Reproducibility and Robustness in Electrospinning with a View to Medical Device Manufacturing

Abstract

Informed by the numerous theoretical and practical discoveries arising from scientific literature on electrospinning over the last twenty years, coupled with the authors’ considerable industry experience in the field, this chapter examines the realities of engineering reproducible and robust electrospinning manufacturing systems. The development of such systems is discussed around the framework of robust process design, and focuses on the parameters critical to translation of small-scale laboratory-based electrospinning constructs to medium or large-scale production lines. The benefits of well-defined product design specifications, appreciation of desired manufacturing scale, equipment selection, process control and finally quality management systems and regulatory concerns are discussed in such a way that is accessible to those with backgrounds in either laboratory-scale electrospinning or process engineering for medical devices. The viewpoint examined herein remains relatively under-investigated in the electrospinning field, however as the technique continues to mature from a research-based to a true manufacturing technique the challenges addressed below are anticipated to become increasingly important.