Tianfeng TF-LYO-5 CIP Industrial Pharmaceutical Freeze Dryer
| Brand | Tianfeng |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | Direct Manufacturer |
| Product Category | Domestic |
| Model | TF-LYO-5 CIP |
| Instrument Type | Stoppering (Hydraulic/Manual Lid Press) Freeze Dryer |
| Application Scope | Production-Scale |
| Shelf Area | 5 m² |
| Ultimate Vacuum | 2.7 Pa |
| Condenser Capacity (24 h) | 105 kg/24 h |
| Condenser Temperature | –75 °C |
| Main Unit Dimensions (W×D×H) | 430 × 230 × 370 cm |
Overview
The Tianfeng TF-LYO-5 CIP is a fully integrated, cGMP-compliant industrial freeze dryer engineered for sterile pharmaceutical manufacturing environments. It operates on the principle of lyophilization — a low-temperature, high-vacuum sublimation process that removes water from frozen product matrices while preserving structural integrity, biological activity, and chemical stability. Designed specifically for production-scale processing of thermolabile biologics, APIs, herbal extracts, and sterile drug products, the system features an in-situ cleaning (CIP) capability to eliminate manual disassembly and reduce cross-contamination risk between batches. Its 5 m² shelf area supports batch capacities up to several hundred kilograms of frozen material, making it suitable for clinical trial supply manufacturing and commercial-scale lyophilization under validated conditions.
Key Features
- Stainless steel chamber constructed from AISI 304 stainless steel with fully polished, radius-rounded internal corners and electropolished welds — minimizing microbial harborage and enabling effective CIP validation.
- Uniformly heat-treated shelves manufactured without localized welding stress, ensuring ±0.5 °C temperature uniformity across all shelf surfaces during primary and secondary drying phases.
- Circulating low-viscosity silicone oil thermal fluid system optimized for stable temperature control at extremes down to –75 °C, supporting consistent heat transfer during freezing and controlled ramping during drying.
- High-efficiency condenser rated for 105 kg ice capture per 24 hours, equipped with dual-stage cascade refrigeration to maintain ≤ –75 °C operating temperature under full-load conditions.
- Hydraulic or manual stoppering mechanism integrated into the chamber lid, enabling aseptic vial sealing under vacuum or inert gas (N₂/Ar) backfill — compliant with ICH Q5C and USP <1211> requirements for sterile closure.
- Programmable Logic Controller (PLC)-based automation platform with HMI interface, supporting recipe storage, real-time parameter logging, alarm management, and audit-trail-enabled operation per FDA 21 CFR Part 11.
Sample Compatibility & Compliance
The TF-LYO-5 CIP accommodates a broad spectrum of pharmaceutical formulations including monoclonal antibodies, recombinant proteins, vaccines, small-molecule APIs, botanical concentrates, and diagnostic reagents. Its design conforms to current Good Manufacturing Practice (cGMP) standards as defined by WHO TRS 986, EU Annex 1, and US FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing. All wetted surfaces are certified to ASME BPE-2021 surface finish specifications (Ra ≤ 0.4 µm), and the system supports full qualification documentation — including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols. Optional SIP (Steam-in-Place) integration is available for terminal sterilization of the chamber and condenser.
Software & Data Management
The embedded PLC control system records time-stamped, user-identifiable data for all critical process parameters: shelf temperature, chamber pressure, condenser temperature, vacuum rate, and elapsed cycle time. Data export is supported via USB and Ethernet interfaces in CSV and PDF formats. The software architecture incorporates electronic signature functionality, role-based access control, and automated backup to external NAS or cloud storage. All data handling complies with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) and supports regulatory submissions for EMA, PMDA, and FDA review. Historical batch records are retained for ≥ 15 years as required under GxP archival guidelines.
Applications
- Commercial-scale lyophilization of injectable biologics and sterile powders for reconstitution.
- Clinical supply manufacturing for Phase II–III trials requiring strict batch traceability and environmental monitoring.
- Drying of sensitive herbal active ingredients and nutraceutical formulations where oxidative degradation must be minimized.
- Processing of diagnostic kits, enzyme preparations, and cell therapy intermediates requiring residual moisture levels below 1.5 % w/w.
- Contract manufacturing organization (CMO) infrastructure supporting multi-product campaigns with rapid changeover via CIP validation.
FAQ
Does the TF-LYO-5 CIP support both vacuum and nitrogen backfill stoppering?
Yes — the system includes configurable gas inlet manifolds for vacuum stoppering, nitrogen purge stoppering, or argon-assisted sealing, with programmable pressure ramping profiles.
Is the PLC system compliant with FDA 21 CFR Part 11?
Yes — electronic signatures, audit trails, and user permission hierarchies are fully implemented and validated per Part 11 Annex A guidance.
Can the system be qualified for GMP production use?
Yes — Tianfeng provides IQ/OQ/PQ documentation templates and supports third-party qualification execution by certified validation partners.
What is the typical validation timeline for installation and commissioning?
Standard commissioning and FAT/SAT execution require 6–8 weeks following mechanical completion, depending on site utility readiness and protocol scope.
Are spare parts and technical support available globally?
Yes — Tianfeng maintains regional service hubs in Singapore, Germany, and the United States, with 48-hour response SLAs for critical spares and remote diagnostics support.
