Scientz SCIENTZ-10N/D Manifold-Type Bell-Jar Freeze Dryer with Stoppering Capability
| Brand | Scientz |
|---|---|
| Origin | Zhejiang, China |
| Manufacturer Type | Direct Manufacturer |
| Instrument Type | Manifold-Style Stoppering Freeze Dryer |
| Application | Laboratory-Scale Lyophilization |
| Shelf Area | 0.08 m² |
| Ultimate Vacuum (No Load) | ≤5 Pa |
| Condensate Capacity (24 h) | 3 kg/batch |
| Cold Trap Temperature (No Load) | ≤−56 °C |
| Dimensions (L×W×H + Height of Bell Jar) | 590 × 460 × 450 mm + 440 mm |
Overview
The Scientz SCIENTZ-10N/D is a compact, manifold-type bell-jar freeze dryer engineered for precise, reproducible lyophilization of small-to-medium batch samples in academic, governmental, and biopharmaceutical laboratories. It operates on the principle of sublimation under deep vacuum: frozen aqueous or solvent-based samples are dried directly from solid to vapor phase without passing through liquid state—preserving labile biomolecular structures, enzymatic activity, thermal sensitivity, and morphological integrity. This process ensures minimal denaturation of proteins, nucleic acids, vaccines, microbial cultures, and heat-sensitive pharmaceuticals. The system integrates a high-efficiency dual-stage refrigeration architecture, enabling stable cold trap operation at ≤−56 °C (standard) or optionally −80 °C via cascaded compressor configuration—critical for low-eutectic-point formulations and volatile solvent removal. Its modular bell-jar design supports simultaneous drying of up to eight vials via standard 24/29 or 29/32 neck ports, while the integrated stoppering mechanism allows in-situ sealing under vacuum—a prerequisite for sterile, moisture-sensitive final product handling per USP and FDA 21 CFR Part 211 requirements.
Key Features
- Compact footprint (590 × 460 × 450 mm base + 440 mm bell jar height) optimized for space-constrained labs without compromising condensation capacity (3 kg/batch)
- Imported high-reliability compressors delivering rapid cooldown and sustained cold trap stability at ≤−56 °C (no load); optional −80 °C cascade system available for demanding applications
- 7-inch true-color capacitive touchscreen with industrial-grade embedded OS; real-time display of cold trap temperature, chamber pressure, sample thermocouple readings (optional), and shelf temperature (if equipped)
- Automated data logging: freeze-drying profiles stored internally with timestamping; exportable via USB to PC for GLP-compliant audit trails and 21 CFR Part 11–compatible review
- Optically transparent, one-piece polycarbonate bell jar—chemically resistant, impact-tough, and fully sealable; enables full visual monitoring of ice sublimation, cake formation, and collapse events
- Intelligent vacuum management: programmable vacuum pump activation threshold (e.g., pump engages only after cold trap reaches −45 °C), preventing oil backstreaming and extending pump service life
- Standard inclusion of inert gas inlet valve (N₂ or Ar compatible) for controlled backfilling and oxygen-sensitive sample handling
Sample Compatibility & Compliance
The SCIENTZ-10N/D accommodates diverse sample formats—including serum vials (10–50 mL), microbiological culture tubes, plant tissue sections, soil/sediment aliquots, and nanoparticle suspensions—without requiring shelf heating or complex tray configurations. Its open manifold architecture eliminates cross-contamination risks inherent in shared shelf systems. Regulatory alignment includes support for ISO 22000 (food safety), ISO 13485 (medical device manufacturing), and ICH Q5C (biopharmaceutical stability). When operated with validated protocols and calibrated thermocouples, it meets the lyophilization validation prerequisites outlined in EU Annex 15 and USP . Optional eutectic point detection module enables empirical determination of primary drying endpoints, enhancing process robustness across variable formulations.
Software & Data Management
The embedded control firmware records all critical process parameters at user-defined intervals (default: 10 s), storing ≥10,000 data points per cycle. Historical batches are searchable by date, operator ID, or custom tag. USB export generates CSV files compatible with MATLAB, Python Pandas, or commercial LIMS platforms. Optional PC-based software provides advanced curve overlay analysis, deviation alerts, and automated report generation compliant with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available). Audit trail functionality logs all parameter modifications, user logins, and system events—fully traceable for FDA inspection readiness.
Applications
- Academic research: lyophilization of bacterial/viral stocks (ATCC, DSMZ), monoclonal antibodies, CRISPR-Cas complexes, and extracellular vesicles
- Pharmaceutical development: formulation screening of lyo-protectants, stability testing of peptide APIs, and pilot-scale production of oral disintegrating tablets (ODTs)
- Food & agriculture: preservation of probiotics, enzyme powders, fruit extracts, and botanical reference standards
- Environmental analysis: dehydration of soil, sludge, and water filter membranes prior to heavy metal or organic contaminant quantification (EPA Method 3540C)
- Clinical diagnostics: preparation of ELISA kit reagents, PCR master mixes, and reference standards for molecular pathology labs
FAQ
What is the maximum batch size supported by the SCIENTZ-10N/D?
Up to 3 kg of frozen material per cycle, assuming optimal ice distribution and sublimation kinetics across the 0.08 m² effective surface area.
Can the system perform in-situ stoppering under vacuum?
Yes—the integrated hydraulic or pneumatic stoppering actuator enables automatic vial sealing post-primary drying, eliminating exposure to ambient humidity.
Is the cold trap temperature verified and traceable to NIST standards?
Calibration certificates for the PT100 sensor are provided upon request; field verification using certified dry-well calibrators is supported per ISO/IEC 17025 guidelines.
Does the system comply with 21 CFR Part 11 for electronic records?
When used with enabled audit trail, password-protected user roles, and electronic signature modules (optional), it satisfies core Part 11 requirements for record integrity and accountability.
What vacuum pump options are compatible?
Dual-stage oil-sealed rotary vane pumps (e.g., Edwards RV8, Leybold DuraVac), dry scroll pumps (e.g., Agilent IDP-10), and optional oil mist filters or automatic differential valves for extended pump longevity.
