Tianfeng TF-SFD-3 Benchtop Pilot-Scale Freeze Dryer with Stoppering Function
| Brand | Tianfeng |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | Direct Manufacturer |
| Region of Origin | Domestic (China) |
| Model | TF-SFD-3 Stoppering Type |
| Instrument Type | In-situ Pre-freezing & Stoppering Freeze Dryer |
| Application Scope | Pilot-scale Development & Small-batch Production |
| Shelf Area | 0.3 m² |
| Ultimate Vacuum | ≤5 Pa |
| Condensate Capacity (24 h) | 5 kg/24 h |
| Condenser Temperature | −70 °C |
| Main Unit Dimensions | 800 × 1000 × 1700 mm |
Overview
The Tianfeng TF-SFD-3 is a pilot-scale, in-situ pre-freezing freeze dryer engineered for process development, formulation optimization, and small-batch manufacturing under controlled, reproducible conditions. It operates on the fundamental principle of lyophilization—first freezing the product at sub-zero temperatures, then removing ice via sublimation under deep vacuum (≤5 Pa), thereby preserving thermolabile structures such as proteins, enzymes, vaccines, and probiotics. Unlike laboratory-scale units, the TF-SFD-3 bridges the gap between R&D and production: its 0.3 m² shelf area supports multiple vial or tray configurations, while its −70 °C condenser and 5 kg/24 h water vapor capture capacity ensure robust performance during extended drying cycles typical of biopharmaceutical and functional food applications—including fish fillet dehydration, where structural integrity, rehydration kinetics, and volatile compound retention are critical.
Key Features
- In-situ pre-freezing capability eliminates manual transfer between freezer and chamber, reducing contamination risk and ensuring consistent nucleation behavior across batches.
- Electrically actuated stoppering mechanism enables automatic sealing of vials under vacuum or inert gas (via optional N₂/Ar purge valve), supporting aseptic processing requirements for sterile pharmaceutical intermediates.
- Silicone oil–based shelf heating/cooling system delivers uniform temperature distribution (±1 °C accuracy) across all shelves—critical for validating drying uniformity per ICH Q5C and USP .
- Stainless steel 304 drying chamber with high-transparency acrylic observation door allows real-time visual monitoring without vacuum break; integrated LED lighting enhances contrast for morphological assessment.
- Touchscreen HMI with embedded PID control algorithm displays real-time shelf temperature, chamber pressure, condenser temperature, and drying curves—enabling dynamic adjustment of ramp rates and hold times based on product-specific drying behavior.
- Modular architecture supports field-upgradable options: PLC-based automation (IEC 61131-3 compliant), Ethernet-enabled remote supervision, co-located eutectic point measurement probe, and FDA 21 CFR Part 11–compliant electronic audit trail when paired with validated software packages.
Sample Compatibility & Compliance
The TF-SFD-3 accommodates diverse sample formats—glass vials (10–50 mL), stainless steel trays (up to 100 mm depth), and custom aluminum pans—making it suitable for lyophilizing aqueous solutions, suspensions, emulsions, and whole tissue slices. Its design conforms to ISO 22000 (food safety), ISO 13485 (medical device QMS), and Good Manufacturing Practice (GMP) Annex 1 principles for aseptic processing. Optional inert gas backfilling meets oxygen-sensitive stability protocols for omega-3-rich fish products, while traceable temperature logging satisfies GLP documentation standards required by regulatory submissions.
Software & Data Management
Standard firmware includes time-stamped data logging (shelf temp, chamber pressure, condenser load) at user-defined intervals (1–60 sec). Optional Tianfeng LyoControl™ software provides CSV export, curve overlay comparison, alarm history review, and password-protected user roles. When configured with PLC and SCADA integration, the system supports automated batch reporting aligned with ISA-88 S88 batch record templates—facilitating audit readiness for FDA, EMA, or NMPA inspections.
Applications
- Pharmaceutical: Optimization of lyoprotectant formulations for monoclonal antibodies, viral vectors, and live attenuated vaccines.
- Food Science: Dehydration of marine-derived peptides, enzymatically active fish hydrolysates, and probiotic-fortified seafood snacks—preserving DHA/EPA content and sensory attributes.
- Agricultural Biotech: Stabilization of microbial inoculants (e.g., Bacillus spp.) and plant growth regulators for shelf-stable biofertilizers.
- Academic Research: Kinetic modeling of primary and secondary drying phases using gravimetric moisture analysis coupled with manometric temperature measurement (MTM).
FAQ
What cooling method does the TF-SFD-3 support?
The unit is available with either air-cooled or water-cooled condenser configurations—selected during ordering to match facility infrastructure and ambient thermal load constraints.
Can the system be validated for GMP use?
Yes. IQ/OQ documentation packages are available upon request; installation includes calibration certificates traceable to NIST standards for all critical sensors.
Is remote monitoring supported out of the box?
Basic Ethernet connectivity is standard; full remote operation and alarm notification require optional PLC + cloud gateway configuration.
What vacuum pump options are compatible?
Tianfeng certifies compatibility with Edwards nXDS, Leybold DRYVAC, and Busch R5 series pumps; pump selection impacts ultimate vacuum attainment and oil carryover risk.
Does the stoppering function operate under full vacuum?
Yes—the pneumatic stoppering actuator engages only after chamber pressure reaches ≤10 Pa, ensuring reliable seal formation without vial deformation.
