Jihepu ZLGJ-12 Stoppering Vacuum Freeze Dryer

Overview

The Jihepu ZLGJ-12 Stoppering Vacuum Freeze Dryer is a compact, integrated laboratory-scale lyophilization system engineered for reproducible, GMP-aligned primary drying of heat-sensitive biopharmaceuticals, diagnostics, and research-grade biological samples. It operates on the fundamental principle of sublimation—removing water from frozen samples under high vacuum while maintaining product integrity through precise thermal control. Unlike shelf-based freeze dryers requiring external pre-freezing, the ZLGJ-12 incorporates an integrated condenser with sample pre-freezing capability, eliminating dependency on ultra-low temperature freezers. Its stoppering function enables in-chamber vial sealing under vacuum or inert gas (e.g., nitrogen), critical for maintaining sterility and residual moisture control in final dosage forms. Designed for compliance-driven environments, the unit meets foundational requirements for GLP documentation workflows and supports audit-ready operation in academic, QC, and early-stage development labs.

Key Features

• Monolithic stainless steel construction with electropolished condenser surface and corrosion-resistant drying chamber—ensures cleanability and long-term compatibility with aqueous, buffered, and mildly acidic formulations.
• Patented gas flow path design optimizes vapor migration from shelves to condenser, enabling uniform ice deposition and maximizing condensation efficiency across the full 0.08 m² shelf area.
• High-efficiency air-cooled refrigeration system featuring an internationally certified hermetic compressor—delivers stable −55 °C condenser temperature (−80 °C optional) with low acoustic emission (<58 dB(A)) and extended service intervals.
• Industrial-grade 7-inch capacitive touchscreen interface powered by the SH-HPSC-II modular controller—supports real-time PID regulation of shelf temperature (±0.5 °C accuracy), vacuum setpoint (0.1–5 Pa range), and cycle timing with programmable ramp/soak profiles.
• Vacuum pump protection logic: automatic pump start delay until condenser reaches −40 °C, preventing oil backstreaming and extending pump life; integrated 2 L/s dual-stage rotary vane pump achieves ≤5 Pa ultimate vacuum within <30 minutes (empty chamber).
• User-accessible sensor calibration suite—including independent offset adjustment for PT100 shelf and condenser probes—ensures metrological traceability over extended operational lifetimes.
• Multi-tier access control: three configurable user roles (Operator, Technician, Administrator) with password-protected parameter editing, cycle archiving, and event log export via USB 2.0 port.

Sample Compatibility & Compliance

The ZLGJ-12 accommodates standard pharmaceutical vials (12 mm, 16 mm, and 22 mm diameters) with capacities up to 560, 285, and 165 units respectively—compatible with ISO 8362-compliant glassware and elastomeric closures. The stainless steel shelf assembly accepts three φ180 mm trays or direct vial placement with ≥100 mm inter-vial spacing to ensure unobstructed vapor flow. All wetted surfaces comply with USP Class VI biocompatibility standards and are inert toward common lyophilization excipients (e.g., sucrose, trehalose, mannitol). While not certified to ISO 13485 or FDA 21 CFR Part 11 out-of-the-box, the system’s deterministic control architecture, electronic audit trail (timestamped cycle logs, alarm history, parameter changes), and password-secured configuration support validation protocols aligned with ICH Q5C, Q5D, and EU Annex 15 requirements.

Software & Data Management

Data integrity is maintained through embedded non-volatile memory storing ≥1,000 complete lyophilization cycles with timestamps, setpoints, actual values (shelf temp, chamber pressure, condenser temp), and alarm annotations. Cycle reports export in CSV format for integration with LIMS or ELN platforms. Optional Ethernet connectivity (via RS485-to-Ethernet gateway) enables remote monitoring and centralized fleet management. Firmware updates are performed via USB without requiring factory service intervention. All calibration records, maintenance logs, and user activity entries are digitally signed and time-stamped—supporting GLP-compliant record retention per 21 CFR Part 11 Subpart B when deployed with validated IT infrastructure.

Applications

• Stabilization of monoclonal antibodies, recombinant proteins, and viral vectors prior to stability testing or formulation optimization.
• Preparation of reference standards and calibrators for clinical chemistry and immunoassay development.
• Routine drying of microbial cultures, enzymes, and nucleic acid preparations where enzymatic activity or structural fidelity must be preserved.
• Small-batch lyophilization of diagnostic reagents—including lateral flow assay components and PCR master mixes—under controlled residual moisture conditions (<1.5% w/w typical).
• Method development and cycle optimization studies supporting tech transfer to production-scale freeze dryers (e.g., mapping critical process parameters: T_shelf, P_chamber, ΔT_product).

FAQ

Does the ZLGJ-12 support automatic pressure rise test (PRT) functionality?
No—PRT is not implemented in the base firmware. However, manual hold-and-monitor sequences can be programmed using time-based vacuum hold steps and pressure trend logging.
Can the condenser temperature be independently controlled during primary drying?
Yes—the condenser operates at a fixed setpoint (−55 °C or −80 °C), but its temperature is continuously monitored and used as a safety interlock for vacuum pump activation and shelf heating limits.
Is nitrogen backfilling supported for stoppering?
The system includes a dedicated gas inlet port compatible with regulated nitrogen supply; however, automated gas purge/pressurization sequencing requires custom script integration via the controller’s I/O expansion module.
What is the maximum allowable load mass for optimal drying performance?
For consistent sublimation rates and ≤1.5% residual moisture, total loaded mass should not exceed 2.5 kg when using 3–4 kg/24 h capture capacity—accounting for thermal mass and vapor diffusion constraints.
Are IQ/OQ documentation templates available from the manufacturer?
Jihepu provides basic installation and operational qualification checklists; full GxP-compliant protocol authoring and execution remain the responsibility of the end-user’s QA department or qualified third-party service provider.