BIOCOOL Pilot10-15M Pilot-Scale Freeze Dryer
| Brand | BIOCOOL |
|---|---|
| Origin | Beijing, China |
| Model | Pilot10-15M |
| Type | Standard Shelf-Type Freeze Dryer |
| Application | Pilot-Scale Processing |
| Lyophilization Area | 1.0 m² |
| Ultimate Vacuum | ≤3 Pa |
| Condensate Capacity (24 h) | 15 L/24 h |
| Cold Trap Temperature | <−85 °C |
| Shelf Temperature Range (Empty) | −40 to +60 °C |
| Shelf Cooling Method | Silicone Oil Circulation |
| Shelf Spacing | 85 mm |
| Compressor Power | 3 HP (Dual) |
| Vacuum Pump Speed | 4 L/s |
| Safety Features | Overcurrent Protection, Overload Protection, Shelf Overtemperature Protection, Vacuum Process Interlock, Vacuum Pump Backflow Prevention |
Overview
The BIOCOOL Pilot10-15M is a robust, industrial-grade pilot-scale freeze dryer engineered for reproducible lyophilization process development, scale-up validation, and small-batch GMP-compliant manufacturing. Based on the principle of sublimation under deep vacuum and controlled thermal input, it removes water from thermolabile materials—including biologics, pharmaceuticals, diagnostics, and functional foods—while preserving structural integrity, biological activity, and chemical stability. Designed for seamless transition from lab-scale R&D to clinical or commercial production, the Pilot10-15M features a 1.0 m² shelf area, dual high-efficiency compressors, and a <−85 °C cold trap capable of condensing up to 15 L of ice per 24 hours. Its silicone oil–circulated shelves ensure uniform temperature distribution (±0.5 °C across shelf surface), critical for consistent drying kinetics and batch homogeneity.
Key Features
- Aerospace-grade acrylic observation door: Seamless, leak-tight construction with zero adhesive bonding; enables real-time visual monitoring without compromising vacuum integrity.
- Shelf pre-freezing capability: Allows complete sample freezing directly on shelves prior to primary drying—eliminating reliance on external ultra-low freezers and reducing process variability.
- Dual-stage refrigeration system: Equipped with internationally certified compressors delivering stable cooling performance, low acoustic noise (<62 dB(A)), and extended service life under continuous operation.
- High-speed vacuum system: Integrated 4 L/s oil-sealed rotary vane pump with anti-backstreaming valve and optional oil mist filter ensures rapid evacuation and long-term vacuum stability.
- Programmable freeze-drying control: Full-cycle automation—from freezing and primary/secondary drying to defrosting—with up to 500 user-defined or factory-stored protocols.
- Intelligent shelf heating: Fuzzy PID algorithm with real-time thermal loop monitoring; uses proprietary heating elements warrantied for 3 years; supports ramp/hold profiles with ±0.3 °C setpoint accuracy.
- Non-electric cold trap defrost: Mechanical defrost mechanism eliminates electrical hazards in cold trap chambers and reduces downtime compared to immersion-based methods.
- Motorized stoppering system: Programmable vertical actuation for precise, repeatable rubber stopper compression in vials—critical for aseptic fill-finish simulation and container closure integrity testing.
- Real-time data acquisition: 50 ms sampling interval for shelf temperature, product temperature (via optional Pt100 probes), and chamber pressure; compliant with ALCOA+ data integrity principles.
Sample Compatibility & Compliance
The Pilot10-15M accommodates aqueous solutions, suspensions, emulsions, and viscous pastes with eutectic points above −40 °C (when configured with −85 °C cold trap). It supports standard 2R–50R serum vials, trays, and custom containers up to 85 mm shelf spacing. The system meets core requirements for GLP and early-phase GMP environments: full audit trail capability (with optional PC database logging), electronic signature support (21 CFR Part 11-ready when paired with validated software), and traceable calibration of temperature (±0.2 °C) and vacuum (±0.1 Pa) sensors. Optional accessories—including organic solvent traps, nitrogen/purge gas manifolds, and co-lyophilization multi-port adapters—extend compatibility to formulations containing ethanol, acetone, or tert-butanol.
Software & Data Management
Operation is managed via an industrial-grade 10.1″ capacitive touchscreen HMI with intuitive icon-driven navigation—requiring no formal training for basic cycle execution. The embedded control firmware supports three data storage modalities: internal flash memory (retains ≥90 days of compressed cycle logs), USB export (FAT32 formatted drives), and optional TCP/IP-connected PC database (SQL-based, with role-based access control and automated backup scheduling). All logged parameters—including shelf temp, chamber pressure, condenser temp, and elapsed time—are timestamped and exportable as CSV or PDF reports. Optional remote monitoring enables secure web-based supervision within a 1.5 km radius via Ethernet or 4G LTE gateway, with configurable email/SMS alerts for alarm conditions.
Applications
This system is routinely deployed in: (1) Biopharmaceutical process development—optimizing lyo cycles for monoclonal antibodies, vaccines, and viral vectors; (2) Analytical reference standard preparation—ensuring long-term stability of CRM materials; (3) Nutraceutical R&D—preserving enzymatic activity in probiotics and botanical extracts; (4) Diagnostic reagent stabilization—maintaining antigen-antibody binding affinity in lateral flow assays; (5) Academic and contract research—supporting DOE-based studies on annealing, collapse temperature, and mass transfer resistance. Its scalability allows direct correlation with production-scale freeze dryers using the same shelf heat transfer coefficients and vacuum dynamics.
FAQ
What is the maximum batch size supported by the Pilot10-15M?
With 1.0 m² of shelf area and typical loading density of 10–15 mL per 100 cm², the unit accommodates ~10–15 L of frozen solution per batch—ideal for producing 5,000–10,000 vials (10 mL fill volume) per cycle.
Is the system compatible with organic solvent removal?
Yes—when equipped with the optional organic solvent condenser (stainless steel, cryogenically cooled), it safely captures methanol, acetonitrile, and other low-boiling solvents during primary drying.
Can I validate the system per GMP requirements?
The platform supports IQ/OQ documentation packages; optional qualification services include DQ review, sensor calibration certificates (NIST-traceable), and protocol generation for thermal mapping and vacuum leak testing.
Does the system support PAT integration?
It provides Modbus TCP and RS485 interfaces for connection to third-party PAT tools (e.g., NIR, tunable diode laser spectroscopy) and MES/SCADA systems.
What maintenance intervals are recommended?
Vacuum pump oil change every 500 operating hours; cold trap cleaning every 20 cycles; annual compressor performance verification and shelf temperature uniformity mapping.
