Tianfeng SFD-3E Pharmaceutical-Grade Production Freeze Dryer
| Brand | Tianfeng |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | OEM Manufacturer |
| Region Category | Domestic (China) |
| Model | SFD-3E |
| Instrument Type | Standard Shelf-Type Freeze Dryer |
| Application Scope | Production-Scale |
| Lyophilization Area | 3 m² |
| Ultimate Vacuum | 2.7 Pa |
| Condenser Capacity (24 h) | 65 kg |
| Condenser Temperature | −75 °C |
| Main Unit Dimensions | 4.5 × 1.8 × 3.3 m |
Overview
The Tianfeng SFD-3E is a cGMP-compliant, production-scale freeze dryer engineered for the reliable and reproducible lyophilization of thermolabile pharmaceuticals—including biologics, antibiotics, natural drug extracts, sterile injectables, oral disintegrating tablets (ODTs), and lyophilized capsules. Operating on the fundamental principles of sublimation under deep vacuum and controlled heat transfer via silicone oil–circulated shelves, the SFD-3E delivers precise thermal management across its five active shelves plus one auxiliary shelf. Its design integrates validated process control architecture with structural integrity aligned to ISO 9001:2015 quality system requirements and current Good Manufacturing Practice (cGMP) guidelines per FDA 21 CFR Part 211 and EU Annex 1. The chamber’s AISI 304 stainless steel construction—featuring fully polished, radius-rounded internal corners and stress-relieved shelf welding—ensures cleanability, minimizes microbial harborage points, and supports routine sterilization-in-place (SIP) or vaporized hydrogen peroxide (VHP) decontamination protocols.
Key Features
- Lyophilization chamber with 3 m² total shelf area, accommodating up to 13,300 vials (Φ16 mm) or 6,800 vials (Φ22 mm), plus 60 L maximum bulk solution capacity
- Five temperature-controlled shelves (plus one auxiliary) with ±0.5 °C uniformity across full operating range (−55 °C to +70 °C), enabled by low-viscosity silicone oil circulation
- High-efficiency condenser operating at −75 °C with 65 kg/24 h ice capture capacity and leak rate ≤0.1 Pa·m³/s
- Ultimate vacuum capability of ≤2.7 Pa, maintained via dual-stage oil-lubricated vacuum pump assembly with integrated vacuum gauge and pressure regulation
- PLC-based automation system with HMI touchscreen interface, supporting recipe storage, real-time parameter logging, alarm management, and audit-trail-enabled operation per FDA 21 CFR Part 11 requirements
- Full compliance with ASME BPVC Section VIII Div. 1 (pressure vessel code), PED 2014/68/EU, and CE marking for machinery safety (2006/42/EC)
Sample Compatibility & Compliance
The SFD-3E accommodates diverse sample formats including glass vials, trays, and bulk containers, making it suitable for clinical batch manufacturing, pilot-scale process development, and commercial intermediate drying. Its shelf geometry (615 mm width × 915 mm depth, 100 mm spacing) ensures optimal radiation and conduction heat transfer during primary and secondary drying phases. All wetted surfaces meet USP Class VI biocompatibility standards; gasket materials are FDA-listed silicone or EPDM. The system supports full validation documentation packages—including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)—aligned with ICH Q5C, Q5D, and ISO 20957 standards for lyophilized product stability.
Software & Data Management
The embedded PLC controller runs proprietary lyophilization software enabling multi-step ramp-hold programs with dynamic shelf temperature and chamber pressure modulation. Data acquisition includes continuous recording of shelf temperature, condenser temperature, chamber pressure, product temperature (via optional thermocouple ports), and vacuum pump status. Raw data is stored in CSV format with time-stamped, user-identifiable entries. Electronic signatures, role-based access control, and automatic backup to external USB drives satisfy ALCOA+ data integrity principles. Optional integration with MES or SCADA systems is supported via Modbus TCP or OPC UA protocols.
Applications
- Stabilization of monoclonal antibodies, vaccines, and recombinant proteins
- Drying of antibiotic powders (e.g., penicillins, cephalosporins) while preserving potency and crystallinity
- Manufacturing of probiotic formulations requiring high viability retention post-lyophilization
- Processing of botanical extracts and traditional Chinese medicine (TCM) intermediates sensitive to thermal degradation
- Development and scale-up of lyophilized oral dosage forms compliant with USP <797> and <1116>
- Preparation of reference standards and calibration materials for QC laboratories
FAQ
Does the SFD-3E support automated cycle development and optimization?
Yes—the system allows creation and execution of multi-segment freeze-drying cycles with programmable shelf temperature ramps, hold durations, and pressure-controlled drying steps.
Is 3Q documentation included as standard?
DQ/IQ/OQ documentation templates are provided; PQ execution requires site-specific protocol development and witness by qualified personnel.
Can the unit be configured for steam-in-place (SIP) or VHP decontamination?
Chamber and condenser are SIP-capable with optional jacketed door and integrated temperature mapping ports; VHP compatibility confirmed per ISO 14644-3 Class 5 environmental requirements.
What electrical supply and utility connections are required?
30 kW total connected load (3-phase, 380 VAC ±10%, 50 Hz); chilled water supply (≤12 °C) for condenser cooling; compressed air (6 bar, oil-free) for valve actuation.
Is remote monitoring and troubleshooting supported?
Ethernet connectivity enables secure remote diagnostics via VPN; optional cloud-based telemetry module available for predictive maintenance alerts.
