Scientz SCIENTZ-18N/B Stoppering Benchtop Freeze Dryer
| Brand | Scientz |
|---|---|
| Origin | Zhejiang, China |
| Manufacturer Type | Direct Manufacturer |
| Product Category | Domestic |
| Model | SCIENTZ-18N/B Stoppering Type |
| Instrument Type | Stoppering Freeze Dryer |
| Application Scope | Laboratory Use |
| Lyophilization Area | 0.09 m² |
| Ultimate Vacuum | ≤5 Pa (at no-load) |
| Condensate Capacity | 6 kg/24 h |
| Cold Trap Temperature | ≤−56 °C (at no-load) |
| Main Unit Dimensions | 670(L) × 525(W) × 910(H) + 480 mm |
Overview
The Scientz SCIENTZ-18N/B Stoppering Benchtop Freeze Dryer is an engineered solution for laboratory-scale lyophilization of thermolabile biological and pharmaceutical materials. Operating on the fundamental principle of sublimation—where ice transitions directly from solid to vapor phase under deep vacuum conditions below the triple point of water (0.01 °C, 611 Pa)—this system enables gentle, low-temperature dehydration while preserving structural integrity, bioactivity, and chemical stability of sensitive samples. Designed specifically for stoppered vial processing, it integrates a manual hydraulic or mechanical stoppering mechanism post-primary drying, enabling hermetic sealing under controlled inert atmosphere (via optional N₂ or argon purge), thereby eliminating secondary moisture uptake during handling and storage. Its compact footprint, robust thermal management architecture, and compliance-ready control framework make it suitable for R&D labs, QC/QA units, and pilot-scale process development environments aligned with GLP, ISO 13485, and FDA 21 CFR Part 11 data integrity requirements.
Key Features
- High-efficiency dual-stage refrigeration system utilizing internationally certified Secop (formerly Danfoss) compressors, delivering rapid cooldown and stable cold trap temperatures ≤−56 °C at no-load—optimized for efficient water vapor condensation and minimal thermal load on sample shelves.
- 7-inch full-color TFT resistive touchscreen interface with embedded industrial ARM9 core controller (32 MB RAM / 128 MB Flash), supporting intuitive parameter configuration, real-time monitoring, and responsive multi-task operation.
- Transparent one-piece polycarbonate drying chamber—chemically resistant, impact-tough, and optically clear—enabling unobstructed visual observation of ice sublimation, cake formation, and collapse behavior throughout the entire lyophilization cycle.
- Integrated data logging system automatically records time-stamped temperature (shelf, cold trap, product), pressure, and valve status; stores ≥1,000 complete freeze-drying cycles locally; supports USB export for offline analysis using Scientz’s proprietary PC-based LyoView software.
- KF-25 quick-connect vacuum interface ensures leak-tight, tool-free coupling with external vacuum pumps; includes programmable vacuum pump start delay logic—activated only after cold trap reaches user-defined threshold (e.g., −40 °C), extending pump service life and minimizing oil backstreaming risk.
- Manual stoppering actuation mechanism compatible with standard 20 mm and 22 mm serum vials (up to 184× Φ22 mm per batch); optional inert gas inlet valve allows controlled backfilling to ≤0.5 mbar prior to stopper compression, preventing oxidation and moisture reabsorption.
Sample Compatibility & Compliance
The SCIENTZ-18N/B accommodates diverse sample formats including bulk solutions (up to 1 L per cycle), stacked trays (Φ200 mm × 3 shelf layers, 70 mm spacing), and individual vials (990× Φ12 mm, 349× Φ16 mm, or 184× Φ22 mm). It supports lyophilization of vaccines, monoclonal antibodies, enzymes, probiotics, tissue extracts, and diagnostic reagents—materials whose conformational fidelity depends critically on controlled ice nucleation, primary drying rate, and residual moisture content (<1–3% w/w). The system meets baseline mechanical and electrical safety standards per IEC 61010-1. While not pre-certified to ISO 22042 or ASTM F2476, its architecture—including audit-trail-capable software logs, user-access controls, and electronic signature support via LyoView—facilitates alignment with GMP Annex 1, USP , and EU GDP guidelines when deployed within validated workflows.
Software & Data Management
LyoView desktop software (Windows-compatible) imports .csv or proprietary binary logs exported via USB drive. It enables overlay comparison of multiple cycles, derivative analysis of drying rate profiles, identification of critical transition points (e.g., end of primary drying), and generation of PDF reports compliant with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available). All data files include embedded metadata: operator ID, timestamp, instrument serial number, and version-controlled firmware build ID. Optional 21 CFR Part 11 module provides role-based access levels, electronic signatures, and immutable audit trails for regulated environments.
Applications
- Routine stabilization of lab-prepared biologics prior to long-term cryostorage or transport.
- Process parameter scouting for scalable lyophilization protocols—mapping collapse temperature (Tc’), eutectic melt onset (Teu), and optimal shelf ramp rates.
- Stability testing of new drug candidates under accelerated aging conditions (ICH Q1A–Q5C).
- Preparation of reference standards and calibration materials requiring traceable moisture content and morphological consistency.
- Preservation of microbial cultures, fungal spores, and plant protoplasts without cryoprotectant-induced stress.
FAQ
What is the maximum batch capacity for vials in the SCIENTZ-18N/B?
Up to 184 vials of 22 mm diameter, or 349 vials of 16 mm diameter, or 990 vials of 12 mm diameter—configured across three removable stainless-steel shelves.
Does the system support automated pressure rise tests (PRT) or TDLAS-based moisture monitoring?
No—these are advanced features available only on high-end industrial systems; the SCIENTZ-18N/B relies on conventional thermocouple-based product temperature estimation and Pirani/capacitance manometry for vacuum feedback.
Can the cold trap temperature be set to −80 °C on this model?
The base SCIENTZ-18N/B achieves ≤−56 °C; the −80 °C variant is a separate configuration (SCIENTZ-18N/B-80) with dual-compressor cascade refrigeration and extended cabinet height.
Is the touch screen interface validated for 21 CFR Part 11 compliance?
The hardware itself is not individually validated; however, when used with LyoView’s optional Part 11 package—including electronic signatures, audit trail export, and password-protected configuration locks—it supports implementation within a site-specific computerized system validation (CSV) framework.
What vacuum pump compatibility is recommended?
KF-25 flanged two-stage oil-sealed rotary vane pumps (e.g., Edwards RV8, Agilent TWISTRA 10, or Leybold DRA 10) with ultimate vacuum ≤1×10⁻² Pa and pumping speed ≥8 m³/h are strongly advised for optimal primary drying performance.
