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.
Chapter 3.4 - Steam-In-Place: SIP
SIP Process Description and Challenges
The Steam-In-Place (SIP) System is responsible for repeatedly steaming
areas of product contact, including vessels, flow paths, and sample ports.
This may be done to reduce the bio-burden on the system, or to kill harmful
materials at the end of a batch.
A typical SIP system will ensure that all areas being steamed have been
exposed to live steam for an adequate time to ensure the desired "kill"
effect.
The steam system must be able to measure and control steam temperature,
pressure, and/or flow to ensure adequate steaming. Calculation of Fo
or other measures is often required to meet process needs.
The SIP sequence usually involves the following steps:
- Path confirmation
- Purge of non-condensables
- Steaming
- Cool-down
- Hold in steamed state
These sequences are covered in more detail below.
TABLE OF CONTENTS