BIOCOOL Pilot10-15T Pilot-Scale Freeze Dryer
| Brand | BIOCOOL |
|---|---|
| Origin | Beijing, China |
| Model | Pilot10-15T |
| Type | Shelf-Type Freeze Dryer |
| Application | Pilot-Scale Processing |
| Freeze-Drying Area | 1 m² |
| Ultimate Vacuum | ≤ 2.5 Pa |
| Condensate Capacity (24 h) | 15 L/24 h |
| Cold Trap Temperature (No Load) | ≤ −80 °C |
| Shelf Temperature Range (No Load) | ≤ −50 °C |
| Shelf Dimensions | 350 mm × 600 mm |
| Number of Shelves | 5 + 1 Radiant Shelf |
| Shelf Spacing | 70 mm |
| Installed Power | 8 kW (3-Phase) |
| Unit Dimensions (W×D×H) | ≈ 880 × 2200 × 1900 mm |
| Unit Weight | ≈ 1200 kg |
| Noise Level | ≤ 70 dB(A) |
| Compliance | GMP, GB/T 5226.1–1996 |
Overview
The BIOCOOL Pilot10-15T is a pilot-scale shelf-type freeze dryer engineered for reproducible, scalable lyophilization under controlled thermal and vacuum conditions. It operates on the fundamental principles of sublimation—removing water from frozen product via direct phase transition from solid to vapor under low-pressure environments—enabling preservation of thermolabile biologics, pharmaceuticals, diagnostics, and high-value research materials. Designed specifically for process development, formulation optimization, and small-batch GMP-compliant manufacturing, the system bridges laboratory feasibility studies and commercial production. Its 1 m² shelf area supports representative batch sizes—including up to 2,268 × 22 mL vials or ≥15 kg of bulk liquid—while maintaining uniform heat transfer across five primary shelves plus one radiant shelf for enhanced drying homogeneity.
Key Features
- Robust stainless-steel chamber and condenser housing compliant with ISO 14644-1 Class 8 cleanroom-compatible construction.
- Five temperature-controlled shelves plus an additional radiant shelf, each independently monitored and capable of achieving ≤ −50 °C (no load), enabling precise control over primary and secondary drying stages.
- Cryogenic cold trap with ≤ −80 °C capability (no load) and 15 L/24 h condensate capacity, optimized for high-moisture-load formulations including aqueous buffers, protein solutions, and cell culture media.
- Ultimate vacuum performance ≤ 2.5 Pa, sustained via dual-stage oil-lubricated rotary vane pump with integrated vacuum regulation and real-time pressure feedback.
- Integrated PLC-based control system with Ethernet connectivity, supporting programmable multi-step drying cycles, ramp/soak profiles, and alarm-triggered safety interlocks (e.g., overtemperature, vacuum loss, power failure).
- Full GMP design alignment: smooth-welded internal surfaces, sloped drain paths, validated SIP/CIP compatibility, and documentation-ready architecture for IQ/OQ/PQ execution.
Sample Compatibility & Compliance
The Pilot10-15T accommodates diverse sample formats including glass vials (e.g., 22 mm diameter), serum bottles, trays, and custom containers—ideal for lyophilizing monoclonal antibodies, vaccines, enzyme preparations, probiotics, and sterile APIs. All wetted parts are electropolished AISI 316L stainless steel; non-wetted components meet USP Class VI biocompatibility requirements. The system is designed and manufactured in accordance with GB/T 5226.1–1996 (equivalent to IEC 60204-1), and its mechanical, electrical, and control architecture supports compliance with Annex 1 of EU GMP, FDA 21 CFR Part 11 (when paired with validated software), and WHO TRS 986 Annex 6. Full validation documentation—including FAT/SAT protocols, traceable calibration records, and URS-mapped test reports—is provided upon delivery.
Software & Data Management
The embedded HMI interface provides intuitive cycle setup, real-time graphical monitoring of shelf temperature, chamber pressure, condenser temperature, and product thermocouple readings. Optional data logging software enables export of time-stamped CSV files with audit trail functionality meeting ALCOA+ principles. When configured with BIOCOOL’s optional GMP-compliant software package, the system supports electronic signatures, user access levels (admin/operator/auditor), and 21 CFR Part 11–compliant electronic records—including immutable cycle logs, parameter change history, and deviation annotations. All data is stored locally on industrial-grade SSD with redundant backup options.
Applications
- Pharmaceutical process development: lyophilization cycle design, critical quality attribute (CQA) mapping, and shelf-life prediction studies.
- Biotechnology: stabilization of recombinant proteins, viral vectors, and mRNA-LNP formulations prior to clinical supply.
- Academic & contract research: reproducible scale-up modeling between lab-scale (e.g., Labconco FreeZone) and production-scale systems.
- Diagnostic reagent manufacturing: dehydration of enzyme conjugates, immunoassay standards, and PCR master mixes without activity loss.
- Food & nutraceutical R&D: gentle removal of moisture from probiotics, botanical extracts, and functional peptides while retaining bioactivity.
FAQ
What is the maximum batch size supported by the Pilot10-15T?
The system supports up to 2,268 × 22 mm vials or ≥15 kg of bulk liquid per cycle, based on standard loading density and formulation-specific drying kinetics.
Does the unit support steam-in-place (SIP) or clean-in-place (CIP)?
Yes—the chamber and condenser are SIP-capable up to 121 °C for 30 minutes; CIP integration is available via external skid-mounted system with validated spray ball coverage.
Is remote monitoring possible?
Standard Ethernet port enables Modbus TCP communication; optional OPC UA server allows integration into MES/SCADA platforms for centralized supervision.
What validation support is included?
BIOCOOL delivers full IQ/OQ documentation packages, including URS, FDS, SAT reports, calibration certificates for all sensors, and PQ protocol templates aligned with ISO 13485 and ICH Q5C guidelines.
Can shelf temperature be controlled independently during primary drying?
Yes—each shelf is equipped with individual Pt100 sensors and PID-controlled heating/cooling circuits, enabling gradient-freeze or differential shelf profiling as required for complex formulations.
