Mr

Ultrasonic spray coating has emerged as a critical technology for applying uniform drug layers in drug-device combination products used in modern medical device therapies. While the technique offers superior control over droplet size, coating uniformity, and material utilization compared with conventional spray methods, translating laboratory-scale coating processes to high-volume manufacturing environments presents significant challenges. Process stability, coating consistency, and throughput requirements must be carefully balanced to maintain product quality in regulated manufacturing settings.

This paper presents a practical approach to scaling ultrasonic spray coating processes from development to production. A structured process development framework was used to identify critical process parameters and evaluate their impact on coating performance. Design of Experiments (DOE) was applied to establish a robust operating window and understand parameter interactions influencing coating uniformity and process stability.

Scale-up considerations, including equipment configuration, process parameter transfer, and throughput optimization, were examined during the transition from development-scale experiments to production-level manufacturing. The results demonstrate how systematic process characterization and data-driven optimization can improve coating consistency while supporting increased manufacturing capacity. Implementation of optimized process conditions resulted in measurable improvements in manufacturing yield and process robustness.

The study highlights key engineering considerations for the successful industrialization of ultrasonic spray coating technologies in medical device manufacturing. The findings provide practical guidance for process engineers involved in new product introduction (NPI) and manufacturing scale-up of drug-coated medical devices.