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 2 - Hardware and Software
This chapter focuses on design criteria for hardware and software in the
bio-pharmaceutical industry. It centers on the most commonly used
systems in bio-pharmaceuticals.
The first part of the chapter focuses on hardware, including valves, instrumentation,
and transfer panels. This chapter covers the key design and
implementation considerations for each of these devices.
The second half of this chapter discusses software design considerations,
including Good Automated Manufacturing Practices (GAMP), Modular
Design, Skid Integration, and System Architecture.
2.1 General Hardware Design Considerations
Sanitary Design Considerations
Most bio-pharmaceutical equipment is subject to extensive cleaning as
well as steaming for sterilization or bio-burden reduction. Any equipment
that comes in contact with the process must be able to handle exposure to
both caustic and acidic cleaning solutions, as well as direct exposure to
steam.
Even equipment that is not in direct process contact, such as operator
touch-screens and keyboards, are subject to periodic wash-down conditions
within bioprocessing suites.
