trap Temperature | ≤ −65 °C |
| Main Unit Dimensions | 25 × 2.5 × 3.6 m |
Overview
The Tianfeng TF-FZG-150 is an industrial-scale, shelf-type freeze dryer engineered for high-throughput lyophilization of heat-sensitive biologics, pharmaceuticals, functional foods, nutraceuticals, and specialty materials—including enzymes, probiotics, nanomaterial dispersions, and botanical extracts. Based on the fundamental principles of sublimation under controlled low-pressure and cryogenic conditions, this system removes water from frozen product matrices without inducing thermal degradation or structural collapse. The unit operates by freezing material on stainless steel or aluminum shelves, reducing chamber pressure to ≤ 2.7 Pa via a high-efficiency vacuum system, and applying precisely regulated shelf heating (−45 °C to +80 °C) to drive primary drying through ice sublimation. Secondary drying follows to eliminate bound moisture, ensuring residual water content below 1–2 % w/w—critical for long-term stability of protein-based therapeutics and amorphous nanocarriers.
Key Features
- GMP-compliant construction: Chamber and shelves fabricated from electropolished AISI 304 stainless steel with mirror-finish interior surfaces; zero dead-leg design and fully drainable geometry to meet FDA and EU Annex 1 hygiene requirements.
- Integrated chamber–cold trap architecture: Front-chamber/rear-trap layout minimizes footprint while maximizing condensation efficiency; cold trap rated at ≤ −65 °C using high-reliability imported compressors and refrigerants compliant with ISO 8573-1 Class 2 purity standards.
- Modular shelf configuration: Dual-stack arrangement comprising (15+1) × 2 shelves (912 × 54 × 1.8 cm each), with adjustable inter-shelf spacing of 77 mm; optional aluminum extruded or 304 stainless steel shelves—optimized for uniform thermal conductivity and cleanability.
- High-capacity condensation: 2000 kg/24 h water vapor capture capacity via sanitary-grade stainless steel coil condenser; available in monolithic or segmented configurations per client process validation needs.
- Robust control architecture: Omron PLC-based automation integrated with industrial IPC running proprietary HMI software; supports full recipe management, real-time data logging, and remote monitoring via Wi-Fi-enabled secure network interface.
- Dual-mode defrosting: Steam-assisted or immersion-based defrost cycles ensure rapid, residue-free cold trap cleaning between batches—validated for compliance with cGMP cleaning protocols.
Sample Compatibility & Compliance
The TF-FZG-150 accommodates heterogeneous load formats including bulk trays (up to 1.5 metric tons per batch), stoppered vials (via compatible trolleys), and custom containers for nanoemulsions or enzyme-loaded hydrogels. Its design conforms to key international standards: ISO 22000 (food safety), ISO 13485 (medical device QMS), and ASTM F2476–21 (lyophilizer qualification guidelines). All electrical components meet IEC 61000-6-2/6-4 EMC requirements; vacuum system components comply with PED 2014/68/EU. Documentation packages support IQ/OQ/PQ execution and are structured for FDA 21 CFR Part 11-compliant electronic records and signatures when paired with validated software modules.
Software & Data Management
The embedded control system provides full lifecycle data traceability: time-stamped temperature, pressure, shelf heat flux, and condenser load profiles are stored locally on redundant SSD drives and exportable in CSV or ASTM E2500-compliant XML format. Audit trails record all operator actions, parameter changes, and alarm events with immutable timestamps. Optional cloud synchronization enables centralized fleet monitoring across multi-site manufacturing facilities. Software architecture supports user role-based access control (RBAC), electronic signature workflows, and automated report generation aligned with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).
Applications
- Pharmaceutical manufacturing: Lyophilization of monoclonal antibodies, vaccines, and lyo-ready excipient blends requiring strict residual moisture control and cake structure integrity.
- Nanomaterial stabilization: Freeze-drying of liposomal formulations, polymeric nanoparticles, and metal–organic frameworks (MOFs) without aggregation or crystallinity loss.
- Enzyme preservation: Processing of thermolabile biocatalysts (e.g., proteases, oxidoreductases) for diagnostic kits and industrial biotransformation processes.
- Functional food production: Dehydration of probiotic cultures, anthocyanin-rich fruit powders, and pet nutrition supplements retaining bioactivity and sensory attributes.
- Research-scale process transfer: Bridging lab-scale lyophilization data to commercial GMP production via scalable shelf geometry and identical thermal/vacuum boundary conditions.
FAQ
What regulatory documentation is provided with the TF-FZG-150?
Factory acceptance test (FAT) reports, material certifications (EN 10204 3.1), electrical safety certificates (CE, UL pending), and GMP design rationale documents are included. IQ/OQ protocol templates and raw data logs are supplied upon request.
Can shelf temperature uniformity be validated per ASTM E2500?
Yes—shelves are equipped with ≥4 calibrated Pt100 sensors per layer; mapping studies can be conducted using NIST-traceable wireless loggers to demonstrate ΔT ≤ ±1.5 °C across active drying zones.
Is remote troubleshooting supported?
The IPC includes TeamViewer-hosted secure remote access (with client-defined firewall rules); firmware updates and alarm diagnostics are performed without physical intervention.
What customization options exist for cold trap configuration?
Clients may select monolithic or modular coil assemblies, alternative refrigerants (R513A/R134a), and enhanced corrosion protection for aggressive solvents such as tert-butanol or acetonitrile.
How is cleaning validation addressed?
Surface finish Ra ≤ 0.4 µm, sloped drain paths, and CIP-compatible porting allow for repeatable WFI rinse cycles; swab recovery studies and TOC analysis protocols are supported by engineering documentation.
