雅程YC-1000实验室喷雾造粒包衣机

Overview

The Yacheng YC-1000 Integrated Laboratory Spray Dryer, Fluidized Bed Granulator & Coater is an engineered platform for multi-step particulate process development in pharmaceutical, food, and advanced material research laboratories. It combines four core unit operations—spray drying, fluidized bed granulation, fluidized bed drying, and film coating—within a single, compact stainless-steel architecture. Unlike conventional sequential benchtop systems, the YC-1000 enables seamless transition between modes without sample transfer, minimizing cross-contamination risk, material loss, and operator variability. Its design adheres to fundamental principles of droplet atomization (two-fluid nozzle), convective heat/mass transfer in co-current spray chambers, and controlled fluidization dynamics governed by adjustable air velocity, temperature, and pulsation frequency. The system is explicitly optimized for thermolabile compounds—including peptides, probiotics, botanical extracts, and amorphous solid dispersions—where precise thermal history control (<1% residual moisture post-spray drying at 105°C inlet) and gentle particle handling are critical to preserving structural integrity and bioactivity.

Key Features

• Integrated quad-function operation: spray drying, fluidized bed granulation, fluidized bed drying, and aqueous/organic solvent-based film coating—all programmable via a unified PLC interface
• Ultra-low sample requirement: validated performance with as little as 50 g of feed material per batch, reducing raw material consumption and cost per experiment
• Space-efficient footprint: 0.5 m² floor area; fully mobile on industrial-grade casters with integrated leveling feet for stable operation on standard lab benches
• Thermal management system: PID-controlled, real-time regulation of inlet air temperature (spray drying: 105–200°C; fluidized bed: 40–150°C) with independent heating zones and redundant overtemperature cutoff
• Two-fluid pneumatic atomization: stainless-steel nozzle assembly with adjustable air pressure (1–3 bar) and programmable peristaltic pump flow (0–1500 mL/h)
• Robust construction: 316L stainless steel contact surfaces; borosilicate glass expansion chamber (10 L volume) for visual process monitoring and rapid cleaning validation
• Safety-critical shutdown logic: automatic isolation of heater and atomizer upon “Stop” command while maintaining fan operation to prevent thermal soak-back damage
• Full digital HMI: 7-inch color LCD touchscreen displaying real-time parameters including inlet/outlet temperatures, blower frequency, granulation pan temperature, pump speed, and pulse-jet backflush interval

Sample Compatibility & Compliance

The YC-1000 accommodates a broad spectrum of feedstocks: aqueous and organic solutions, suspensions, emulsions, and viscous slurries (up to 500 cP). It supports excipient-compatible formulations for immediate-release, sustained-release, and enteric-coated dosage forms. The system’s materials of construction comply with USP <381> and ISO 14644-1 Class 8 cleanroom compatibility requirements for non-sterile R&D environments. While not certified for GMP manufacturing, its architecture supports ALCOA+ data integrity principles: all critical process parameters (CPPs) are logged with timestamps, user IDs, and audit trail capability (via optional USB export or RS485 integration with LIMS). It meets CE electromagnetic compatibility (EMC) Directive 2014/30/EU and Low Voltage Directive 2014/35/EU. For regulatory submissions, process data generated on the YC-1000 may serve as foundational evidence in Q5A(R2) comparability studies and ICH Q1–Q3 stability protocols.

Software & Data Management

The embedded PLC firmware provides deterministic real-time control with cycle repeatability ≤±1.5% CV across key outputs (particle size distribution, moisture content, coating uniformity). Process recipes are stored with version control and password-protected access levels (Operator, Technician, Administrator). All operational data—including temperature ramps, airflow profiles, and pump duty cycles—are timestamped and exportable in CSV format for statistical analysis (e.g., JMP, Minitab) or integration into electronic lab notebooks (ELN). Optional firmware upgrade enables 21 CFR Part 11-compliant electronic signatures, audit trail encryption, and role-based data export restrictions—supporting GLP-aligned documentation workflows in contract research organizations (CROs) and academic core facilities.

Applications

The YC-1000 is deployed globally in formulation development labs for:

• Pharmaceutical solid dosage forms: microencapsulation of APIs, hot-melt extrusion alternatives, taste-masking of bitter drugs, and preparation of spherical crystalline agglomerates for direct compression
• Nutraceutical and functional food powders: encapsulation of omega-3 oils, probiotics, and polyphenols to enhance oxidative stability and gastric survivability
• Ceramic and battery precursor synthesis: production of spherical, dense, and phase-pure metal oxide particles (e.g., LiCoO₂, YSZ) with narrow PSD for sintering optimization
• Polymer particle engineering: stimuli-responsive hydrogel microparticles, PCL/PLGA microspheres for controlled release, and conductive polymer composites
• Agrochemical delivery systems: water-dispersible granules (WDGs) and controlled-release fertilizers with reduced environmental leaching

FAQ

Can the YC-1000 be used for sterile process development?

No—it is designed for non-sterile R&D use only. Sterile applications require ISO 5 (Class 100) isolator integration, which is outside the system’s scope.

What is the minimum batch size for fluidized bed granulation?

The validated lower limit is 100 g of powder bed mass; however, consistent nucleation and growth have been demonstrated down to 50 g with optimized binder addition rate and air velocity profiling.

Is remote monitoring supported?

Standard configuration includes RS485 Modbus RTU for integration with SCADA or building management systems; Ethernet/IP and OPC UA are available as factory-installed options.

Does the system support organic solvent processing?

Yes—with appropriate explosion-proof upgrades (ATEX Zone 2 certification kit), inert gas purging (N₂ or Ar), and solvent recovery condenser add-on modules.

How is cleaning validation performed?

The fully drainable fluidized bed pan, quick-release spray nozzle, and smooth-welded stainless-steel ducting enable visual inspection, swab sampling, and rinse recovery testing per ASTM E3039-16 guidelines.