Yacheng / PILOTECH YC-610 Laboratory High-Efficiency Film Coating Machine

Overview

The Yacheng / PILOTECH YC-610 Laboratory High-Efficiency Film Coating Machine is an engineered platform for precision-controlled, small-batch pharmaceutical coating development. Designed specifically for R&D and formulation optimization in academic labs, CROs, and QC/QA departments of pharmaceutical manufacturers, it operates on the principle of **perforated rotating drum fluidized-bed coating**, combining controlled tangential motion, regulated thermal airflow, and programmable atomized spray deposition. Unlike conventional pan coaters relying solely on gravitational tumbling, the YC-610 integrates Z-pattern baffle geometry and streamlined agitator dynamics to induce extended residence time and multi-directional particle trajectory—critical for achieving uniform film thickness on delicate substrates such as mini-tablets, gelatin capsules, and enteric-coated cores. Its fully enclosed, negative-pressure chamber ensures operator safety, environmental containment, and consistent drying kinetics under ISO Class 7–8 cleanroom-compatible conditions.

Key Features

• 7-inch color touchscreen HMI with integrated PLC control system enabling real-time monitoring and logging of critical process parameters: inlet air temperature, drum surface temperature, fan frequency, atomization pressure, needle purge interval, drum rotation speed, and peristaltic pump feed rate.
• Z-pattern baffle configuration inside the coating drum—engineered to elongate particle path length and enhance inter-particle mixing without excessive attrition—improving coating homogeneity by up to 35% compared to standard radial baffles (based on internal validation studies).
• Adjustable wide-angle atomization nozzle with dedicated carrier gas supply: enables dynamic modulation of spray fan width during operation to accommodate variable batch sizes (100–400 g) and drum diameters (standard φ210 mm, customizable).
• Dual-stage airflow architecture: optimized inlet and outlet air ducts (venturi-style air hoods) maximize heat transfer efficiency across the tablet bed while minimizing thermal stratification and moisture trapping.
• Integrated anti-wall adhesion agitator: specially contoured impeller design prevents tablet slippage or wall sticking during low-speed or high-viscosity coating cycles—ensuring consistent mass movement even with sub-3 mm mini-tablets.
• Self-cleaning spray gun with automated needle purge function: programmable purge frequency and dwell time prevent nozzle clogging; real-time atomization pressure feedback triggers automatic pump shutdown if pressure deviates beyond ±5% of setpoint—eliminating drips and streaking.
• PID-controlled heating system (3 kW, ±0.5°C stability) coupled with variable-frequency fan (1.5 m³/min max, 0–100% adjustable) delivers precise thermal management essential for solvent-based and aqueous polymer systems (e.g., HPMC, Eudragit® L100/FS, cellulose acetate phthalate).

Sample Compatibility & Compliance

The YC-610 supports diverse solid oral dosage forms including immediate-release tablets (2–12 mm), soft/hard gelatin capsules (size 00–5), multiparticulates, and microtablets (≥1.5 mm). It accommodates both organic solvent-based (e.g., ethanol/IPA) and aqueous polymeric dispersions. The unit complies with fundamental mechanical safety standards per IEC 61000-6-2/6-4 and meets electrical safety requirements under GB 4793.1–2019 (equivalent to IEC 61010-1). While not certified for GMP production, its data integrity architecture—including timestamped parameter logging, user-access levels, and non-editable audit trails—supports GLP-aligned documentation and facilitates FDA 21 CFR Part 11 readiness when deployed with validated third-party software extensions.

Software & Data Management

All operational data—including temperature profiles, airflow rates, rotation speeds, and spray timing—are automatically timestamped and stored locally on an industrial-grade SD card (16 GB included). Export formats include CSV and PDF reports compatible with LIMS integration. Optional Ethernet/Wi-Fi module enables remote monitoring via secure web interface (HTTPS/TLS 1.2), supporting centralized lab fleet management. Raw parameter logs are structured for direct import into statistical process control (SPC) platforms such as JMP or Minitab for DoE analysis and coating process characterization.

Applications

• Formulation screening of film-coating polymers (e.g., Opadry®, Kollicoat®, Aquacoat®) under controlled humidity and thermal gradients.
• Enteric coating development using pH-sensitive resins—validated with dissolution testing per USP and Ph. Eur. 2.9.3.
• Functional coating trials: taste masking, moisture barrier enhancement, and controlled-release layer deposition.
• Process transfer support from lab-scale (YC-610) to pilot-scale perforated drum coaters (e.g., Glatt GPCG series) via scalable geometric and aerodynamic similarity modeling.
• Stability-indicating method development for coated dosage forms exposed to accelerated aging (ICH Q1A).

FAQ

What is the minimum batch size supported for microtablet coating?
The YC-610 achieves reproducible coating down to 100 g batches; optional micro-drum configuration (φ120 mm) enables stable processing of tablets as small as 1.5 mm diameter.
Can the system be validated for GxP environments?
While the base hardware meets foundational safety and traceability requirements, full 21 CFR Part 11 compliance requires supplementary software validation packages and IQ/OQ protocols—available upon request through Yacheng’s global service team.
Is the spray nozzle compatible with highly viscous ethylcellulose suspensions?
Yes—the dual-pressure nozzle (main atomizing air + auxiliary sweep air) maintains consistent雾化 performance up to 800 cP at 35°C when paired with pre-heated feed lines and calibrated peristaltic pumping.
How is dust containment managed during loading/unloading?
The drum features a quick-clamp sealed door with silicone gasket and integrated vacuum interlock—preventing powder escape during operation and ensuring OEL-compliant handling of potent compounds.
Does the system support automated recipe recall and execution?
Yes—up to 99 user-defined protocols can be saved, each with independent setpoints for temperature ramping, airflow staging, and spray sequencing—enabling unattended overnight runs with alarm-triggered pause/resume logic.