Tianfeng TF-SFD-5 Stoppering Pilot-Scale In-Situ Freeze Dryer
| Brand | Tianfeng |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | Direct Manufacturer |
| Product Category | Domestic |
| Model | TF-SFD-5 Stoppering Type |
| Instrument Type | Stoppering Freeze Dryer |
| Application Scale | Pilot-Scale |
| Shelf Area | 0.5 m² |
| Ultimate Vacuum | ≤5 Pa |
| Condenser Capacity (24 h) | 8 kg/24 h |
| Condenser Temperature | ≤−70 °C |
| Main Unit Dimensions (W×D×H) | 800×800×800 mm |
| Shelf Dimensions (W×L) | 278×460 mm |
| Shelf Spacing | 70 mm |
| Number of Shelves | 4 + 1 (top shelf for temperature calibration) |
| Shelf Temperature Range | −50 to +80 °C |
| Shelf Temperature Uniformity | ≤±1 °C |
| Total Power Consumption | 4.5 kW |
| Net Weight | 500 kg |
| Maximum Loading Volume | 8 L |
| Vial Capacity (Φ16 mm) | 2112 pcs/batch |
| Vial Capacity (Φ20 mm) | 1056 pcs/batch |
Overview
The Tianfeng TF-SFD-5 Stoppering Pilot-Scale In-Situ Freeze Dryer is an engineered solution for controlled lyophilization of thermolabile biopharmaceuticals, diagnostics, and functional biomaterials under GMP-aligned process conditions. Operating on the principle of sublimation under deep vacuum, this system performs primary drying below the eutectic temperature of the formulation and secondary drying at elevated shelf temperatures—typically up to +80 °C—while maintaining structural integrity and biological activity. Unlike conventional thermal drying methods that induce denaturation, oxidation, or collapse, in-situ freeze drying preserves native conformation through ice matrix templating, yielding a highly porous, reconstitutable cake with minimal residual moisture (<1.5% w/w, typical). Designed for scalability from lab-scale formulation development to early-phase clinical batch production, the TF-SFD-5 bridges the gap between benchtop units and full production lyophilizers—supporting process characterization, cycle optimization, and regulatory documentation required for FDA 21 CFR Part 11 and EU Annex 11 compliance.
Key Features
- In-situ pre-freezing and drying within a single chamber eliminates manual transfer, reducing contamination risk and ensuring consistent nucleation behavior.
- Silicone oil-heated shelves deliver precise, programmable temperature control across all five shelves, with inter-shelf uniformity maintained at ≤±1 °C—critical for reproducible drying kinetics and product homogeneity.
- Integrated stoppering mechanism enables automatic, vacuum-compatible sealing of vials post-drying, supporting aseptic processing workflows without exposure to ambient air.
- PLC-based control system with 7-inch resistive touchscreen interface supports up to five independent drying programs; each program accommodates 24 customizable segments (freezing ramp, hold, primary drying slope, secondary drying ramp, etc.).
- Real-time data acquisition logs shelf temperature, chamber pressure, condenser temperature, and time-stamped operator actions—enabling full audit trail generation per ALCOA+ principles.
- Optional in-chamber eutectic point detection module allows empirical determination of critical formulation temperatures, facilitating robust cycle design per ICH Q5C and Q8(R2) guidelines.
- High-efficiency dual-stage cascade condenser achieves ≤−70 °C operating temperature and handles up to 8 kg of water vapor per 24-hour cycle—reducing drying duration by up to 30% compared to single-stage systems.
- Transparent acrylic door with anti-fog coating permits continuous visual monitoring of cake formation, collapse events, and vial integrity throughout the entire cycle.
- Equipped with inert gas inlet valve (N₂ or argon compatible) for backfilling under controlled atmosphere prior to stoppering—essential for oxygen-sensitive monoclonal antibodies or live viral vaccines.
Sample Compatibility & Compliance
The TF-SFD-5 accommodates standard pharmaceutical vials (Φ16 mm and Φ20 mm), serum bottles, and custom trays up to 278 mm × 460 mm. Its 0.5 m² effective shelf area supports batch sizes ranging from 1 to 8 liters of aqueous formulation. The system meets mechanical and electrical safety requirements per IEC 61010-1 and complies with CE marking directives for laboratory equipment. Data integrity features—including user-level access control (password-protected administrator mode), electronic signatures, and immutable event logs—align with FDA 21 CFR Part 11, EU GMP Annex 11, and ISO/IEC 17025 traceability standards. All wetted surfaces are electropolished stainless steel (AISI 316L), and the chamber is certified for use with non-toxic, non-corrosive solvents commonly employed in biologics formulation (e.g., tert-butanol, ethanol/water mixtures).
Software & Data Management
The embedded HMI runs proprietary Tianfeng LyoControl™ firmware, supporting CSV export of time-series process data (shelf temp, chamber pressure, condenser temp, vacuum rate) with millisecond-level timestamp resolution. Raw data files include metadata headers compliant with ASTM E2500-19 for analytical instrument qualification. Optional Ethernet/IP connectivity enables integration into centralized SCADA or MES platforms via Modbus TCP. Audit trails record all parameter modifications, login/logout events, alarm acknowledgments, and emergency stops—retained for ≥36 months unless purged under documented retention policy. Software validation packages (IQ/OQ documentation templates) are available upon request for regulated environments.
Applications
This system is routinely deployed in: (1) Development and optimization of lyophilization cycles for monoclonal antibodies, recombinant proteins, and mRNA-LNP formulations; (2) Stability studies per ICH Q1A–Q1E under accelerated and real-time conditions; (3) Production of reference standards and calibration materials for QC laboratories; (4) Processing of diagnostic reagents including ELISA kits, PCR master mixes, and lateral flow assay components; (5) Preservation of microbial cultures, stem cell derivatives, and tissue-engineered constructs requiring long-term cryostorage without cryoprotectants.
FAQ
What is the maximum allowable load volume per batch?
The system supports up to 8 liters of total fill volume across 2112 × Φ16 mm vials or 1056 × Φ20 mm vials, assuming standard fill depth of 10 mm.
Does the unit support automated cycle validation?
Yes—programmable logic control enables repeatable execution of predefined protocols, and all operational parameters are logged with digital signatures for retrospective validation per FDA guidance.
Can the condenser handle solvent-laden vapors (e.g., tert-butanol)?
The condenser is rated for aqueous systems only; co-solvent use requires prior consultation with Tianfeng engineering to assess frost accumulation and defrost cycle compatibility.
Is remote monitoring supported out of the box?
Standard configuration includes local HMI only; optional Ethernet module enables remote viewing of real-time trends and alarm status via secure web interface.
What calibration certificates are supplied with delivery?
Each unit ships with factory-calibrated PT100 shelf sensors (traceable to NIST standards), vacuum gauge certificate, and condenser thermocouple report—all valid for 12 months.
