Tianfeng TF-FZG Series Laboratory Freeze Dryer
| Brand | Tianfeng |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | Direct Manufacturer |
| Product Category | Domestic |
| Model | TF-FZG Freeze Dryer |
| Price Range | USD 2,800 – 4,200 (FOB Shanghai) |
| Instrument Type | Standard Shelf-Type Freeze Dryer |
| Application Scope | Research & Development Laboratories, QC/QA Labs, Pilot-Scale Processing |
| Lyophilization Area | 0.315 – 100 m² |
| Ultimate Vacuum | ≤10 Pa |
| Condensate Capacity (24 h) | 3 – 1000 kg/24 h |
| Cold Trap Temperature | −40 °C |
| Main Unit Dimensions | 400 × 550 × 700 mm |
Overview
The Tianfeng TF-FZG Series Laboratory Freeze Dryer is a benchtop-to-pilot-scale lyophilization system engineered for precise, reproducible freeze drying of thermolabile biologicals, pharmaceuticals, nutraceuticals, and food-grade materials. It operates on the principle of sublimation—where frozen water is removed directly from the solid phase to vapor under controlled low-pressure vacuum conditions—without passing through the liquid phase. This preserves structural integrity, enzymatic activity, immunogenicity, and bioavailability of sensitive compounds such as probiotic cultures, herbal extracts, vitamins, peptides, and labile biomolecules. Designed for R&D laboratories and small-batch production environments, the TF-FZG series integrates robust refrigeration architecture with programmable shelf temperature control and real-time vacuum monitoring, ensuring compliance with fundamental lyophilization process requirements defined in ICH Q5C, USP , and ISO 22056 (Lyophilization Process Validation).
Key Features
- Shelf-type configuration with uniform heat transfer across stainless-steel shelves, enabling consistent primary and secondary drying profiles across multiple sample vials, trays, or serum bottles.
- Integrated dual-stage vacuum system with oil-lubricated rotary vane pump and optional cold trap enhancement, achieving stable operating vacuum ≤10 Pa for efficient ice sublimation.
- Cryogenic condenser maintained at −40 °C using a high-efficiency cascade refrigeration circuit; accommodates condensate loads from 3 kg to 1000 kg per 24-hour cycle depending on model variant and chamber volume.
- Programmable controller with multi-step drying protocols—including pre-freezing ramp rate, hold time, shelf temperature ramping, pressure-controlled drying, and end-point detection logic.
- Stainless-steel main chamber and condenser housing compliant with ISO 14644-1 Class 5 cleanroom-compatible surface finish (Ra ≤ 0.8 µm), facilitating GMP-aligned cleaning validation.
- Modular design supports future integration with steam-in-place (SIP) or nitrogen backfill modules for enhanced sterility assurance in regulated environments.
Sample Compatibility & Compliance
The TF-FZG platform accommodates diverse sample formats including microbiological cultures (e.g., lactic acid bacteria, yeast strains), botanical concentrates, fruit/vegetable purees, protein formulations, and diagnostic reagents. Its thermal stability profile and minimal residual moisture (<2% w/w typical) meet specifications outlined in ASTM F2376 (Standard Practice for Lyophilization of Biopharmaceuticals) and Chinese Pharmacopoeia (ChP) Volume IV, General Chapter 0931. All electrical components conform to IEC 61010-1 safety standards; mechanical design follows ASME BPVC Section VIII Div. 1 for pressure boundary integrity. Documentation packages include Factory Acceptance Test (FAT) reports, IQ/OQ templates, and material traceability records aligned with GLP and early-phase GMP expectations.
Software & Data Management
Equipped with embedded PLC-based control firmware supporting configurable data logging (shelf temp, chamber pressure, condenser temp, elapsed time) at user-defined intervals (1–60 sec). Exportable CSV files enable post-processing in MATLAB, JMP, or UNIFI for drying kinetic analysis. Optional Ethernet interface allows remote monitoring via Modbus TCP or OPC UA protocols. Audit trail functionality complies with FDA 21 CFR Part 11 requirements when paired with validated electronic signature modules and role-based access control (RBAC) configurations.
Applications
- Preservation of microbial reference standards and working cell banks in microbiology and vaccine development labs.
- Stabilization of functional food ingredients—such as anthocyanins from berries, polyphenols from green tea, and live probiotics—without thermal degradation.
- Routine lyophilization of analytical standards, calibration materials, and QC reference samples in pharmaceutical quality control laboratories.
- Preparation of porous scaffolds for tissue engineering research using natural polymers (e.g., collagen, chitosan).
- Drying of botanical extracts and traditional Chinese medicine (TCM) preparations while retaining volatile oil composition and antioxidant capacity.
FAQ
What is the maximum allowable load volume for the TF-FZG-100 model?
The TF-FZG-100 variant supports up to 100 m² of total drying area, typically configured as a walk-in chamber with 12–16 shelf levels; exact capacity depends on vial size, fill depth, and container geometry.
Can this system be validated for GMP manufacturing use?
Yes—the TF-FZG series provides full documentation support for IQ/OQ/PQ execution; however, final validation must be performed by the end-user’s qualified personnel per their internal SOPs and regulatory jurisdiction.
Is the condenser temperature adjustable below −40 °C?
No—the standard configuration maintains −40 °C as the minimum cold trap setpoint; lower temperatures require optional cascade or cryogenic condenser upgrades.
Does the system include pressure control during secondary drying?
Yes—programmable pressure modulation via vacuum bleed valve enables controlled desorption kinetics and minimizes collapse risk in amorphous matrices.
What maintenance intervals are recommended for the vacuum pump?
Oil changes every 500 operating hours; filter replacement every 1,000 hours; full pump inspection annually or per manufacturer’s service manual.
