English Product Name

Overview

The Jihepu ZLGJ-18 Manifold-Type Stoppering Vacuum Freeze Dryer is a laboratory-scale lyophilization system engineered for reproducible, controlled freeze drying of heat-sensitive biologicals, pharmaceuticals, and analytical standards. It operates on the principle of sublimation under deep vacuum: frozen samples are dried by removing ice directly from the solid to vapor phase without passing through liquid—preserving structural integrity, activity, and stability. Unlike shelf-based systems, the ZLGJ-18 integrates a multi-port manifold with stoppering capability, enabling simultaneous drying of multiple vials or flasks while allowing post-drying sterile sealing under vacuum. Its integrated condenser (-55 °C standard, optional -80 °C) ensures efficient water vapor capture during primary and secondary drying stages, supporting batch processing of up to 6 kg of ice over 24 hours. Designed for GLP-compliant environments, the unit features inert-contact materials, modular control architecture, and full traceability of process parameters—making it suitable for method development, QC release testing, and small-batch production in regulated laboratories.

Key Features

• Monolithic stainless steel construction: Condenser chamber and drying manifold are fabricated from electropolished 304 stainless steel—corrosion-resistant, non-porous, and compliant with ISO 14644-1 Class 5 cleanroom surface requirements.
• Patented gas-flow optimization: Engineered internal baffle geometry ensures uniform vapor distribution across the condenser surface, maximizing ice capture efficiency and minimizing re-deposition risk.
• Integrated pre-freezing capability: The condenser doubles as a freezing platform—eliminating the need for external ultra-low temperature freezers prior to loading.
• Intelligent vacuum management: Vacuum pump activation is thermally interlocked; the system delays pump start until condenser temperature reaches ≤−40 °C, preventing oil backstreaming and extending pump service life.
• Industrial-grade control interface: 7-inch capacitive touchscreen running SH-HPSC-II embedded controller—supporting PID-regulated shelf/manifold temperature profiles, real-time alarm logging, and password-protected user role assignment (Operator, Technician, Administrator).
• Comprehensive sensor calibration suite: Onboard calibration routines for PT100 temperature sensors and Pirani vacuum transducers—traceable to NIST standards via user-accessible offset adjustment.

Sample Compatibility & Compliance

The ZLGJ-18 accommodates diverse sample formats via its 8-port manifold: two each of 100 mL, 150 mL, 250 mL, and 500 mL round-bottom flasks; three φ200 mm stainless steel trays (for bulk powder or serum); and direct compatibility with standard pharmaceutical vials (990 × φ12 mm, 555 × φ16 mm, or 360 × φ22 mm). All wetted surfaces contact only 316L stainless steel or FDA-listed fluoropolymers (e.g., PTFE O-rings), satisfying USP , ISO 10993-5, and EU Annex 1 material compatibility criteria. The system supports audit-ready operation per 21 CFR Part 11 when paired with validated data export workflows—electronic signatures, immutable event logs, and revision-controlled parameter sets are fully implementable through its embedded controller firmware.

Software & Data Management

Process data—including condenser temperature, manifold pressure, and optional sample thermocouple readings—are sampled at 1-second intervals and stored internally for ≥30 days. Export is supported via USB 2.0 to CSV or XML format, preserving time-stamped metadata (start/end timestamps, operator ID, method name). Third-party integration (e.g., LabVantage, Empower) is enabled via Modbus TCP protocol. All data files include SHA-256 checksums for integrity verification. Audit trails record every parameter change, login/logout event, and calibration action—with tamper-evident timestamps synchronized to NTP servers. Raw data files are write-once/read-many (WORM) by default, aligning with ALCOA+ principles for GxP-regulated environments.

Applications

• Pharmaceutical R&D: Lyophilization cycle development for monoclonal antibodies, vaccines, and peptide APIs—particularly where stoppering under vacuum is required to maintain headspace inertness.
• Biological sample banking: Long-term stabilization of bacterial cultures, plasmid DNA, and enzyme preparations without cryoprotectant-induced denaturation.
• Environmental & food testing labs: Preparation of reference standards for GC-MS or ICP-MS analysis—minimizing matrix volatility loss and isotopic fractionation.
• Academic research: Structural preservation of nanomaterials, hydrogels, and porous scaffolds for SEM imaging or BET surface area analysis.
• QC/QA release testing: Final moisture content validation per USP <<751> and Ph. Eur. 2.9.32—supported by integrated gravimetric endpoint detection via optional balance interface.

FAQ

Does the ZLGJ-18 support automated stoppering after drying?

Yes—the manifold includes a mechanical stoppering actuator compatible with standard rubber stoppers and aluminum crimp seals, activated manually or via programmable timer after vacuum hold completion.

Can the condenser temperature be set to −80 °C without hardware modification?

No—the −80 °C option requires factory-installed dual-stage cascade refrigeration; field upgrade is not supported. Units shipped with −55 °C condensers cannot be retrofitted.

Is the vacuum pump included in the base configuration?

Yes—a certified two-stage rotary vane pump (4 L/s nominal speed, ultimate vacuum ≤1 Pa) is supplied as standard equipment, pre-connected and vibration-isolated.

What regulatory documentation is provided for GMP validation?

Factory test reports (FAT), IQ/OQ protocols (user-executable), material compliance certificates (RoHS, REACH), and 3.1 material test reports for all stainless steel components are included with shipment.

How is ambient humidity managed during operation?

The system requires ambient RH ≤70% during operation; no internal dehumidification is provided. In high-humidity environments, installation in an air-conditioned lab with dedicated exhaust ventilation is mandatory to prevent condenser frosting and vacuum instability.