The bio-pharmaceutical industry demands exacting detail in design, development,
operation, quality, and just about every other aspect of the business.
As such, there is a degree of specialty in most every field of endeavor
in this industry. This book was developed to try to accelerate the learning
process for the application of automation in bio-pharmaceuticals. The
authors' hope is that the content of this book will help scientists and engineers
continue to contribute to the manufacture of high-quality medicines
via improving process control and on-line availability of information
while reducing costs, cycle time, and process variability.
Some readers may come into this industry with previous automation
experience. Others may be in the bio-pharmaceutical industry, but have
limited automation knowledge. In either case, the authors strived to bring
the reader to a more thorough understanding of the topics.
This book is supplemented by a wealth of reference materials in the industry.
Each chapter contains a list of recommended reference materials.
TABLE OF CONTENTS Chapter 1 - Introduction
1.1 Overview
Bio-pharmaceuticals has emerged as one of the most critical industries in
the twenty-first century. Advances in science and medicine have led to
new techniques, new medicines and vaccines with far-reaching impact on
the health of the global population.
Most biological processes have complex and precise requirements for optimal
quality, yield, and production. These requirements may be technical
or regulatory in nature. Both are equally important in ensuring a safe,
effective, and proven process. Proper design and implementation of automation
systems help to ensure a safe, predictable, high quality, and low-cost
supply of the world's vaccines and medications.
This book provides guidance to the engineer who is attempting to apply
automation to bio-pharmaceutical processes. Technical, biological, and
regulatory requirements are addressed. The primary focus is the effect of
these requirements on automation system design and implementation.
