Tianfeng TF-SFD-10E Pharmaceutical-Grade Lyophilizer with Stoppering Function

Overview

The Tianfeng TF-SFD-10E is a production-scale, shelf-type pharmaceutical lyophilizer engineered for sterile, cGMP-compliant freeze-drying of thermolabile biologics—including peptides, monoclonal antibodies, vaccines, plasma derivatives, and small-molecule APIs. It operates on the fundamental principle of sublimation: aqueous samples are first frozen solid at controlled low temperatures (≤−55 °C), then subjected to high vacuum (≤2.7 Pa) while applying precisely regulated conductive heat via silicone oil–circulated shelves. This enables direct phase transition of ice to vapor without passing through the liquid state—preserving structural integrity, biological activity, and chemical stability of sensitive molecules. Unlike laboratory-scale units, the TF-SFD-10E integrates process-critical subsystems—including a −75 °C dual-stage cascade condenser, PLC-driven shelf temperature ramping, automated stoppering under vacuum or inert gas, and full traceability architecture—into a single monolithic chamber designed for repeatable, scalable, and auditable manufacturing.

Key Features

• Stainless steel (AISI 304) chamber with fully polished, zero-dead-leg internal geometry—compliant with ASME BPE surface finish requirements (Ra ≤ 0.8 µm) and optimized for CIP/SIP compatibility.
• Ten square meters of total shelf area (10.33 m²), configured across 9 operational shelves + 1 preconditioning shelf, enabling batch capacities up to 46,400 vials (Ø16 mm) or 23,700 vials (Ø22 mm).
• High-efficiency dual-stage cascade refrigeration system maintaining stable condenser temperature at −75 °C; supports continuous ice capture up to 50 kg per 24-hour cycle and total holding capacity of 220 kg.
• Low-viscosity silicone oil thermal transfer medium ensures ±0.5 °C uniformity across shelf surfaces—even at extreme low-temperature setpoints—critical for consistent primary drying kinetics.
• PLC-based control system (Siemens S7 series) with validated HMI interface, supporting recipe storage, real-time parameter logging, alarm management, and electronic signature functionality per FDA 21 CFR Part 11 Annex 11 requirements.
• Integrated stoppering mechanism with pneumatically actuated stainless steel rams, capable of crimping rubber stoppers under vacuum or nitrogen backfill—ensuring headspace control and sterility maintenance post-drying.
• Comprehensive mechanical and electrical design certified to ISO 9001:2015 quality management standards; documentation package includes FAT/SAT protocols and full 3Q (IQ/OQ/PQ) validation support files.

Sample Compatibility & Compliance

The TF-SFD-10E accommodates diverse dosage forms including bulk solutions (up to 220 L), filled vials, syringes, and trays—making it suitable for clinical-phase manufacturing as well as commercial-scale GMP production. Its chamber geometry and shelf layout comply with EMA Annex 1 and USP environmental classification expectations when installed in Grade B/C cleanrooms. All wetted parts meet USP Class VI biocompatibility criteria. The system’s leak rate (<0.1 Pa·m³/s) satisfies ICH Q5C stability protocol prerequisites for long-term lyophilization cycle reproducibility. Process data integrity adheres to ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available), ensuring audit readiness for FDA, EMA, PMDA, and NMPA inspections.

Software & Data Management

Equipped with a validated SCADA-level supervisory software suite, the TF-SFD-10E records time-stamped, tamper-evident datasets for all critical process parameters—including shelf temperature, chamber pressure, condenser temperature, product thermocouple readings (optional), and vacuum pump status. Raw data is stored in encrypted binary format with SHA-256 checksum verification and exported to CSV or PDF upon request. Audit trails are immutable and retain full operator identity, timestamp, and action context—fully compliant with 21 CFR Part 11 electronic record and signature requirements. Optional integration with MES/ERP systems via OPC UA or Modbus TCP enables centralized batch record compilation and deviation tracking within enterprise quality management systems (eQMS).

Applications

• Pharmaceutical development and manufacturing of sterile injectables—particularly peptide-based therapeutics requiring conformational stability post-reconstitution.
• Lyophilization of diagnostic reagents, ELISA kits, PCR master mixes, and reference standards where enzymatic activity or antigenicity must be preserved.
• Stabilization of cell therapies, exosomes, and viral vectors prior to cryopreservation or distribution.
• Processing of botanical extracts (e.g., ginseng, cordyceps) and functional food ingredients where volatile compound retention and color fidelity are essential.
• Research-scale formulation optimization using Design of Experiments (DoE) workflows, supported by programmable ramp/hold profiles and multi-zone shelf control.

FAQ

Does the TF-SFD-10E support automatic stoppering under inert gas?

Yes—the system includes integrated nitrogen or argon purge capability during stoppering, with adjustable flow control and residual oxygen monitoring (optional sensor).
Can the unit be validated for use in FDA-submitted BLA or MAA filings?

Absolutely. Tianfeng provides full 3Q documentation packages—including risk assessments, URS, FDS, SDS, trace matrices, and executed protocols—aligned with ISPE GAMP5 and ASTM E2500 standards.
What level of training and after-sales support is included?

Standard offering includes on-site installation qualification, 5-day operator and maintenance technician training, and 24-month comprehensive warranty covering parts, labor, and remote diagnostics.
Is the control system compatible with existing facility automation infrastructure?

Yes—native Modbus TCP and optional OPC UA connectivity enable seamless integration with DeltaV, PCS7, or other DCS platforms for centralized monitoring and alarm aggregation.
How is cleaning-in-place (CIP) implemented on this lyophilizer?

The chamber and shelves feature dedicated spray ball manifolds connected to purified water and WFI loops; CIP sequence logic is embedded in the PLC and fully configurable within the HMI.