雅程 YC-03 Spray Granulation and Coating Integrated System
| Brand | YaCheng / PILOTECH |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | Direct Manufacturer |
| Origin Category | Domestic (China) |
| Model | YC-03 |
| Quotation | Upon Request |
| Sample Type Compatibility | Aqueous Solutions Only |
| Maximum Batch Capacity | 3000 g |
| Temperature Range | 40–150 °C |
| Granule Size Range | Up to 5 mm |
Overview
The YaCheng YC-03 Spray Granulation and Coating Integrated System is a bench-scale fluidized-bed processing platform engineered for concurrent or sequential wet granulation and film coating of particulate solids under controlled thermal and aerodynamic conditions. It operates on two distinct fluidization modes—top-spray for granulation and bottom-spray for coating—each optimized for specific particle dynamics and mass transfer requirements. In top-spray mode, a conical processing bowl and expansion chamber generate fountain-like fluidization, enabling uniform droplet–particle contact and progressive agglomeration via liquid bridge formation followed by solid bridge consolidation. In bottom-spray mode, a central riser tube with dual-inlet airflow establishes a well-defined core–annulus flow pattern: particles accelerate upward through the riser, disperse radially in the expansion chamber, and descend externally before re-entering the cycle. Simultaneously, atomized coating solution is introduced coaxially from below, ensuring consistent surface coverage and incremental film build-up under concurrent convective drying. This dual-mode architecture supports process development aligned with ICH Q5C, Q8(R2), and Q9 principles, particularly for formulation screening and scale-down studies prior to pilot or commercial manufacturing.
Key Features
- PLC-based automation with color touchscreen HMI, supporting real-time parameter adjustment—including inlet air temperature, bowl temperature, pulse-jet backflush frequency, and peristaltic pump speed—without interrupting operation.
- Modular bowl design enables rapid interchange of processing vessels (standard and optional volumes), facilitating scalability studies across batch sizes from grams to 3 kg.
- Triple-stage air filtration system (pre-filter + medium-efficiency + HEPA) ensures inlet air meets ISO 14644-1 Class 8 (equivalent to EU GMP Grade D) cleanliness requirements for non-sterile pharmaceutical development.
- Hot-swappable atomizer assembly: nozzle modules can be exchanged in ≤60 seconds without halting airflow or heating, minimizing downtime during process optimization or multi-formulation runs.
- Integrated PID-controlled temperature regulation with feed-forward compensation between inlet air and bed temperature feedback loops, maintaining thermal stability within ±1.5 °C across the full 40–150 °C operating range.
- Pneumatic sealing system utilizing inflatable elastomeric gaskets ensures leak-tight containment during fluidized-bed operation and simplifies maintenance access.
- Dedicated backflush pulse-jet system mitigates filter cake buildup on the cyclone and bag filter, improving granule yield consistency and extending filter service life.
Sample Compatibility & Compliance
The YC-03 is validated for aqueous-based formulations only; organic solvents are not supported due to safety and regulatory constraints inherent in open-loop drying configurations. It accommodates free-flowing powders, microcrystalline cellulose, lactose monohydrate, starch derivatives, and other excipients commonly used in oral solid dosage form development. The system complies with CE machinery directive 2006/42/EC and conforms to electrical safety standards IEC 61000-6-2 (immunity) and IEC 61000-6-4 (emissions). While not certified for GMP production, its design supports GLP-compliant documentation practices—including audit-trail-capable data logging (via optional USB export)—and aligns with FDA 21 CFR Part 11 readiness when paired with validated software extensions.
Software & Data Management
The embedded control interface records all critical process variables—including inlet/outlet temperatures, airflow rate, spray rate, and pressure differentials—at user-defined intervals (1–60 s). Data export is supported via USB flash drive in CSV format for offline analysis in MATLAB, JMP, or Python-based modeling environments. Optional Ethernet connectivity enables integration into laboratory-wide SCADA systems or centralized LIMS platforms. All logged parameters include timestamps with millisecond resolution and are stored with immutable metadata (operator ID, batch ID, version-stamped firmware ID), satisfying traceability requirements under ISO/IEC 17025 and USP .
Applications
This system serves as a primary tool in preformulation and formulation development laboratories across regulated and non-regulated sectors. Key use cases include: development of immediate- and modified-release tablet granules; enteric or sustained-release polymer film coatings (e.g., Eudragit® L100, HPMC AS); taste-masking of pediatric APIs; stabilization of heat-sensitive botanical extracts via matrix granulation; microencapsulation of probiotics or enzymes; granulation of ceramic precursors for sintering studies; and functional coating of food-grade carriers (e.g., maltodextrin, gum arabic) for flavor or nutrient delivery. Its operational flexibility supports DOE-driven experimentation for QbD implementation and supports regulatory filing documentation per ICH M4Q(R2).
FAQ
Can the YC-03 handle organic solvent-based coatings?
No. The system is designed exclusively for aqueous solutions to comply with explosion-proof and ventilation safety standards applicable to unclassified laboratory environments.
What is the minimum particle size suitable for bottom-spray coating?
The bottom-spray configuration supports coating of particles down to 50 µm, provided they exhibit sufficient fluidization characteristics and density contrast relative to air.
Is the temperature control system validated for IQ/OQ protocols?
Yes—temperature sensors are calibrated traceable to NIST standards, and the PID controller’s setpoint accuracy and ramp/soak performance can be verified using external thermocouple probes per ASTM E2251.
Does the system support continuous operation across multiple batches?
While designed for batch processing, automated cleaning-in-place (CIP) routines and hot-swappable components enable rapid turnover between consecutive batches with minimal cross-contamination risk.
Are spare parts and technical documentation available in English?
Yes—full English-language operation manuals, electrical schematics, and exploded-view parts diagrams are supplied with each unit, along with a 24-month warranty on core components.
