1. Executive Summary
A major pharmaceutical manufacturer specializing in diabetes medications needed to scale production of Metformin hydrochloride—one of the world’s most prescribed oral antidiabetic APIs. Their challenge: achieving consistent coarse micronization (D99 ≤ 150 μm) at an industrial throughput of 480 kg/h, without compromising particle uniformity or process stability. Epic Powder’s MQW20 Fluidized Bed Jet Mill was selected to replace their conventional metformin grinding system, resulting in enhanced control, higher yield, and reliable continuous operation.
2. The Production Challenge
Metformin’s effectiveness depends on controlled particle size distribution to ensure predictable dissolution and bioavailability. The manufacturer faced:
- Throughput limitations – Existing equipment could not sustainably exceed 300 kg/h without particle size variability.
- Precision requirements – A strict D99 of 150 μm was needed to maintain batch-to-batch consistency.
- Flowability and handling – Coarser, uniform particles were essential for direct compression in high-speed tableting lines.
3. Why the MQW20 Was Selected
The MQW20 combines robust construction with intelligent airflow and classification design, making it ideal for high-volume API processing:
- Advanced Dynamic Classifier – Provides precise top-size control, ensuring no particles exceed the 150 μm threshold.
- High-Capacity Grinding Chamber – Optimized nozzle geometry and chamber volume enable stable operation at 480 kg/h.
- Temperature-Safe Processing – No heat generation from mechanical parts, preserving Metformin’s chemical stability.
- Easy Scalability & Cleaning – Designed to meet pharmaceutical GMP standards, with quick turnaround between batches.
4. Verified Performance Outcomes
After installation and process optimization, the MQW20 delivered:
- Throughput: Sustained output of 480 kg/h with continuous 24/5 operation capability.
- Particle Size Control: Consistent D99 ≤ 150 μm, with steep PSD curves for excellent flowability.
- Process Efficiency: 30% higher energy efficiency per kilogram compared to the previous system.
- Operational Uptime: Reduced downtime due to no screen blockage or overheating issues.
5. Conclusion
The MQW20 has enabled scalable, precise, and economical micronization of Metformin—proving that high throughput and tight particle control can coexist in API manufacturing. For producers of high-volume oral solid dosage APIs, the MQW20 offers a reliable, GMP-ready pathway to increased capacity without sacrificing quality.
Ready to Scale Your API Milling Process?
Contact Epic Powder to arrange a material test and discover how the MQW20 can optimize your production of Metformin or other high-volume pharmaceuticals.