Granulator

This advanced granulation system is designed to meet the rigorous demands of the pharmaceutical industry, ensuring high levels of product quality and operational efficiency. The system excels in particle size uniformity, achieving a Relative Standard Deviation (RSD) ≤5% and allowing precise control over particle sizes ranging from 0.1mm to 5mm, which ensures optimal flow properties for subsequent tablet pressing or capsule filling processes.

The granule strength can be adjusted to ensure a friability ≤1%, providing excellent wear resistance that prevents breakage during transportation and processing, thereby enhancing product stability. Materials are mixed with a uniformity ≥99.5%, ensuring even distribution of Active Pharmaceutical Ingredients (APIs), and meeting content uniformity standards set by USP/EP/ChP.

Precise moisture control (±0.2%) through real-time monitoring and hot air regulation avoids both excessive drying and moisture absorption, while the low fine powder rate (≤3%) minimizes material waste and reduces the need for additional sieving steps, improving raw material utilization. The system also boasts excellent repeatability, with batch-to-batch variations in particle characteristics (size, density, flowability) kept within ≤2%, ensuring consistent product quality.

Designed with GMP compliance in mind, the system meets international regulations such as FDA 21 CFR Part 11 and EU GMP Annex 11, providing tamper-proof electronic batch records (EBR) and supporting full traceability from raw materials to finished products via barcode/QR code linking. Complete validation documentation (IQ/OQ/PQ), cleaning validation reports, and material test reports are provided to facilitate smooth GMP certification.

The system supports various granulation processes including wet granulation (high-speed mixing granulation, fluid bed granulation), dry granulation, and spray granulation, accommodating a wide range of materials from powders and crystals to traditional Chinese medicine extracts and thermosensitive substances. It handles capacities from 5kg/h to 1000kg/h, making it suitable for pilot, intermediate, and commercial-scale production.

With PLC + touchscreen controls, the system offers both manual and automatic modes, enabling unattended operation in automatic mode. Over 100 preset granulation recipes can be quickly accessed and modified, with support for encryption to prevent unauthorized access to process parameters. Real-time monitoring and remote control enhance management efficiency, while built-in fault diagnostics minimize downtime by automatically identifying issues like motor failures, screen blockages, and temperature limits exceeded.

Safety features include overload protection, anti-scald protection, emergency stop buttons, and optional explosion-proof designs (Ex tD A21). Low maintenance costs, extended component life (e.g., screens lasting ≥1000 hours), and detailed maintenance manuals and video tutorials reduce operational barriers.