BIOCOOL Pilot5-8S Pilot-Scale Vacuum Freeze Dryer
| Brand | BIOCOOL |
|---|---|
| Origin | Beijing, China |
| Manufacturer Type | Authorized Distributor |
| Product Category | Domestic |
| Model | Pilot5-8S |
| Price Range | USD 14,000 – 70,000 |
| Instrument Type | Standard Shelf-Type Freeze Dryer |
| Application Scope | Pilot-Scale Production |
| Lyophilization Area | 1 m² |
| Ultimate Vacuum | <10 Pa |
| Condensate Capacity (24 h) | 10 L |
| Cold Trap Temperature | −55 °C |
Overview
The BIOCOOL Pilot5-8S is a pilot-scale shelf-type vacuum freeze dryer engineered for reproducible, scalable lyophilization of thermolabile biopharmaceuticals, diagnostics, and research-grade biological materials. It operates on the fundamental principle of sublimation under deep vacuum: frozen water is removed directly from the solid to vapor phase without passing through liquid, preserving structural integrity, activity, and stability of sensitive compounds. Designed for transition from lab-scale development to early-stage manufacturing, the system integrates robust refrigeration architecture, precise shelf temperature control, and real-time process monitoring—enabling GMP-aligned process definition, transfer, and documentation in compliance with ICH Q5C, Q5A(R2), and USP .
Key Features
- Aerospace-grade acrylic observation door: seamless, leak-tight construction with high impact resistance and optical clarity for continuous visual process monitoring without vacuum interruption.
- Shelf pre-freezing capability: enables in-situ freezing of bulk solutions or suspensions prior to primary drying—eliminating reliance on external ultra-low temperature freezers and minimizing thermal history variability.
- Industrial-grade hermetic compressor: high-efficiency, low-noise operation with stable condensing performance at −55 °C cold trap temperature; optimized for continuous 24-hour duty cycles.
- High-speed dual-stage rotary vane vacuum pump: 6 L/s pumping speed ensures rapid evacuation to <10 Pa base pressure and maintains dynamic vacuum stability during ice sublimation.
- Inert gas backfilling port: supports controlled nitrogen or argon purging post-drying for oxygen-sensitive formulations, enhancing long-term stability of lyophilized cakes.
- 10.4″ industrial capacitive touchscreen HMI: intuitive menu navigation, context-sensitive prompts, and full operational logic embedded—no manual required for routine start-up, cycle execution, or parameter review.
Sample Compatibility & Compliance
The Pilot5-8S accommodates aqueous solutions, colloidal suspensions, and viscous pastes with eutectic temperatures above −30 °C—covering common monoclonal antibodies, vaccines, enzyme preparations, and diagnostic reagents. Its design conforms to mechanical safety standards per ISO 12100 and electrical safety per IEC 61010-1. Data integrity features—including audit-trail-enabled event logging, user-access levels, and timestamped parameter changes—support alignment with FDA 21 CFR Part 11 and EU Annex 11 requirements when configured with optional PC database integration. All temperature and vacuum sensors are field-calibratable to NIST-traceable references, ensuring metrological continuity across equipment lifetime.
Software & Data Management
The integrated freeze-drying control system supports fully programmable multi-step cycles (freezing, annealing, primary drying, secondary drying, and purge) with up to 500 user-defined or factory-stored recipes. Real-time data acquisition occurs at 20 Hz (50 ms interval) for shelf temperature, product thermocouple readings (optional), chamber pressure, and cold trap temperature. Storage options include: internal flash memory (retains ≥90 days of compressed cycle logs), USB 2.0 external storage (FAT32 formatted), and optional Ethernet-connected PC database (SQL-based, configurable retention policy). All stored curves support export in CSV format for statistical analysis (e.g., JMP, MATLAB) and regulatory submission packages.
Applications
- Process development and scale-up studies for injectable biologics under QbD frameworks.
- Stability batch production for Phase II/III clinical trial material.
- Lyophilization of cell culture media, microbial cultures, and PCR master mixes requiring high recovery viability.
- Preservation of reference standards and calibration materials in analytical laboratories.
- Academic and contract research organizations conducting formulation optimization and excipient screening.
FAQ
What is the maximum allowable sample volume per cycle?
Up to 10 L of aqueous solution or suspension may be processed uniformly across the 1 m² shelf area—subject to cake height constraints and heat transfer limitations.
Does the system support shelf temperature ramping during primary drying?
Yes—programmable shelf heating profiles allow controlled linear or stepwise ramping, critical for optimizing mass transfer rates while avoiding collapse or melt-back.
Can the cold trap be defrosted without breaking vacuum?
No—defrosting requires venting to atmosphere; however, the non-electric, ambient-air-assisted defrost mechanism minimizes downtime and eliminates risk of thermal shock to the condenser coil.
Is remote monitoring supported?
Standard Ethernet interface enables Modbus TCP communication for integration into facility SCADA systems; optional OPC UA gateway available upon request.
What validation documentation is provided?
Factory acceptance test (FAT) report, IQ/OQ protocol templates, and as-built P&ID diagrams are included; site-specific qualification support is available under service agreement.
