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 3.6 - Clean Steam
Process Description and Challenges
Clean steam generation and distribution is a fairly straightforward
process. Steam is generated from a pure water source and then distributed
throughout the facility. Each usage point for steam typically has a steam
trap for condensate removal.
Typical Instrumentation Requirements
Temperature measurement is required at some use points. Be sure to consult
with Sterility Assurance personnel to determine the requirements for
temperature measurement. Thermocouples or RTDs are most often used.
Steam pressure regulation is also required. Typically, spring-driven steam
pressure regulators are used. Care must be taken to avoid dead spots in the
design of steam pressure regulators and steam trap locations.
Sample points will likely require point-of-use condensers. It is typical that
these systems are instrumented with local gauges and manual valves only,
so there is little automation.
Monitoring or recording of steam use may be required. Mass flow meters
are generally the best solution for this. Be sure to choose a design and
location that will not create a problem with condensate build-up.
Control Strategies
Communications
Clean steam generators are typically supplied as a packaged unit with its
own dedicated control system. Distribution systems typically have a
custom-built steam distribution system. There is little valving or instrumentation;
it is possible that all steam distribution valves and instruments
can be "owned" by the unit operation that is drawing the steam. This
greatly simplifies the design, testing, and validation.
Sequences
Steam generation is carried out continuously. Additional sequences may
be supplied for system maintenance.
Steam distribution is a single, continuous operation.
Control Loops
Steam pressure control maintains the system pressure. Of course, relief
valves are required to prevent over-pressure.
Calculations
There are no calculation concerns for clean steam.
Tuneables
If you have a large clean steam distribution system, you may have a common
header, with smaller local headers supplying parts of the operation.
In this case, it is common to put a smaller steam regulator at each of these
branch headers. You will want to tune the regulators so that a single operation
does not starve the main header.
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