CREATRUST CTFD-20/50/100/200 Pilot-Scale In-Situ Freeze Dryer

Overview

The CREATRUST CTFD-20/50/100/200 series represents a line of pilot-scale, in-situ freeze dryers engineered for process development and small-batch manufacturing in regulated environments. These systems implement primary drying via sublimation under vacuum, with secondary drying enabled by controlled shelf heating—principles aligned with ICH Q5C and USP guidelines for lyophilization. Unlike benchtop units, the CTFD series integrates full in-situ freezing, drying, and stoppering within a single chamber, eliminating manual transfer and minimizing bioburden risk. The design follows ISO 13485-aligned mechanical architecture, featuring all-stainless-steel (AISI 304/316L) contact surfaces, passivated internal welds, and Class 100,000 cleanroom-compatible construction. Each unit operates under programmable vacuum control (<10 Pa base pressure), enabling precise regulation of mass transfer kinetics during both freezing and drying phases—critical for preserving protein conformation, microbial viability, or botanical matrix integrity.

Key Features

• In-situ freezing and drying: Eliminates inter-stage material handling; reduces contamination risk per FDA Guidance for Industry: Lyophilization Process Validation (2023).
• Silicone oil-heated/cooled shelves: ±1 °C uniformity across shelf surface; temperature range −50 to +70 °C; individual shelf-mounted PT100 sensors enable layer-specific thermal profiling.
• −80 °C cold trap with high-capacity condenser: Optimized for water vapor load up to 40 kg/24 h (CTFD-200T); dual-stage refrigeration circuit with imported hermetic compressors and proprietary low-temperature lubricant ensures stable operation from −40 to +45 °C ambient.
• Structural separation of drying chamber and cold trap: Enhances ice entrapment efficiency and shortens cycle time without compromising vacuum integrity.
• 7-inch color touchscreen HMI: Intuitive interface supporting real-time graphical display of shelf temperature, chamber pressure, condenser temperature, and vacuum rate; compliant with IEC 62443-3-3 for industrial control system security.
• Automated defrost cycle with drain valve: Scheduled or on-demand; prevents ice buildup without manual intervention or system shutdown.
• Optional eutectic point detection module: Enables empirical determination of collapse temperature (T_c) and optimal primary drying shelf setpoint per ASTM F2951-21.

Sample Compatibility & Compliance

The CTFD series accommodates vials (12 mm, 16 mm, 22 mm), trays (up to 900 × 600 mm), and custom containers compatible with pharmaceutical, nutraceutical, and botanical matrices. Shelf configurations support liquid loading volumes from 4.5 L (CTFD-20S) to 40 L (CTFD-200T). All wetted parts meet USP Class VI biocompatibility standards. System validation documentation supports IQ/OQ protocols per GAMP 5, and data integrity complies with FDA 21 CFR Part 11 requirements—including electronic signatures, audit trails, and immutable storage of all process parameters on FAT32-formatted internal memory (≥30 days of continuous logging). Optional external freeze-drying flask ports accommodate rotary evaporation integration for hybrid dehydration workflows.

Software & Data Management

Embedded firmware supports up to 36 customizable freeze-drying programs, each containing up to 40 discrete temperature/pressure/time segments. Data is timestamped and stored with millisecond resolution. USB 2.0 port enables direct export of CSV-formatted logs to encrypted USB drives—compatible with LIMS integration (e.g., LabWare, STARLIMS). Historical trend analysis includes derivative curves (dT/dt, dP/dt) for critical phase transition identification. Optional Ethernet connectivity supports remote monitoring via Modbus TCP or OPC UA, facilitating centralized fleet management in multi-unit pilot facilities.

Applications

• Pharmaceutical process development: Formulation screening, cycle optimization, and stability batch production under cGMP-compliant conditions.
• Biologics and vaccine manufacturing: Preservation of monoclonal antibodies, viral vectors, and lyophilized cell therapies requiring strict thermal history control.
• Functional food R&D: Stabilization of probiotics, enzymes, and heat-labile phytochemicals without solvent residues.
• Traditional Chinese medicine (TCM) processing: Low-temperature dehydration of volatile-oil-rich herbs while retaining terpenoid profiles and antioxidant activity.
• Academic and contract research: Reproducible scale-up from lab-scale (≤2 L) to pilot-scale (≤40 L) with linearly scalable shelf area and condensation capacity.

FAQ

What regulatory standards does the CTFD series support?
It supports compliance with FDA 21 CFR Part 11, EU Annex 11, ISO 13485, and ICH Q5C through validated firmware, audit-trail-enabled data logging, and GAMP 5-aligned qualification packages.
Can the system be integrated into an existing SCADA or MES platform?
Yes—via optional Ethernet interface with Modbus TCP or OPC UA protocol support for real-time parameter streaming and alarm forwarding.
Is the cold trap designed for continuous operation during extended cycles?
Yes—the dual-stage refrigeration system maintains ≤−75 °C condenser temperature under sustained 95% ice load, verified per ASTM F2476-22 test protocol.
How is shelf temperature uniformity validated?
Each unit ships with a factory-calibrated 9-point thermocouple mapping report (per ISO 14644-3), confirming ≤±1.0 °C deviation across full shelf surface at −30 °C and +25 °C setpoints.
What maintenance intervals are recommended for the refrigeration system?
Compressor oil and dryer filter replacement every 12 months or 4,000 operating hours—whichever occurs first—using only OEM-specified lubricant and molecular sieve desiccant.