Yacheng / PILOTECH YC-03 Fluid Bed Granulator and Coater
| Brand | Yacheng / PILOTECH |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | Direct Manufacturer |
| Country of Origin | China |
| Model | YC-03 |
| Pricing | Upon Request |
Overview
The Yacheng / PILOTECH YC-03 Fluid Bed Granulator and Coater is an integrated laboratory-scale fluidized bed processor engineered for precision wet granulation, top-spray agglomeration, and bottom-spray film coating in a single platform. It operates on two distinct fluidization modes: top-spray for granule formation via liquid bridge–solid bridge transition, and bottom-spray for uniform thin-film coating of fine particulates. In top-spray mode, material undergoes controlled upward–downward circulation within a conical bowl and expansion chamber, generating fountain-like fluidization that ensures homogeneous exposure to atomized binder solution. In bottom-spray mode, a central nozzle mounted beneath a draft tube delivers upward-directed雾化 droplets into a high-velocity particle stream; particles circulate radially outward upon exiting the draft tube, enabling consistent droplet impact, surface spreading, and rapid solvent evaporation—critical for achieving reproducible coating thickness and integrity. The system is designed for R&D scale-up studies aligned with ICH Q5A and Q5C guidelines, supporting early-phase formulation development under GLP-compliant workflows.
Key Features
- PLC-based automation with color touchscreen HMI (optional USB data export and real-time thermal printing support)
- Dual-mode operation: top-spray granulation and bottom-spray coating in one unit, configurable without hardware reconfiguration
- Modular conical processing bowl with interchangeable volumes to accommodate 100 g–3 kg batch sizes
- Triple-stage inlet air filtration (pre-filter + medium-efficiency + HEPA) compliant with ISO 14644-1 Class 8 (equivalent to EU GMP Grade D)
- Quick-change atomizing nozzles — full replacement completed in <60 seconds without process interruption or system depressurization
- Intelligent temperature coupling: real-time feedback between product temperature and inlet air temperature, governed by adaptive PID algorithms across 25–120 °C range
- Patented pneumatic sealing gasket system ensuring leak-tight operation at ±5 mbar differential pressure
- Optimized reverse-pulse air cleaning system (anti-caking pulse frequency adjustable from 1–30 min intervals) to maintain consistent fluidization and maximize granule yield
- Critical components—including centrifugal blower, tubular heating elements, and control cabinet electronics—sourced from Tier-1 European and Japanese suppliers
Sample Compatibility & Compliance
The YC-03 accommodates free-flowing powders, microcrystalline cellulose blends, API-excipient mixtures, ceramic precursors, polymer dispersions, and heat-sensitive botanical extracts. It supports particle size ranges from 50 µm (coating) to 2 mm (granulation), with minimum coating substrate diameter of 50 µm validated per USP and ASTM E2904-22. The system meets mechanical safety requirements per EN 61000-6-2/6-4 and carries CE marking. All software functions—including parameter logging, alarm history, and user access levels—support audit trails compatible with FDA 21 CFR Part 11 Annex 11 expectations when deployed with optional electronic signature modules.
Software & Data Management
The embedded control system records all critical process parameters—including inlet/outlet air temperature, product temperature, airflow rate, spray rate, nozzle pressure, and pulse cleaning timing—at 1 Hz resolution. Data is timestamped, stored locally on industrial-grade SD card (2 GB minimum), and exportable in CSV format via USB port. Optional Ethernet connectivity enables integration with LIMS or MES platforms using Modbus TCP protocol. Batch reports include metadata (operator ID, batch ID, start/end time, deviation flags), ensuring traceability for regulatory submissions under ICH M4 and WHO TRS 986 Annex 3.
Applications
- Pharmaceutical: Immediate-release granules, sustained-release coated pellets (e.g., ethylcellulose, Eudragit®), taste-masked mini-tablets, and inhalable dry powder formulations
- Nutrition & Food: Encapsulated probiotics, vitamin-enriched starch granules, flavor-loaded sugar spheres, and functional food ingredient agglomerates
- Agrochemicals: Controlled-release pesticide granules, water-dispersible granules (WDG), and micronutrient-coated seeds
- Materials Science: Ceramic green bodies, metal-organic framework (MOF) composites, conductive polymer granules, and catalyst supports
- Natural Products: Stabilized plant extract powders, essential oil microcapsules, and enzyme-protected phytochemicals
FAQ
What is the smallest particle size that can be reliably coated using the bottom-spray configuration?
Particles as small as 50 µm have been successfully coated with sub-5 µm polymer films under optimized airflow and spray rate conditions.
Does the system comply with GMP requirements for lab-scale development?
Yes—the triple-stage filtration, HEPA-grade exhaust, stainless-steel contact surfaces (316L), and electronic record retention meet EU GMP Annex 15 and USP analytical instrument qualification criteria.
Can the same bowl be used interchangeably for both top-spray and bottom-spray operations?
Yes—no hardware modification is required; only nozzle orientation and airflow profile are reconfigured via HMI menu selection.
Is remote monitoring supported out of the box?
Standard configuration includes local HMI only; remote viewing and control require optional Ethernet gateway module and secure VPN setup.
What validation documentation is provided with the system?
Factory acceptance test (FAT) report, IQ/OQ protocols (user-executable), calibration certificates for temperature and airflow sensors, and material compatibility statement are included.
