Tianfeng TF-SFD-40E Industrial-Scale Pharmaceutical Freeze Dryer
| Brand | Tianfeng |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | OEM Manufacturer |
| Origin Category | Domestic (China) |
| Model | TF-SFD-40E |
| Instrument Type | Standard Shelf-Type Freeze Dryer |
| Application Scope | Production-Scale |
| Lyophilization Area | 40.5 m² |
| Ultimate Vacuum | 2.7 Pa |
| Condenser Capacity (24 h) | 750 kg |
| Condenser Temperature | −75 °C |
| Main Unit Dimensions | 9000 × 3000 × 4600 mm |
Overview
The Tianfeng TF-SFD-40E is a fully integrated, cGMP-compliant industrial freeze dryer engineered for high-volume lyophilization of pharmaceuticals, biologics, and cosmetic formulations. Designed according to the fundamental principles of sublimation-based drying under deep vacuum and controlled shelf temperature gradients, this system enables precise thermal management across large-scale batches while maintaining product integrity, structural stability, and reconstitution performance. With a total shelf area of 40.5 m² and a condenser rated at −75 °C with 750 kg/24 h ice-trapping capacity, the TF-SFD-40E supports continuous production cycles in compliance with ICH Q5C, Q5D, and USP requirements for sterile and non-sterile lyophilized products.
Key Features
- Stainless steel chamber constructed from AISI 304 with fully polished, radius-minimized internal geometry to eliminate dead zones and facilitate cleaning-in-place (CIP) and sterilization-in-place (SIP) validation.
- Fifteen + one stainless steel shelves (1515 mm × 1830 mm each), manufactured via uniform thermal stress-relief annealing to ensure ≤ ±0.15 mm flatness tolerance—critical for consistent vial-to-shelf heat transfer and uniform cake morphology.
- Shelf temperature range: −55 °C to +70 °C, regulated using low-viscosity silicone oil as the primary heat transfer medium; ensures ≤ ±0.5 °C inter-shelf uniformity at all operating points.
- PLC-based control architecture with redundant safety interlocks, real-time data logging, and full audit trail functionality compliant with FDA 21 CFR Part 11 requirements.
- Integrated vacuum system achieving ≤ 2.7 Pa ultimate pressure with leak rate ≤ 0.1 Pa·m³/s, verified per ISO 20517 and ASTM E493.
- Electrical heating power: 80 kW; total installed power: 222 kW; designed for stable operation under industrial three-phase 380 V / 50 Hz supply.
Sample Compatibility & Compliance
The TF-SFD-40E accommodates diverse container formats including 182,200 units of Ø16 mm vials or 93,000 units of Ø22 mm vials per batch, or up to 800 L of bulk solution. Its engineering adheres to ISO 9001:2015 quality management standards and incorporates design elements aligned with EU Annex 1 (2022), WHO TRS 986, and ASME BPE-2022 for pharmaceutical process equipment. All wetted surfaces meet electropolished Ra ≤ 0.4 µm specifications. The system supports full qualification documentation packages—including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)—and is compatible with third-party 3Q certification services.
Software & Data Management
Control logic resides in a validated Siemens S7-1500 PLC platform interfaced with a 15-inch industrial touchscreen HMI. Process recipes—including shelf ramp/soak profiles, vacuum ramping sequences, and condenser defrost cycles—are stored in encrypted memory with version-controlled revision history. Data export supports CSV, PDF, and XML formats; time-stamped records include shelf temperature, chamber pressure, condenser temperature, and product thermocouple readings (optional). Electronic signatures, user role-based access control, and automated backup to external NAS devices are configurable to meet GLP/GMP data integrity expectations.
Applications
This freeze dryer serves as a core unit in commercial manufacturing suites for monoclonal antibodies, recombinant proteins, live attenuated vaccines, and lyophilized cosmetic actives (e.g., peptides, growth factors, hyaluronic acid derivatives). It supports cycle development studies for Phase III clinical trial material and commercial launch batches. Its robust architecture allows integration into larger automation frameworks via Modbus TCP or OPC UA protocols, enabling alignment with MES and SCADA systems in Industry 4.0 environments.
FAQ
Is the TF-SFD-40E suitable for aseptic processing?
Yes—the chamber and door sealing system are qualified for Class A (ISO 5) environments when installed within an isolator or RABS configuration.
Can the system be validated for regulatory submission?
Yes—Tianfeng provides complete DQ/IQ/OQ/PQ templates and supports on-site execution by qualified third-party vendors.
What is the typical lead time for delivery?
Standard delivery is 5–7 working days after order confirmation; custom configurations may require 8–12 weeks depending on scope.
Does the system support remote monitoring and diagnostics?
Yes—optional Ethernet-enabled remote access module permits secure web-based supervision and predictive maintenance alerts.
Are spare parts and technical support available globally?
Yes—Tianfeng maintains regional service hubs in Asia, Europe, and North America, with 24/7 hotline support and certified field engineers.
