Tianfeng TF-SFD-10 Pilot-Scale Freeze Dryer with In-Situ Pre-Freezing and Hydraulic Oil Heating System

Overview

The Tianfeng TF-SFD-10 is a pilot-scale, in-situ pre-freezing freeze dryer engineered for reproducible lyophilization of heat-sensitive biologicals, botanical extracts, and functional food powders—including raspberry puree, coffee and milk tea concentrates, oolong tea infusions, and microbial cultures. It operates on the fundamental principle of sublimation: frozen water is removed directly from the solid phase to vapor under controlled low-pressure (<5 Pa) and cryogenic condensation (≤−70 °C) conditions, preserving structural integrity, enzymatic activity, and volatile compound profiles. Unlike benchtop units, the TF-SFD-10 integrates hydraulic oil-heated shelves for precise thermal management across its 1.04 m² active drying area—enabling uniform heat transfer critical for scalable process development and GMP-aligned small-batch production. Its design complies with core engineering requirements for pharmaceutical and food-grade lyophilization, including vacuum integrity, temperature uniformity (±1 °C shelf-to-shelf), and traceable parameter logging.

Key Features

• In-situ pre-freezing: Sample freezing occurs directly on heated shelves—eliminating manual tray transfer and minimizing thermal shock or contamination risk.
• Hydraulic oil circulation heating system: Enables accurate PID-controlled shelf temperature regulation from −50 °C to +80 °C, with inter-shelf deviation ≤±1 °C—essential for consistent primary and secondary drying kinetics.
• 7-shelf configuration (6 usable + 1 base plate): 70 mm spacing accommodates standard vials (Φ16 mm: 3,828 units/batch; Φ20 mm: 2,016 units/batch) and shallow trays up to 13 L total fill volume.
• High-capacity condenser: Rated for ≥16 kg ice capture per 24-hour cycle at ≤−70 °C—supporting high-moisture botanical slurries and microbial suspensions without frost bridging.
• Full-featured PLC control with 10.1″ color HMI: Supports 5 user-defined protocols (24 segments each), real-time vacuum & shelf temperature curve overlay, on-run parameter adjustment, and full operational audit trail.
• Process-enabling hardware options: Integrated inert gas backfill valve (for O₂-sensitive samples), optional in-line eutectic point detection probe, and Ethernet-enabled remote monitoring compatible with LabArchives or electronic lab notebook (ELN) integration.

Sample Compatibility & Compliance

The TF-SFD-10 accommodates diverse sample formats—liquid suspensions, pastes, gels, and cell pellets—in glass vials, stainless steel trays, or custom silicone molds. It is routinely validated for lyophilization of lactic acid bacteria (LAB), yeast strains (e.g., Saccharomyces cerevisiae), spore-forming Bacillus species, viral vectors, and polyphenol-rich plant extracts. The system meets foundational requirements for GLP-compliant strain preservation per ISO 11133 and USP , supporting long-term viability (5–15 years) when used with standard protectants (skim milk, trehalose, dextran). Vacuum integrity and temperature uniformity are verifiable via IQ/OQ protocols; data logs comply with FDA 21 CFR Part 11 Annex 11 expectations for electronic records and signatures when paired with validated software configurations.

Software & Data Management

The embedded HMI records all critical process variables—including shelf temperature (per shelf), chamber pressure, condenser temperature, and elapsed time—at configurable intervals (1–60 s). All logs are timestamped, user-identified, and stored internally with export capability via USB or Ethernet. Modifications to active protocols are logged with operator ID and timestamp. Optional SCADA integration allows centralized fleet monitoring across multi-unit installations. Raw data exports support CSV and PDF report generation—structured for inclusion in regulatory submissions (e.g., CMC sections of IND/MAA dossiers) or internal quality review workflows.

Applications

• Microbial culture preservation: Stabilization of bacterial, fungal, and actinomycete strains for biobanking, QC reference standards, and fermentation inoculum preparation.
• Botanical powder manufacturing: Lyophilization of cold-sensitive fruit pulps (raspberry), roasted coffee extracts, dairy-tea emulsions, and oxidatively labile oolong tea catechins—retaining aroma, color, and antioxidant capacity.
• Vaccine and diagnostic reagent development: Stabilization of antigen-antibody conjugates, ELISA kits, and rapid test strip components requiring room-temperature shelf life.
• Pharmaceutical intermediate processing: Primary drying of sterile-filtered protein solutions, peptide formulations, and nanosuspensions prior to stoppering.
• Academic & contract research: Method development for novel excipient systems, drying rate optimization, and thermophysical property mapping (e.g., collapse temperature, Tg′).

FAQ

What is the maximum batch capacity for liquid samples?
The TF-SFD-10 supports up to 13 L of aqueous solution per batch, distributed across its 1.04 m² shelf area—optimized for uniform ice layer thickness and efficient sublimation front propagation.
Does the system support automatic stoppering post-drying?
Yes—the TF-SFD-10 is configured as a stoppering model with pneumatically actuated stainless-steel stopper rods, enabling aseptic closure under vacuum or inert gas backfill.
Can shelf temperature be ramped independently during primary and secondary drying?
Absolutely. Each of the 5 stored protocols allows independent ramp/hold settings per segment—including dynamic shelf temperature modulation synchronized with pressure feedback to prevent melt-back or collapse.
Is validation documentation available for GMP environments?
Tianfeng provides IQ/OQ templates, FAT/SAT reports, and material traceability records (3.1 certs for key components); final PQ must be executed by the end user per site-specific SOPs and applicable regional regulations.
What maintenance intervals are recommended for the vacuum pump and refrigeration system?
Oil-sealed rotary vane pumps require oil change every 500 operating hours; the dual-stage cascade refrigeration system is rated for 15,000 hours MTBF—annual leak testing and condenser coil inspection are advised.