Ningbo Scientz SCIENTZ-10YG/B Pilot-Scale In-Situ Freeze Dryer with Silicone Oil Heating System

Overview

The Ningbo Scientz SCIENTZ-10YG/B is a pilot-scale, in-situ freeze dryer engineered for reproducible, controllable lyophilization of temperature-sensitive biological, pharmaceutical, food, and environmental samples. It operates on the fundamental principles of sublimation under vacuum: frozen water is removed directly from the solid to vapor phase without passing through liquid, preserving structural integrity, bioactivity, and chemical stability. Unlike conventional air-heated or electric-resistance heated systems, the SCIENTZ-10YG/B employs a closed-loop silicone oil circulation system for precise thermal management of the shelf stack — enabling uniform heat transfer during primary and secondary drying stages. This architecture supports rigorous process development, scale-up studies, and compliance-critical workflows where batch consistency, thermal homogeneity (±3 °C across shelves), and full parameter traceability are mandatory. Its integrated cold trap and drying chamber reduce footprint while maintaining separation integrity between condensation and product zones — ideal for laboratories requiring flexible, small-to-medium batch processing (up to 0.21 m² active shelf area) without industrial infrastructure.

Key Features

• Shelf-based in-situ freezing and drying with silicone oil heating/cooling — eliminates manual tray transfer and ensures minimal thermal shock
• Precision PID-controlled shelf temperature regulation, supporting up to 40 programmable segments per lyophilization cycle
• PLC-based control system with color touchscreen interface, real-time parameter monitoring (shelf temp, cold trap temp, chamber pressure, silicone oil temp), and multi-level user access (3-tier permission)
• Automated vacuum sequencing: vacuum pump activation delayed until cold trap reaches preset temperature — extending pump life and minimizing oil backstreaming
• Transparent polycarbonate drying chamber (one-piece molded, corrosion-resistant, high optical clarity) for full visual process observation
• Integrated data logging: all critical parameters automatically timestamped and stored internally; exportable via USB to PC for post-run analysis or regulatory reporting
• Configurable drying profiles including linear ramp, stepwise hold, and slope-controlled heating modes
• Optional accessories include inert gas (N₂) purging interface, eutectic point measurement module, −80 °C cascade refrigeration unit, external T-frame support, and remote monitoring via PC software or mobile application

Sample Compatibility & Compliance

The SCIENTZ-10YG/B accommodates diverse sample formats including vials (2–20 mL), Petri dishes, beakers, and custom trays — suitable for aqueous solutions, suspensions, emulsions, and semi-solid matrices. It meets core operational requirements for GLP-compliant research environments and pre-GMP process development. While not certified to ISO 22000 or FDA 21 CFR Part 11 out-of-the-box, its audit-ready data logging, user authentication, electronic signature support (via optional software), and full parameter traceability align with foundational elements of ALCOA+ data integrity principles. The system supports validation protocols per ASTM F2476 (Standard Guide for Validation of Freeze Drying Processes) and ICH Q5C (Quality of Biotechnological Products: Stability Testing). Applications span lyophilized bacterial cultures (e.g., Lactobacillus, Bacillus), protein formulations, nucleic acid extracts, soil/sediment matrices for environmental analysis, botanical extracts, and archival-grade paper dehydration — all requiring low-temperature, low-oxygen preservation.

Software & Data Management

The embedded control firmware records time-stamped values for shelf temperature, cold trap temperature, chamber pressure, and silicone oil loop temperature at user-defined intervals (default: 10 s). All cycles are saved with unique identifiers and metadata (operator ID, date/time, protocol name). Data exports as CSV files compatible with Excel, MATLAB, or LIMS platforms. Optional PC-based software enables advanced curve overlay, deviation analysis, and report generation (PDF/Excel) compliant with internal SOPs. Remote operation via Ethernet or Wi-Fi allows supervision from lab workstations or off-site locations — with encrypted session handling and role-based access controls. Audit trail functionality logs all configuration changes, start/stop events, and alarm acknowledgments, satisfying basic requirements for regulated environments conducting method development or stability studies.

Applications

• Pharmaceutical R&D: formulation screening of injectables, monoclonal antibodies, and mRNA-LNP complexes
• Agricultural science: preservation of plant tissue cultures, fungal spores, and seed germplasm
• Food science: development of shelf-stable functional ingredients, probiotic powders, and nutrient-retentive snacks
• Environmental testing: preparation of soil, sludge, and water filter samples for heavy metal or organic contaminant analysis (e.g., EPA Method 5035)
• Cultural heritage conservation: controlled dehydration of water-damaged manuscripts and parchment without hydrolytic degradation
• Academic research: cryopreservation of extracellular vesicles, exosomes, and synthetic polymer nanoparticles
• Diagnostic reagent manufacturing: stabilization of enzyme conjugates and antigen-coated microspheres

FAQ

What is the maximum batch capacity for this model?

The SCIENTZ-10YG/B supports up to 0.21 m² of shelf area, typically accommodating ~1.5–2.0 L total solution volume depending on container geometry and fill depth.

Does it support automated pressure rise tests (PRT) or MTM?

Not natively — but chamber pressure data is logged continuously, enabling manual PRT calculation. Optional manometric temperature measurement (MTM) sensors can be integrated via third-party probes connected to analog inputs.

Can the system operate unattended overnight?

Yes — with UPS backup (optional), alarm notifications (audible + display), and automatic shutdown on critical fault (e.g., compressor overpressure, vacuum leak >10 Pa/min).

Is the cold trap condenser accessible for defrosting?

Yes — the cold trap is front-accessible with manual drain valve; auto-defrost mode is not included but can be implemented via custom PLC logic.

What vacuum pump compatibility is recommended?

Dual-stage oil-sealed rotary vane pumps rated ≥4 m³/h pumping speed and ≤1 × 10⁻² Pa base pressure — optionally fitted with oil mist filter and automatic vacuum control valve to prevent backstreaming.