Tablet Coater

An advanced coating system offering ±3% RSD uniformity in film thickness, precise control over weight gain (2%-30%), and full GMP compliance with real-time monitoring and traceability—ideal for high-quality solid dosage form manufacturing.

This innovative coating system is designed to meet the rigorous demands of pharmaceutical manufacturing, ensuring superior product quality and operational efficiency. The system achieves high uniformity in film thickness (RSD ≤±3%), with a thickness control accuracy of ±0.01mm, guaranteeing consistent content and stability across tablets. It ensures 100% coating coverage without any missed spots, speckles, or bubbles, resulting in smooth and flawless tablet surfaces with an appearance qualification rate ≥99.9%.

The system features excellent atomization performance, producing droplets of uniform size (10-50μm) that thoroughly interact with the tablets, leading to strong adhesion of the coating film (resistant to friction and unlikely to peel off). Precise control over tablet weight gain (2%-30%) with an increment deviation ≤±0.5% meets the weight variation standards set by USP/EP/ChP. During the coating process, there is minimal tablet damage (breakage rate ≤0.1%), thanks to gentle tumbling design, which prevents cracking and disintegration, preserving tablet integrity.

The coating film exhibits excellent density, providing protection against water, moisture absorption, and oxidation, thereby extending the shelf life of tablets (up to 2-5 years at room temperature). Suitable for sustained-release/controlled-release coating processes, the system ensures consistent release rates (release variance ≤±5%), meeting the requirements for targeted drug delivery.

All contact parts are made of 316L stainless steel and PTFE, inert materials with no leachables or adsorption (≤0.1%), complying with USP Class VI standards. Designed with GMP compliance in mind, the system adheres to international regulations such as FDA 21 CFR Part 11 and EU GMP Annex 11, providing tamper-proof electronic batch records (EBR) and full traceability from raw materials to finished products via barcode/QR code linking.

Complete validation documentation (IQ/OQ/PQ), cleaning validation reports, and material compatibility reports facilitate swift GMP certification. The equipment features a smooth surface finish (Ra ≤0.4μm) and supports CIP online cleaning + SIP sterilization at 121°C, avoiding cross-contamination and supporting multi-product line production. International certifications like CE, ISO 9001, ASME BPE enable global deployment in solid dosage form facilities, reducing compliance risks.

Efficiency is another hallmark, with production rates ranging from 5kg/batch to 500kg/batch, suitable for small-scale trials, intermediate stages, and commercial production. Modular expansion supports capacity upgrades. Adjustable parameters include coating pan speed (10-60rpm), airspeed (1-10m/s), and temperature (30-80°C), precisely matching different material characteristics. Customizable spray gun numbers (1-6 guns) support multi-angle spraying, enhancing uniformity for large capacities and irregular-shaped tablets. Integrated preheating, drying, and cooling functions reduce material transfer steps, preventing secondary contamination and boosting production efficiency.

Equipped with a PLC + touchscreen control system, the coating machine supports manual/automatic mode switching, enabling unattended operation in automatic mode. Over 100 preset coating recipes can be quickly accessed, modified, and stored, with encryption options to prevent unauthorized access to process parameters. Real-time visualization monitors coating status (temperature, airspeed, spray volume, tablet weight gain), supporting remote monitoring and operation via mobile or desktop devices, enhancing management efficiency. Fault diagnostics automatically identify issues such as nozzle blockages, temperature limits exceeded, and abnormal airspeed, triggering audible/visual alarms and recording fault information. Comprehensive safety features—overload protection, anti-scald protection, explosion-proof design (Ex d IIB T4 optional), emergency stop buttons—ensure operator and equipment safety.

Key components—nozzles, fans—are sourced from renowned brands, ensuring long service life and low failure rates, supporting continuous production. Low maintenance costs, minimal wear parts, and detailed maintenance manuals/videos reduce operational barriers and enhance equipment utilization.

CategorySpecification / Feature
Film Thickness UniformityRSD ≤±3%; thickness control accuracy ±0.01mm
Coating Coverage100%; no missed spots, speckles, or bubbles
Atomization PerformanceDroplet size 10-50μm; strong adhesion
Tablet Weight Gain Control2%-30%; increment deviation ≤±0.5%
Tablet IntegrityBreakage rate ≤0.1%; avoids cracking and disintegration
Film DensityWater-resistant, moisture-proof, antioxidant; extends shelf life up to 2-5 years
Release Rate ConsistencySustained/controlled release; release variance ≤±5%
Material Compatibility316L SS, PTFE; no leachables; protein adsorption ≤0.1%; USP Class VI compliant
Regulatory ComplianceGMP, FDA 21 CFR Part 11, EU GMP Annex 11
Data IntegrityEBR with immutable data storage; audit trail enabled
TraceabilityFull chain traceability via barcode/QR linking
Validation SupportIQ/OQ/PQ documentation, cleaning/validation reports
Clean DesignRa ≤0.4μm; CIP capable + SIP sterilization
International CertificationsCE, ISO 9001, ASME BPE
Production Range5kg/batch – 500kg/batch
Adjustable ParametersCoating pan speed (10-60rpm), airspeed (1-10m/s), temperature (30-80°C)
Spray Gun Numbers1-6 guns; supports multi-angle spraying
Integrated FunctionsPreheating, drying, cooling
Control SystemPLC + touchscreen; manual/auto modes
Recipe Management100+ presets; quick modification; storage, encryption
Real-Time MonitoringTemperature, airspeed, spray volume, tablet weight gain
Fault DiagnosticsAuto-detects nozzle blockages, temperature limits exceeded, abnormal airspeed
Safety FeaturesOverload, anti-scald protection, explosion-proof design (Ex d IIB T4 optional), emergency stop
Component QualityInternationally branded nozzles, fans
MaintenanceLow cost; minimal wear parts; detailed manuals & video guides

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