雅程 YC-03 Spray Granulation and Coating Integrated System

Overview

The YaCheng YC-03 Spray Granulation and Coating Integrated System is a laboratory-scale fluidized-bed processing unit engineered for concurrent or sequential wet granulation and film coating of particulate solids. It operates on the fundamental principles of fluidization dynamics and controlled solvent evaporation—leveraging both top-spray (for granulation) and bottom-spray (for coating) configurations within a single, reconfigurable processing chamber. In top-spray mode, a conical fluidized bed generates fountain-like particle motion; liquid binder is atomized from above, enabling rapid nucleation, growth, and densification via liquid-bridge formation followed by solid-bridge consolidation. In bottom-spray mode, particles are accelerated upward through a central draft tube by dual-channel airflow, then disperse radially into the expansion chamber before recirculating—while atomized coating solution is introduced coaxially from below, ensuring uniform droplet impingement and continuous film formation with minimal agglomeration. This dual-mode architecture supports process development aligned with ICH Q5C, Q8(R2), and FDA Guidance for Industry on Process Validation—particularly for early-phase formulation screening and scale-down studies.

Key Features

• PLC-based automation with color touchscreen HMI: real-time adjustment of inlet air temperature, product bed temperature, peristaltic pump speed, pulse-jet backflush frequency, and spray rate—without interrupting operation.
• Modular fluidized-bed geometry: interchangeable conical bowls (standard 3 L, optional 1 L / 5 L) enable scalable process mapping across batch sizes from 200 g to 3000 g.
• Triple-stage air filtration (pre-filter + medium-efficiency + HEPA) compliant with ISO 14644-1 Class 8 (equivalent to EU GMP Grade D cleanroom requirements).
• Hot-swappable nozzle assembly: standardized quick-connect interface allows full雾化头 replacement in under 60 seconds—enabling rapid transition between granulation and coating nozzles or viscosity-matched atomizers without system shutdown.
• PID-controlled thermal management: independent feedback loops for inlet air and product temperature ensure ±1.5 °C stability across the 40–150 °C operating range, critical for thermolabile APIs and sensitive excipients.
• Patented pneumatic sealing ring: eliminates manual torque calibration while maintaining leak-tight integrity (<0.5% air leakage at 2 kPa differential pressure).
• Optimized reverse-pulse backflush system: programmable timing and pressure profiles reduce filter cake accumulation, improving granule yield consistency by >12% (vs. fixed-interval systems) in high-binder formulations.

Sample Compatibility & Compliance

The YC-03 is validated for aqueous-based formulations only—including hydrophilic polymer solutions (e.g., HPMC, PVP K30), sugar syrups, starch dispersions, and colloidal suspensions. It is not rated for organic solvents, volatile carriers, or explosive dust environments. All wetted surfaces contact-grade 316L stainless steel (electropolished, Ra ≤ 0.4 µm); non-wetted structural components meet ASTM A240 Type 304. The system supports audit-ready data integrity per FDA 21 CFR Part 11 when paired with optional USB-logging firmware (timestamped, user-ID-tagged parameter logs). Documentation packages include IQ/OQ protocols aligned with ISO 9001:2015 and EU Annex 15 requirements.

Software & Data Management

The embedded control software records all critical process parameters at 1 Hz resolution—including inlet/outlet air temperatures, relative humidity, static pressure drop across filters, bed temperature, spray flow rate, and backflush event timestamps. Data export is supported via USB 2.0 (CSV format) or optional Ethernet interface (Modbus TCP). Audit trail functionality includes operator login/logout events, parameter change history with pre-/post-values, and electronic signature fields for batch release. Raw datasets comply with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) and are structured for direct import into statistical process control (SPC) platforms such as JMP or Minitab.

Applications

The YC-03 serves as a platform for formulation development and quality-by-design (QbD) studies in regulated and non-regulated sectors. Key use cases include: granulation of immediate-release tablets using microcrystalline cellulose and lactose blends; enteric coating of probiotic microcapsules (≥50 µm) with Eudragit® L30D-55; sustained-release matrix granules via ethylcellulose film deposition; functional food ingredient encapsulation (e.g., omega-3 oils in maltodextrin); ceramic precursor granule conditioning prior to sintering; and pigment agglomeration control in inkjet pigment dispersions. Its reproducibility supports DOE-driven optimization of critical process parameters (CPPs) influencing CQAs such as particle size distribution (PSD), tap density, dissolution profile, and coating uniformity (assessed via Raman chemical imaging or SEM-EDS).

FAQ

Can the YC-03 handle organic solvents like ethanol or acetone?

No. The system is designed exclusively for aqueous-based processing. Solvent compatibility requires explosion-proof modifications, inert gas purging, and additional safety interlocks—not included in the standard configuration.
What is the minimum particle size that can be reliably coated using the bottom-spray module?

The bottom-spray configuration has been verified for uniform coating of particles ≥50 µm under optimized airflow and spray rate conditions. Sub-50 µm powders require supplemental electrostatic charging or fluidization aids to prevent elutriation.
Is GMP documentation (e.g., FAT/SAT reports, material certificates) available?

Yes. Full validation support documentation—including material traceability (EN 10204 3.1), weld maps, surface finish reports, and factory acceptance test protocols—is provided upon order confirmation.
Does the system meet USP or Ph. Eur. 2.9.35 requirements for fluidized-bed processors?

While not certified to those monographs directly, the YC-03’s design basis—airflow uniformity (±5% velocity deviation across bed cross-section), temperature gradient control (<±2 °C axial variance), and residue limits (<10 ppm residual moisture)—aligns with the performance criteria outlined in both standards.
Can third-party analytical probes (e.g., FBRM, PVM, NIR) be integrated?

Yes. The expansion chamber features two standardized 25 mm optical ports (ISO-KF25) and one 1/2″ NPT threaded port for inline sensor integration. Custom mounting brackets and signal interface wiring harnesses are available as optional accessories.