Ningbo Scientz Pharmaceutical-Grade Freeze Dryer SCIENTZ-S-(C/S)
| Brand | Ningbo Scientz |
|---|---|
| Origin | Zhejiang, China |
| Manufacturer Type | Direct Manufacturer |
| Product Category | Domestic |
| Model | SCIENTZ-S-(C/S) |
| Instrument Type | Standard Shelf-Type Freeze Dryer |
| Application Scope | Pilot-Scale |
| Lyophilization Area | 0.21 m² |
| Ultimate Vacuum (Empty Chamber) | ≤5 Pa |
| Condensate Capacity (24 h) | 4 kg/24 h |
| Cold Trap Temperature (Empty) | ≤−70 °C |
| Dimensions (L×W×H) | 750 × 640 × 1200 mm |
Overview
The Ningbo Scientz Pharmaceutical-Grade Freeze Dryer SCIENTZ-S-(C/S) is a pilot-scale, shelf-type lyophilization system engineered for reproducible, GMP-aligned freeze-drying of heat-sensitive pharmaceuticals, biologics, diagnostics, and research-grade formulations. Based on the fundamental principles of sublimation under deep vacuum and controlled thermal transfer via silicone oil–circulated shelves, this unit delivers precise, uniform drying profiles across its 0.21 m² shelf area. Designed for regulatory readiness, the SCIENTZ-S-(C/S) integrates PLC-based process logic with PID-controlled temperature regulation, enabling compliant execution of validated lyophilization cycles—including nucleation control, primary drying ramping, and secondary drying hold phases—under ISO 22042, USP , and ICH Q5C environmental monitoring contexts.
Key Features
- Integrated PLC + PID control architecture with full-color 7-inch touchscreen HMI for intuitive cycle setup, real-time parameter visualization, and event-driven alarm logging.
- Silicone oil–circulated shelf system ensuring ±1 °C temperature uniformity across all shelves—critical for batch consistency in clinical trial material production.
- Dual-mode operation: supports both manual and fully automated freeze-drying protocols, including pre-programmed multi-segment drying curves (up to 40 segments per recipe).
- Modular cold trap design operating at ≤−70 °C (empty), paired with high-capacity condensation (4 kg/24 h), minimizes ice buildup and sustains stable vacuum during extended cycles.
- Optically transparent acrylic drying chamber enables continuous visual monitoring of cake formation, collapse onset, and desiccation progression without compromising sterility integrity.
- Comprehensive hardware protection logic: delayed compressor startup, vacuum pump interlock, and pressure-sensing shutdown prevent mechanical stress and extend service life.
- Optional inert gas backfill valve (N₂ or Ar) integrated into the chamber exhaust path for oxygen-sensitive APIs and sterile powder handling.
Sample Compatibility & Compliance
The SCIENTZ-S-(C/S) accommodates vials (2R–50R), trays, and bulk containers containing liquid, semi-solid (e.g., gels, suspensions), or pre-frozen solid matrices. Its structural design meets ASME BPVC Section VIII Div. 1 pressure boundary requirements for vacuum chambers and complies with CE Machinery Directive 2006/42/EC. When equipped with CIP/SIP modules, the system supports validation per ASTM E2500-23 (User Requirement Specification) and EU Annex 15 guidelines. Optional O-RABS or isolator integration enables Grade A environments per ISO 14644-1 Class 5 conditions. All firmware logs are time-stamped and tamper-resistant—supporting 21 CFR Part 11 audit trail requirements when used with validated upper-level software.
Software & Data Management
Process data—including shelf temperature, chamber pressure, condenser temperature, and elapsed time—is continuously recorded at user-defined intervals (1–60 s). Raw datasets export via USB to standard CSV format, compatible with third-party analysis tools (e.g., MATLAB, JMP, Unscrambler). The optional Scientz LyoControl™ PC software provides graphical curve overlay, deviation alerts, comparative batch trending, and PDF report generation with digital signature fields. All stored cycles include metadata tags (operator ID, lot number, revision date) to fulfill GLP/GMP traceability mandates.
Applications
- Clinical-phase drug substance and product lyophilization (Phase I–III)
- Stabilization of monoclonal antibodies, mRNA-LNPs, viral vectors, and enzyme conjugates
- Preparation of reference standards and QC calibration materials
- Development of lyophilized excipient blends and co-lyophilized formulations
- Scale-down modeling for commercial freeze dryer qualification (QbD-based process characterization)
- Academic and contract research organization (CRO) lyophilization feasibility studies
FAQ
What regulatory documentation is provided with the SCIENTZ-S-(C/S)?
Factory acceptance test (FAT) reports, IQ/OQ protocol templates, material certifications (3.1 EN 10204), and CE Declaration of Conformity are supplied standard. DQ documentation support is available upon request.
Can the system be validated for GMP manufacturing?
Yes—when configured with CIP/SIP, electronic signatures, audit trails, and calibrated sensors traceable to NIST standards, it meets FDA and EMA expectations for Phase III and commercial lot release.
Is remote monitoring supported out-of-the-box?
The embedded Ethernet port enables Modbus TCP communication; optional Scientz CloudLink™ gateway adds secure HTTPS-based remote access with role-based permissions and TLS 1.2 encryption.
What maintenance intervals are recommended for critical components?
Vacuum pump oil change every 500 operational hours; cold trap defrosting after each 3–5 cycles; annual calibration of pressure transducers and PT100 shelf sensors by accredited metrology lab.
Does the system support PAT integration?
Yes—RS-485 and analog 4–20 mA outputs allow connection to external NIR probes, tunable diode laser (TDL) moisture analyzers, or manometric temperature measurement (MTM) systems for real-time endpoint detection.
