雅程实验室肠溶衣高效包衣机YC-610

Overview

The Yacheng YC-610 Laboratory-Scale High-Efficiency Enteric Coating Machine is an engineered solution for precision film coating development in pharmaceutical R&D and formulation laboratories. Designed around the core principle of **perforated pan coating with controlled fluidized airflow and programmable spray dynamics**, the system enables reproducible application of enteric, sustained-release, and functional polymeric coatings onto tablets, capsules, and mini-tablets. Its operation relies on a rotating perforated drum (coating pan) driven by a variable-frequency motor, combined with precisely regulated hot-air flow under negative pressure, synchronized nozzle-based atomization, and real-time thermal and pneumatic feedback control. This architecture ensures uniform droplet deposition, rapid solvent evaporation, and minimal thermal stress—critical parameters for maintaining API stability and achieving target dissolution profiles per USP and Ph. Eur. 2.9.40.

Key Features

• 7-inch color touchscreen HMI with integrated PLC control system, displaying and logging real-time process variables: inlet air temperature, pan surface temperature, fan frequency, atomization pressure, needle purge interval, pan rotation speed, and peristaltic pump feed rate
• Z-pattern baffle design inside the coating pan to induce extended, multi-directional tumbling trajectories—enhancing coating homogeneity and reducing edge accumulation
• Adjustable spray nozzle with dual-pneumatic actuation: independent control of fan angle width and atomization pressure (displayed and limit-settable on screen) to accommodate varying batch sizes and pan geometries
• Optimized airflow architecture featuring conical inlet and outlet ducts (wind hoods), improving heat transfer efficiency across the tablet bed and minimizing dead zones
• Dual-mode pan configuration support: standard φ210 mm pan (100–400 g/batch) plus optional micro-tablet pan kit for sub-3 mm dosage forms, addressing challenges in pediatric and high-potency formulation development
• Self-cleaning spray gun with integrated needle purge function; purge frequency and duration fully programmable via touchscreen interface
• Safety-integrated atomization control: automatic peristaltic pump shutdown if atomization pressure falls outside user-defined thresholds—preventing drips, pooling, or non-uniform film formation
• 370 W brushless motor with infinitely variable speed control (0–25 rpm typical range), enabling precise optimization of tablet motion dynamics for fragile or irregularly shaped cores

Sample Compatibility & Compliance

The YC-610 accommodates conventional immediate-release tablets (5–12 mm), gelatin and HPMC capsules, film-coated placebo cores, and micro-tablets down to 1.5 mm diameter when equipped with the optional micro-pan assembly. All wetted parts contact surfaces are constructed from electropolished 316L stainless steel, compliant with ASME BPE surface finish standards (Ra ≤ 0.4 µm). The system supports full traceability requirements for GLP and early-phase GMP environments: all critical process parameters are timestamped and exportable in CSV format. While not pre-certified for FDA 21 CFR Part 11, the architecture allows integration with third-party electronic lab notebook (ELN) systems and audit-trail-enabled data servers upon customer specification.

Software & Data Management

Process data—including temperature ramps, airflow profiles, spray duration, and motor speed sequences—are logged at 1-second intervals and stored locally on an industrial-grade SD card. Export functionality supports USB mass storage mode for seamless transfer to LIMS or statistical process control (SPC) platforms. The embedded control firmware permits creation and recall of up to 99 validated coating protocols, each with password-protected parameter locking. Optional Ethernet port (RS485/Modbus TCP) enables remote monitoring and integration into centralized facility SCADA systems.

Applications

• Enteric coating development per pH-dependent release criteria (e.g., Eudragit® L100/S100, cellulose acetate phthalate)
• Functional barrier layer deposition for moisture-sensitive APIs
• Colored film coating for placebo matching and blinding in clinical trial material production
• Scale-down modeling for commercial pan coating process transfer (QbD-aligned design space exploration)
• Excipient compatibility screening under dynamic thermal-mechanical stress conditions
• Coating uniformity assessment using near-infrared chemical imaging (NIR-CI) sample preparation

FAQ

What is the minimum batch size supported for reliable coating uniformity?

The system achieves consistent film thickness distribution (RSD < 5% by weight gain) at 100 g batches using standard pan geometry; micro-pan configuration extends reliable operation down to 20 g for high-potency compounds.

Can the YC-610 be used for aqueous vs. organic solvent-based coating suspensions?

Yes—the airflow and temperature control range (inlet air: 30–80°C) and adjustable atomization pressure (0.1–0.4 MPa) support both water-based polymer dispersions (e.g., Opadry®) and ethanol/isopropanol solutions (e.g., Eudragit® EPO). Solvent recovery add-ons are available upon request.

Is validation documentation (IQ/OQ) provided with the system?

Factory-issued IQ templates and OQ test protocols are included; site-specific PQ execution and regulatory documentation support can be arranged through Yacheng’s global service network.