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 pharmaceutical coating development in R&D and formulation laboratories. Designed around the core principle of fluidized-bed-assisted pan coating, it integrates controlled rotational motion, programmable hot-air circulation under negative pressure, and real-time adjustable spray atomization to deliver reproducible, uniform film coatings—including immediate-release, sustained-release, and pH-dependent enteric coatings—on tablets, capsules, and mini-tablets. Its architecture conforms to fundamental unit operations defined in USP & Ph. Eur. monographs for tablet coating, supporting early-stage process development aligned with ICH Q5A–Q5E and Q8(R2) guidelines. The system operates as a closed, GMP-compliant miniaturized platform where thermal, mechanical, and fluid-dynamic parameters are independently regulated to emulate scalable production conditions while minimizing material consumption (100–400 g/batch).

Key Features

• 7-inch color touchscreen interface with integrated PLC control, enabling real-time monitoring and adjustment 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 design inside the stainless-steel coating drum (standard Ø210 mm, customizable) ensures extended residence time and laminar tumbling trajectories—enhancing coating homogeneity and reducing edge wear on fragile cores
• Adjustable pneumatic fan nozzle with on-the-fly spray fan-angle modulation, allowing optimization of droplet dispersion profile across variable batch sizes and drum geometries
• Dual-zone airflow management: conical inlet and bottom-exit ducting improve thermal exchange efficiency and minimize localized overheating or moisture retention within the bed layer
• Dedicated micro-tablet drum option available for sub-3 mm dosage forms, addressing challenges in coating integrity and adhesion for high-surface-area particles
• Patented anti-sliding agitator geometry prevents core aggregation and wall adhesion during low-volume runs, maintaining consistent tumbling dynamics even at 100 g loads
• Smart spray gun with integrated needle purge function; purge frequency and duration fully configurable via HMI; automatic feed cutoff if atomization pressure falls outside user-defined thresholds (±0.02 MPa)

Sample Compatibility & Compliance

The YC-610 accommodates conventional compressed tablets (4–12 mm), gelatin and HPMC capsules, sugar-coated pellets, and mini-tablets down to 1.5 mm diameter. Its sealed drum design meets ISO 14644-1 Class 7 cleanroom compatibility requirements when operated in controlled environments. All wetted parts are constructed from AISI 316L stainless steel and food-grade PTFE seals, compliant with USP extractables testing protocols. Process data logging supports audit-ready documentation for GLP and pre-GMP studies. While not certified for commercial manufacturing, its parameter mapping capability aligns with FDA’s Stage 1 Process Validation expectations for lab-scale equipment used in formulation scouting.

Software & Data Management

The embedded control system records timestamped values for all 12 monitored variables at 1-second intervals, exporting CSV files directly to USB storage. Data structure follows ASTM E2500-22 Annex A2 standards for raw process data archiving. Optional OPC UA integration enables connection to enterprise MES or LIMS platforms. Audit trail functionality complies with ALCOA+ principles: attributable, legible, contemporaneous, original, accurate—with electronic signatures enabled for SOP-driven workflows. No cloud dependency; all data remains on-device unless explicitly exported.

Applications

• Enteric coating development using Eudragit® L100, S100, or cellulose acetate phthalate (CAP) formulations
• Functional film coating for taste masking, moisture barrier enhancement, or light protection
• Process parameter screening (e.g., inlet air temp vs. drum speed vs. spray rate) to establish design space per ICH Q8(R2)
• Stability-indicating coating trials under accelerated humidity/temperature stress conditions
• Compatibility testing between API-excipient-coating polymer systems prior to pilot-scale transfer
• Training platform for coating technician certification programs adhering to PIC/S PE 009-14 Annex 15 standards

FAQ

Is the YC-610 suitable for regulatory submission batches?

No—it is intended strictly for non-GMP research and development. Final validation batches require full-scale, 21 CFR Part 11-compliant equipment.

Can the system be validated per IQ/OQ protocols?

Yes. Factory-supplied IQ/OQ templates are provided, covering sensor calibration traceability (NIST-traceable thermocouples, pressure transducers), airflow verification (anemometer-based), and HMI logic testing.

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

Empirical testing confirms ≥150 g yields RSD <3% for weight gain distribution (n=6), assuming proper drum loading ratio (30–40% volume fill).

Does the unit support solvent-based or only aqueous coating formulations?

Both. Explosion-proof optional upgrades (ATEX Zone 2) are available for organic solvent use (e.g., ethanol/isopropanol blends).

How is cleaning validation supported?

Drum and spray assembly are fully dismountable; surface area calculations and swab sampling points are documented in the User Manual per PDA TR29 principles.