Introduction

This introduction presents an overview of the key concepts discussed in the subsequent chapters of this book. The book focuses on the enclosure in which aseptic processing is to be carried out and on the machines used to process the product. It also focuses on common design issues, including dose control, cleanliness, and sterilizable parts, materials of construction, validation, and machine capacity sizing. The book concentrates on liquid filling with a thorough discussion of different types of metering devices. It discusses how each functions as well as the limitations and advantages of representative metering devices and components, such as peristaltic, piston, rolling diaphragm, valves, actuation, gravimetric, time-pressure, manifolds, and filling needles. The book deals with automation of the pharmaceutical or biotech process and focuses on topics such as air-operated valves, automated process piping design, air-operated valve pulsing and sequencing, and U-bend transfer panels.