BIOCOOL Pilot10-15T Silicon Oil Heated Shelf Freeze Dryer

Overview

The BIOCOOL Pilot10-15T is a silicon oil-heated shelf pilot-scale freeze dryer engineered for reproducible, scalable lyophilization of pharmaceuticals, biologics, diagnostics, and high-value research formulations. Unlike vapor-compression or electric-resistance heated systems, this unit employs a closed-loop silicon oil thermal fluid circuit—providing precise, uniform, and bidirectional temperature control across all shelves (−50 °C to +80 °C) with minimal thermal lag. The system operates on the fundamental principle of sublimation under deep vacuum: frozen product is dried by removing ice directly from the solid phase to vapor, bypassing the liquid state—thereby preserving thermolabile structures, enzymatic activity, and protein conformation. With a validated lyophilization area of 1 m² and a condenser rated for 15 kg of ice removal per 24 hours, the Pilot10-15T bridges laboratory process development and early-stage commercial manufacturing—supporting vial-based fill volumes up to 2268 × 22 mL serum vials or ≥15 kg of bulk liquid per batch.

Key Features

• Silicon oil circulation system with PID-controlled heating/cooling for ±0.5 °C shelf temperature uniformity (measured per ASTM F2673)
• Five actively heated/cooled shelves plus one passive radiation shelf—optimized for heat transfer efficiency and batch homogeneity
• Stainless steel (AISI 316L) chamber and condenser, electropolished to Ra ≤ 0.4 µm for cleanability and corrosion resistance
• High-efficiency dual-stage vacuum system with oil-lubricated rotary vane pump and optional cold trap—achieving ≤2.5 Pa ultimate pressure
• GMP-compliant construction: fully welded seams, zero dead-leg piping, slope-drainable condenser, and ISO Class 5-compatible surface finish
• Integrated PLC with HMI touchscreen interface supporting recipe storage, real-time parameter logging, and alarm history (with timestamp and operator ID)

Sample Compatibility & Compliance

The Pilot10-15T accommodates standard pharmaceutical primary packaging formats—including 10–30 mL serum vials (e.g., 22 mL Schott Type I glass), trays for bulk lyophilization, and custom aluminum pans. Its chamber geometry and shelf layout support both stoppered and open-container configurations during primary drying. All wetted materials comply with USP , ISO 10993-5, and FDA-recommended extractables/leachables screening protocols. The system is designed and documented in alignment with EU GMP Annex 1 (2022), PIC/S PI 007-6, and WHO TRS 986 Annex 2 requirements for aseptic processing equipment. Mechanical design adheres to GB/T 5226.1–1996 (equivalent to IEC 60204-1) for electrical safety, while structural integrity meets ASME BPVC Section VIII Div. 1 criteria for pressure boundary components.

Software & Data Management

The embedded control system records all critical process parameters—including shelf temperature (per shelf), condenser temperature, chamber pressure (capacitance manometer), and vacuum pump status—at user-defined intervals (minimum 1-second resolution). Data are stored locally on an encrypted industrial SSD with ≥1-year retention capacity and exportable via USB or Ethernet to CSV or PDF formats. Audit trail functionality complies with FDA 21 CFR Part 11 requirements: all operator actions, setpoint changes, and alarm acknowledgments are time-stamped, user-identified, and non-erasable. Optional IQ/OQ validation packages include protocol templates, test scripts, calibration certificates (NIST-traceable), and deviation reporting workflows aligned with ISO/IEC 17025 and ALCOA+ data integrity principles.

Applications

• Process development and scale-up studies for monoclonal antibodies, vaccines, and mRNA-LNP formulations
• Stability batch production under ICH Q5C conditions (25 °C/60% RH, 40 °C/75% RH)
• Lyophilization cycle optimization using Design of Experiments (DoE) methodology
• Pre-commercial clinical trial material (CTM) manufacturing under GLP/GMP hybrid environments
• Raw material drying for sterile APIs where residual moisture must be controlled to ≤1.0% w/w
• Academic and contract development lab use requiring full traceability, repeatability, and regulatory submission readiness

FAQ

What is the maximum allowable load per shelf during freezing?
Maximum shelf load is determined by thermal mass and heat transfer rate—not just volume. For optimal freezing kinetics, we recommend ≤12 kg of aqueous solution per shelf (total 60 kg across five shelves) when pre-freezing at −45 °C over 4–6 hours.
Does the system support automated pressure rise testing (PRT)?
Yes—the integrated vacuum control module supports programmable PRT sequences with automatic calculation of drying endpoint based on pressure rise slope (dP/dt), configurable per shelf zone.
Can the unit be integrated into a cleanroom environment with Class A airflow?
Yes—optional HEPA-filtered recirculation mode, pass-through port interfaces, and external exhaust ducting kits enable seamless integration into ISO 5 or EU GMP Grade A/B classified spaces.
Is remote monitoring supported?
Standard Ethernet TCP/IP interface enables secure remote access via OPC UA or Modbus TCP for SCADA integration; no cloud dependency or vendor-hosted platforms required.
What validation documentation is included with delivery?
Factory-issued IQ/OQ protocols, as-built drawings, material certifications (3.1), FAT report, and calibration certificates for all critical sensors are provided prior to shipment. URS review and site-specific SAT support are available upon request.