Tianfeng SFD-5㎡ Benchtop Pilot-Scale Lyophilizer with Hydraulic Stoppering System

Overview

The Tianfeng SFD-5㎡ Benchtop Pilot-Scale Lyophilizer is an in-situ freeze drying system engineered for reproducible, scalable process development and small-batch cGMP-compliant production. It operates on the fundamental principles of sublimation under controlled low-pressure and low-temperature conditions: frozen product water transitions directly from solid to vapor phase without passing through liquid state, preserving thermolabile structures such as proteins, enzymes, probiotics, and botanical actives. Designed for seamless transition from lab-scale formulation optimization to pilot-scale validation, this unit integrates primary drying, secondary drying, and stoppering—all within a single stainless-steel chamber. Its 0.5 m² shelf area supports vial-based or tray-based loading configurations, enabling systematic parameter mapping (shelf temperature, chamber pressure, condenser load) essential for defining robust lyophilization cycles per ICH Q5C and USP guidelines.

Key Features

• In-situ pre-freezing and drying eliminate manual transfer between freezer and dryer—reducing contamination risk and improving batch consistency.
• Hydraulic stoppering system (SW-FA-40/18-250) delivers precise, programmable sealing force (0–1 ton), compatible with standard pharmaceutical-grade rubber stoppers and ISO-standard vial formats (e.g., 16 mm OD: up to 2160 vials; 22 mm OD: up to 1130 vials).
• Double-jacketed stainless steel shelves use silicone oil as thermal medium, ensuring uniform temperature distribution (±1 °C deviation across surface) and enabling precise control over primary drying rate and residual moisture profiles.
• Self-contained cascade refrigeration architecture employs high-efficiency imported compressors, achieving ≤−70 °C condenser temperature and 25 L/24 h ice capacity—critical for high-moisture formulations and extended drying cycles.
• High-transparency acrylic door allows real-time visual monitoring of cake formation, collapse events, and sublimation front progression without vacuum interruption.
• PLC-based TF-HOS-V1 control platform supports multi-stage recipe programming, on-the-fly parameter adjustment during drying, stage-skipping, and full-cycle audit trail generation—including timestamps, operator ID, and setpoint deviations.
• Corrosion-resistant 304 stainless steel construction (chamber, condenser, shelves, and frame) meets ASME BPE surface finish requirements (Ra ≤ 0.8 µm) for pharmaceutical applications.

Sample Compatibility & Compliance

The SFD-5㎡ accommodates diverse sample forms: sterile vials (glass or polymer), aluminum-sealed trays, and custom molds for food powders or cosmetic matrices. Its validated operating envelope supports aqueous solutions, suspensions, emulsions, and viscous biologics with total solids content ranging from 2% to 40%. The system complies with ISO 9001:2000 quality management standards throughout design, assembly, and factory testing. While not supplied with out-of-box 21 CFR Part 11 compliance, the TF-HOS-V1 firmware supports optional software upgrades enabling electronic signatures, role-based access control, and immutable data archiving—facilitating GLP/GMP audits. All wetted surfaces are electropolished and passivated per ASTM A967, and the unit can be qualified per IQ/OQ protocols using third-party calibration equipment (e.g., calibrated PT100 probes, capacitance manometers, and moisture analyzers).

Software & Data Management

The embedded HMI features a 10.1-inch resistive touchscreen with intuitive icon-driven navigation. Process data—including shelf temperature, chamber pressure, condenser temperature, and time—is logged at user-defined intervals (1 s to 10 min resolution) and stored with unique batch identifiers. Both graphical trend curves and tabular numeric exports (CSV format) are available via USB port. Historical batches can be recalled, compared side-by-side, or annotated for root cause analysis. For regulated environments, optional firmware modules provide electronic signature capture, change control logs, and automatic backup to network drives—aligning with Annex 11 and ALCOA+ data integrity principles. No cloud connectivity is enabled by default; all data remains local unless explicitly configured by the user.

Applications

This lyophilizer serves cross-industry R&D and pilot manufacturing needs: pharmaceutical developers use it for stability studies of monoclonal antibodies and mRNA-LNPs; nutraceutical labs dry heat-sensitive herbal extracts and probiotic cultures while retaining viability >95%; food scientists produce instant coffee, fruit powders, and functional ingredient blends with minimal Maillard browning; and materials researchers stabilize enzyme-loaded hydrogels or nanostructured catalysts for subsequent characterization. Its modular architecture also supports integration into automated fill-finish lines via RS485/Modbus RTU interface for coordinated start/stop signaling and status feedback.

FAQ

What is the maximum vial capacity for 22 mm OD serum vials?
Up to 1,130 vials when loaded in standard hexagonal pattern on 0.5 m² shelves.
Can the system operate under inert gas purge?
Yes—integrated nitrogen or argon inlet valve enables controlled backfilling to ≤0.2 bar gauge prior to stoppering.
Is remote monitoring supported?
Local Ethernet port enables connection to facility SCADA systems; remote desktop access requires on-site IT approval and firewall configuration.
What validation documentation is provided?
Factory acceptance test (FAT) report, calibration certificates for all critical sensors, and mechanical completion checklist are included; IQ/OQ protocol templates are available upon request.
Does the hydraulic stoppering system require external power or air supply?
No—it uses an integrated 0.75 kW electric hydraulic unit with ISO VG 46 anti-wear mineral oil; no compressed air or external pump is needed.