BIOCOOL Pilot10-15T Wall-Mounted Pilot-Scale Freeze Dryer
| Brand | BIOCOOL |
|---|---|
| Origin | Beijing, China |
| Model | Pilot10-15T (Wall-Mounted Pilot-Scale Freeze Dryer) |
| Type | Shelf-Type Freeze Dryer |
| Application Scale | Pilot-Scale |
| Shelf Area | 1 m² |
| Ultimate Vacuum | ≤ 2.5 Pa |
| Condensate Capacity (24 h) | 15 kg/24 h |
| Cold Trap Temperature | ≤ −80 °C |
| Shelf Minimum Temperature (Empty) | ≤ −50 °C |
| Installed Power | 8 kW (3-Phase) |
| Dimensions (W×D×H) | 880 × 2200 × 1900 mm |
| Weight | ~1200 kg |
| Noise Level | ≤ 70 dB(A) |
| Compliance | GMP, GB/T 5226.1–1996 |
Overview
The BIOCOOL Pilot10-15T is a wall-mounted, pilot-scale freeze dryer engineered for reproducible lyophilization process development and scale-up validation under regulated pharmaceutical and biotechnology environments. It operates on the fundamental principles of sublimation-based primary drying and desorption-based secondary drying, utilizing a dual-stage refrigeration system to maintain condenser temperatures at or below −80 °C—enabling efficient capture of water vapor from thermolabile biologicals, vaccines, monoclonal antibodies, and sterile APIs. With a total shelf area of 1 m² distributed across five active temperature-controlled shelves plus one radiative shelf, the unit supports representative batch sizes suitable for Phase II/III clinical trial material production and formulation optimization. Its wall-mounted configuration facilitates cleanroom integration via pass-through design, minimizing cross-contamination risk and supporting ISO Class 5–7 facility layouts.
Key Features
- Five independently controlled stainless-steel shelves (350 mm × 600 mm each) with 70 mm spacing—optimized for uniform heat transfer and consistent cake morphology across vials, trays, and serum bottles.
- Radiative shelf (6th shelf) enhances thermal uniformity during secondary drying without direct contact, improving moisture removal efficiency in low-residual-moisture applications.
- Cryogenic cold trap rated to ≤ −80 °C (empty load), equipped with dual-stage cascade refrigeration and high-efficiency defrost cycle management.
- Ultimate vacuum capability of ≤ 2.5 Pa achieved via oil-lubricated dual-stage rotary vane pump (pump not included), compatible with optional dry vacuum pump upgrades for solvent compatibility and reduced maintenance.
- GMP-compliant construction: AISI 316L stainless steel chamber and shelves; electropolished surfaces; fully drainable condenser; integrated SIP-compatible steam inlet ports (optional).
- Robust electrical architecture with 8 kW installed capacity (3-phase, 380 V), designed for stable operation under variable grid conditions; actual energy consumption typically remains below 8 kWh per drying cycle depending on load and cycle profile.
Sample Compatibility & Compliance
The Pilot10-15T accommodates standard pharmaceutical primary packaging formats including 22 mm serum vials (up to 2268 units per batch), aluminum trays (≥15 kg liquid equivalent), and custom molds for solid dosage forms. All wetted parts comply with USP Class VI and ISO 10993 biocompatibility standards. The system is engineered and documented in accordance with Good Manufacturing Practice (GMP) requirements as outlined in Annex 1 of EU GMP Guidelines, FDA Guidance for Industry: Lyophilization Process Validation, and Chinese GMP 2010. Full factory acceptance testing (FAT) and site acceptance testing (SAT) protocols—including IQ/OQ documentation templates—are provided. Design qualification (DQ) supports alignment with ICH Q5C stability guidelines and USP Sterility Assurance requirements.
Software & Data Management
Equipped with BIOCOOL’s proprietary LyoControl™ v4.2 SCADA-based control system, the Pilot10-15T delivers real-time monitoring of shelf temperature (±0.3 °C accuracy), chamber pressure (capacitance manometer, ±0.1 Pa resolution), condenser temperature, and vacuum pump status. All operational parameters are time-stamped and stored locally with ≥12-month retention. Audit trail functionality complies with FDA 21 CFR Part 11 requirements, including electronic signatures, role-based access control, and immutable data export (CSV, PDF). Optional integration with LIMS or MES platforms is supported via OPC UA and Modbus TCP protocols. Cycle development tools include pre-programmed recipes, ramp/soak logic, and pressure rise test (PRT) automation for endpoint determination.
Applications
- Process characterization and scale-down modeling for commercial freeze dryers (e.g., comparison against 10–20 m² production units).
- Formulation screening of cryoprotectants, bulking agents, and surfactants under controlled nucleation and annealing conditions.
- Stability studies per ICH Q1A(R2) requiring long-term storage assessment of lyophilized intermediates.
- Regulatory filing support: generation of process validation reports (PVR), batch records, and critical process parameter (CPP) sensitivity analyses.
- Vaccine and cell/gene therapy product development where residual moisture content (<1.0 wt%) and reconstitution time must be tightly controlled.
FAQ
What is the maximum vial loading capacity for 22 mm serum vials?
Up to 2268 units per full-shelf batch, assuming standard 2 mL fill volume and 10 mm headspace.
Does the system include a vacuum pump?
No—the Pilot10-15T requires an external vacuum pump; recommended configurations include oil-sealed rotary vane pumps or dry scroll pumps for solvent-laden processes.
Can this unit be validated for GMP manufacturing use?
Yes—full IQ/OQ documentation packages, FAT/SAT protocols, and traceable calibration certificates for all critical sensors are supplied as standard.
Is remote monitoring supported?
Yes—via secure Ethernet connection using built-in web server interface; remote desktop access is available under controlled IT governance policies.
What is the minimum shelf temperature under no-load conditions?
≤ −50 °C, verified per ASTM E2212-21 thermal mapping procedure using calibrated PT100 sensors.
