SCIENTZ SCIENTZ-18N/C Manifold-Type Laboratory Benchtop Freeze Dryer
| Brand | SCIENTZ |
|---|---|
| Origin | Zhejiang, China |
| Manufacturer Type | Direct Manufacturer |
| Instrument Type | Manifold-Type Freeze Dryer |
| Application | Laboratory Use |
| Lyophilization Area | 0.18 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 (L×W×H) | 670 × 525 × 910 mm + 480 mm (height with condenser column) |
Overview
The SCIENTZ SCIENTZ-18N/C is a manifold-type benchtop freeze dryer engineered for precise, reproducible lyophilization of heat-labile biological and pharmaceutical samples in research and development laboratories. It operates on the fundamental principle of sublimation—removing water from frozen samples under deep vacuum conditions below the triple point of water (0.01 °C, 611 Pa), thereby preserving structural integrity, enzymatic activity, and immunogenicity of sensitive biomolecules. Unlike shelf-based (contact-heated) systems, the SCIENTZ-18N/C employs a dedicated cold trap and manifold configuration to isolate individual sample vials or flasks, enabling independent processing of multiple heterogeneous samples without cross-contamination. Its design prioritizes thermal stability, vacuum integrity, and operational transparency—critical for method development, stability studies, and pre-formulation trials compliant with ICH Q5C and USP . The system is not intended for GMP production but serves as a validated platform for process parameter optimization prior to scale-up.
Key Features
- High-efficiency refrigeration system utilizing a globally certified Secop (formerly Danfoss) compressor, delivering rapid cooldown and stable cold trap performance at ≤−56 °C (no-load).
- 7-inch full-color capacitive touchscreen interface running an industrial-grade embedded OS (ARM9 core, 32 MB RAM / 128 MB FLASH), supporting real-time data logging, multi-curve overlay, and intuitive protocol navigation.
- Optically transparent polycarbonate drying chamber—single-piece injection-molded, chemically resistant, shatter-resistant, and fully sealable—enabling unobstructed visual monitoring of ice sublimation, cake formation, and collapse events.
- KF-25 quick-connect vacuum interface between main unit and external pump ensures leak-tight coupling, simplifies maintenance, and complies with ISO-KF vacuum standard practices.
- Programmable cold trap temperature interlock: vacuum pump activation is automatically delayed until trap reaches user-defined setpoint (e.g., −45 °C), minimizing oil backstreaming and extending pump service life.
- Integrated inert gas purge valve (N₂ or Ar compatible) allows controlled repressurization post-drying to prevent oxidation of labile compounds.
- Onboard storage for ≥100 complete lyophilization cycles; data export via USB flash drive for offline analysis using SCIENTZ’s PC-based LyoView software (supports CSV, PDF report generation, curve comparison, and audit trail export).
Sample Compatibility & Compliance
The SCIENTZ-18N/C accommodates eight standard 24/29 mm O-ring–sealed manifold ports, each accepting internationally compatible lyophilization flasks (e.g., 100–500 mL round-bottom or pear-shaped) or screw-threaded vials with stopper-compatible adapters. Standard configuration includes eight 24 mm neck flasks; optional wide-mouth manifold adapters support Φ12 mm, Φ16 mm, and Φ22 mm serum vials (capacity: 1320 / 698 / 360 units respectively). Solution loading capacity per batch is up to 2 L across four removable stainless-steel shelves (Φ240 mm, 70 mm spacing). All wetted surfaces are electropolished 316L stainless steel or USP Class VI-certified polymers. While not 21 CFR Part 11–validated out-of-the-box, the system supports GLP-aligned documentation when used with timestamped, password-protected cycle logs and exported traceable datasets—suitable for internal R&D audits and regulatory submission preparatory work (e.g., FDA IND-enabling studies).
Software & Data Management
LyoView PC software (Windows 10/11 compatible) provides comprehensive post-processing functionality: overlay of multiple drying curves (chamber pressure, cold trap temp, product thermocouple), derivative analysis of primary drying endpoints, and customizable reporting templates aligned with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate). Cycle files include metadata (operator ID, date/time stamp, ambient conditions), raw sensor values sampled at 1 Hz, and event markers (valve actuation, alarm triggers). USB-exported logs retain cryptographic hash integrity; no cloud upload or remote access is enabled by default—ensuring data sovereignty per GDPR and HIPAA-aligned institutional policies.
Applications
This system is routinely deployed for: (1) stabilization of monoclonal antibodies, viral vectors, and mRNA-LNPs during preclinical formulation screening; (2) long-term preservation of bacterial/fungal cultures and primary cell lines without cryoprotectant-induced stress; (3) preparation of calibration standards for LC-MS bioanalysis; (4) dehydration of botanical extracts and enzyme preparations where thermal degradation must be avoided; and (5) feasibility testing of novel excipient systems (e.g., trehalose/sucrose blends) under variable ramp-rate and annealing protocols. Its manifold architecture makes it especially suitable for parallel screening of multiple candidate formulations under identical vacuum and temperature profiles.
FAQ
What is the maximum batch volume supported by the SCIENTZ-18N/C?
Up to 2 liters of aqueous solution can be processed uniformly across four shelves—or distributed among eight flasks connected via the manifold ports.
Does the system include a vacuum pump?
No. An external vacuum pump (e.g., dual-stage rotary vane or dry scroll type) must be selected separately and connected via KF-25 fittings.
Can the cold trap temperature be monitored in real time during operation?
Yes. A calibrated Pt100 sensor continuously measures cold trap surface temperature, displayed numerically and graphically on the touchscreen and logged with all other parameters.
Is the SCIENTZ-18N/C compliant with ISO 22042 or ASTM F2476?
It meets key functional requirements of ASTM F2476 (Standard Guide for Lyophilization Process Development) for laboratory-scale equipment, including vacuum stability, temperature uniformity verification, and data recording fidelity—but formal certification requires third-party validation per user-defined IQ/OQ protocols.
What optional accessories enhance process control?
Available upgrades include: eutectic point measurement module (for empirical determination of optimal shelf temperature), vacuum regulation valve (to maintain dynamic pressure setpoints during primary drying), and electrothermal defrost system (reducing manual defrost time by >60%).
