Tianfeng TF-SFD Series Benchtop Pilot-Scale Freeze Dryer with In-Situ Pre-Freezing and Silicone Oil Heating

Overview

The Tianfeng TF-SFD Series is a pilot-scale, in-situ freeze dryer engineered for reproducible lyophilization of pharmaceutical, biotechnological, and research-grade formulations under controlled thermal and vacuum conditions. It operates on the fundamental principle of sublimation—removing water from frozen samples under high vacuum while maintaining product integrity through precise shelf temperature modulation via silicone oil circulation. Unlike batch-loading systems requiring manual transfer between freezing and drying chambers, the TF-SFD integrates pre-freezing directly on the heated shelves, eliminating thermal shock, minimizing contamination risk, and ensuring consistent ice nucleation across all vials or trays. Designed for GMP-aligned process development labs, it supports scalable parameter translation from lab-scale to manufacturing, with validated thermal uniformity (≤±1 °C shelf-to-shelf and point-to-point), real-time vacuum monitoring, and full-cycle data traceability.

Key Features

• In-situ pre-freezing capability with programmable shelf ramping and hold steps—eliminates need for external ultra-low temperature freezers
• Silicone oil heating/cooling system delivering exceptional thermal stability and uniformity (≤1 °C max shelf temperature deviation)
• High-transparency, non-fogging acrylic door enabling continuous visual monitoring of cake formation, collapse, and drying front progression
• Touchscreen HMI with embedded controller supporting up to 5 customizable protocols, each with up to 24 independent time–temperature–vacuum segments
• Real-time graphical logging of shelf temperature, chamber pressure, condenser temperature, and process duration—with timestamped audit trail
• Optional integrated eutectic point detection module for empirical determination of critical formulation temperatures
• Dry nitrogen or argon backfill valve (standard) for inert atmosphere stabilization post-drying and enhanced product stability
• Modular PLC architecture (optional) compliant with IEC 61131-3 standards, supporting Ethernet/IP, Modbus TCP, and remote SCADA integration
• Stainless steel 316L drying chamber and condenser housing—electropolished finish available per user specification
• Configurable cooling interface: air-cooled or water-cooled condenser options to accommodate facility constraints

Sample Compatibility & Compliance

The TF-SFD accommodates standard pharmaceutical primary packaging—including 16 mm and 20 mm serum vials (up to 770 and 400 units per cycle, respectively), flat-bottom trays (max 3 L total fill volume), and custom stainless steel or aluminum pans. Its design conforms to core elements of ISO 22042:2016 (freeze-drying equipment performance criteria) and supports alignment with USP , EU Annex 1, and FDA Guidance for Industry: Lyophilization Process Validation. Data integrity complies with ALCOA+ principles; optional 21 CFR Part 11-compliant software package provides electronic signatures, role-based access control, and immutable audit logs. All electrical components meet CE and GB/T 14048.1 safety standards.

Software & Data Management

Standard firmware includes local data storage (SD card or internal flash) with CSV export capability for offline analysis in MATLAB, Python, or commercial CQV tools. Optional Tianfeng LyoControl™ software enables PC-based protocol editing, live multi-channel graphing, automated report generation (PDF/Excel), and trend analysis across batches. The system logs all operator actions—including parameter changes during active runs—with user ID, timestamp, and reason-for-change fields. For regulated environments, the validated software package includes electronic signature workflows, password-protected administrator mode, and configurable retention policies meeting GLP/GMP record-keeping requirements.

Applications

• Pharmaceutical formulation development: optimization of annealing, primary drying rate, and secondary drying endpoints for monoclonal antibodies, vaccines, and small-molecule APIs
• Biologics stability studies: accelerated and real-time shelf-life assessment under defined residual moisture targets (≤1.5% w/w)
• Diagnostic reagent lyophilization: preservation of enzyme activity and antigen binding affinity in lateral flow and ELISA kits
• Academic and contract research: reproducible freeze-drying of cell lysates, plasmid DNA, exosomes, and tissue extracts without structural denaturation
• Medical device coating: immobilization of antimicrobial peptides or growth factors onto porous scaffolds via lyophilized deposition

FAQ

What is the maximum allowable load volume for the TF-SFD-2 model?

The standard TF-SFD-2 configuration supports up to 3 L of aqueous solution across its 0.2 m² shelf area, corresponding to approximately 770 vials (Φ16 mm) or 400 vials (Φ20 mm) at typical fill volumes of 1.5–2 mL.
Can the system be validated for GMP production use?

Yes—the TF-SFD platform is designed to support IQ/OQ/PQ execution. Documentation packages (DQ, FAT/SAT protocols, calibration certificates) are provided. Optional IQ/OQ assistance and vendor-led PQ support are available upon request.
Is remote monitoring supported out of the box?

Basic Ethernet connectivity is standard; full remote operation and alarm notification require the optional PLC + LyoControl™ package with secure VPN-configurable access.
What vacuum pump options are compatible?

Tianfeng certifies compatibility with Edwards nXDS, Leybold TRIVAC, and Busch R5 series oil-sealed rotary vane pumps, as well as dry scroll pumps (e.g., Agilent TwisTorr) for solvent-sensitive applications.
Does the system support automatic stoppering?

No—the TF-SFD series is a non-pressurized, open-chamber design. Stoppering requires integration with a separate capper or a custom-engineered stopper insertion module (available as third-party retrofit).