Tianfeng TF-FD-1L Multi-Manifold Lyophilizer (Stoppering Type)
| Brand | Tianfeng |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | OEM Manufacturer |
| Region Category | Domestic (China) |
| Model | TF-FD-1L (Multi-Manifold Stoppering Type) |
| Instrument Type | Multi-Manifold Freeze Dryer |
| Application Scope | Laboratory Use |
| Lyophilization Area | 0.07 m² |
| Ultimate Vacuum | <15 Pa (at no-load) |
| Condensate Capacity | 3 kg/24 h |
| Cold Trap Temperature | <−80 °C |
| Main Unit Dimensions | 600 × 600 × 900 mm |
| Power Supply | 220 V, 50 Hz |
| Power Consumption | 1600 W |
| Sample Shelf | Φ180 mm × 3 layers |
| Compatible Vials | 50, 100, 250, 500, 1000 mL (up to 8 positions) |
| Refrigeration System | Dual-Stage Cascade Compressor |
| Cooling Method | Air-Cooled |
| Display | LED digital readout for cold trap temperature and chamber vacuum |
| Chamber | Transparent bell-jar design with stainless steel sample manifold and adjustable stainless steel shelf |
| Compliance | Designed for GLP-compliant laboratory environments |
Overview
The Tianfeng TF-FD-1L Multi-Manifold Lyophilizer (Stoppering Type) is a vertically oriented, laboratory-scale freeze drying system engineered for high-fidelity preservation of thermolabile and volatile compounds. It operates on the principle of sublimation under deep vacuum: samples are first frozen solid at ≤−80 °C in the integrated cold trap or pre-frozen externally, then subjected to primary drying (ice sublimation) and secondary drying (desorption of bound water) under controlled vacuum (<15 Pa at no-load). This process preserves structural integrity, bioactivity, and chemical stability—critical for sensitive biologicals such as probiotics, cosmetic actives, monoclonal antibodies, enzymes, and botanical extracts. Unlike conventional thermal drying methods, lyophilization avoids phase transitions above freezing, eliminating shrinkage, denaturation, oxidation, and volatile loss. The TF-FD-1L’s dual-stage cascade refrigeration architecture enables stable cold trap operation below −80 °C, significantly enhancing capture efficiency for low-boiling-point solvents (e.g., ethanol, acetone, ethyl acetate), making it suitable for formulations containing organic co-solvents common in cosmeceutical and pharmaceutical R&D.
Key Features
- Multi-manifold configuration with eight independent stoppered ports for simultaneous lyophilization of heterogeneous samples in diverse container formats—including serum vials, scintillation vials, and standard lyophilization flasks (50–1000 mL).
- Stoppering-compatible design allows in-chamber vacuum sealing post-drying, ensuring sterility and moisture barrier integrity without exposure to ambient atmosphere.
- Dual-stage cascade refrigeration system delivers sustained cold trap temperatures <−80 °C, enabling efficient condensation of water and organic vapors with high trapping fidelity.
- Air-cooled condenser eliminates dependency on external cooling water, reducing infrastructure requirements and operational complexity in standard laboratory settings.
- LED digital display provides real-time monitoring of cold trap temperature and chamber pressure—both critical process parameters for method development and reproducibility.
- Stainless steel sample manifold and adjustable three-tier shelf (Φ180 mm per tier) support flexible loading configurations and ease of cleaning per GMP hygiene standards.
- Transparent bell-jar chamber facilitates visual process monitoring while maintaining vacuum integrity and operator safety.
- Standardized ISO-KF vacuum fittings ensure leak-tight connections, rapid disassembly, and compatibility with auxiliary vacuum pumps and gauges from major international suppliers.
Sample Compatibility & Compliance
The TF-FD-1L accommodates a broad spectrum of sample matrices relevant to regulated research and development workflows: aqueous protein solutions, bacterial suspensions (e.g., Lactobacillus, Bifidobacterium), cosmetic emulsions, herbal extracts, vaccine candidates, and diagnostic reagents. Its validated vacuum performance (<15 Pa no-load) and cold trap efficiency meet baseline requirements for ASTM F2375-04 (Standard Practice for Validation of Freeze Drying Processes) and align with ICH Q5C stability testing guidelines. While the base unit does not include automated process recording, its analog signal outputs and RS485 interface support integration with third-party data acquisition systems compliant with FDA 21 CFR Part 11 for audit-trail-enabled electronic records. The stainless steel construction (AISI 304) conforms to ISO 14644-1 Class 7 cleanroom compatibility when installed in controlled environments.
Software & Data Management
The TF-FD-1L operates via intuitive tactile soft-key controls for manual parameter setting (vacuum setpoint, drying duration, shelf positioning). For advanced process control, optional PC-based software (sold separately) enables full-cycle logging of cold trap temperature, chamber pressure, and elapsed time—with timestamped CSV export. When deployed with validated software modules, the system supports electronic signature functionality, user access levels, and change-control logs required under GLP and GMP frameworks. All firmware adheres to IEC 62304 Class B medical device software standards for reliability and traceability.
Applications
- Probiotic Stabilization: Preservation of live microorganisms without cryoprotectant-induced osmotic stress; maintains colony-forming unit (CFU) viability over extended shelf life.
- Cosmeceutical Development: Lyophilization of peptides, growth factors, and plant stem cell extracts to prevent hydrolysis and enzymatic degradation during storage.
- Pharmaceutical R&D: Formulation screening of sterile injectables, nasal sprays, and ocular delivery systems requiring residual moisture control (<1.0% w/w).
- Biomaterial Processing: Preparation of collagen scaffolds, decellularized tissues, and enzyme-immobilized carriers where pore morphology directly influences biofunctionality.
- Academic Research: Method optimization for novel excipients, freeze-concentration studies, and kinetic modeling of primary drying resistance (Rp) using manometric temperature measurement (MTM) add-ons.
FAQ
Can the TF-FD-1L handle samples containing organic solvents such as ethanol or acetone?
Yes—the <−80 °C cold trap temperature ensures effective condensation of low-vapor-pressure solvents, provided total solvent load remains within the 3 kg/24 h capacity limit and appropriate pump oil filtration is used.
Is in-chamber stoppering performed under vacuum or backfilled with inert gas?
The stoppering mechanism is fully manual and vacuum-actuated; users may introduce nitrogen or argon via an optional gas inlet valve prior to stopper engagement to achieve inert headspace conditions.
What maintenance intervals are recommended for the dual-stage compressor?
Compressor oil should be replaced every 2,000 operating hours or biannually—whichever occurs first—using OEM-specified polyolester (POE) lubricant to maintain thermal stability and moisture resistance.
Does the system support validation documentation (IQ/OQ/PQ)?
Tianfeng provides factory-verified calibration certificates for vacuum gauge and temperature sensor; full qualification packages (including protocol templates and witness reports) are available upon request for regulated facility deployment.
Can the shelf temperature be controlled or monitored during drying?
No—the TF-FD-1L is a non-heated manifold system; shelf temperature equilibrates passively with chamber conditions. For active shelf heating and programmable ramp/soak cycles, consider the TF-FD-18S series.
