ISA-88 Implementation Experiences
ISA-88 Implementation Experiences
ISA-88 Implementation Experiences
WBF Foreword xv
Preface xix
17 Quest for the Perfect Batch: A Batch Distillation Real Life Case 201
Index 289
vi | CO NTENTS
1.3. EM phases. 5
vii
7.10. MFD. 84
7.11. TFD. 84
viii | F IG URES
10.3. Bivariate scores plot for latent variable 3 versus latent variable 4. 120
10.11. Time series plot of mean levels resulting in distinct clusters in the
PC1 versus PC2 score plot. 126
11.1. Example of a transfer panel. Note the ports and U-bends. 132
11.2. Upstream and downstream tank linked with a transfer line and
single valve. 133
11.4. Transfer line with upstream and downstream transfer panels. 134
FIGU R E S | ix
13.2. Architecture after replacing the first controller with a new ISA-88.01
compliant unit and adding a new HMI “II” with batch management. 152
13.3. Architecture after replacing the entire control system for the “X” line. 152
13.5. Architecture of the unified HMI with batch management over both
the newer and legacy controllers. 154
x | F IG URES
17.2. Overall strategy in using the PAIP methodology (process noise diagram). 206
17.7. Comparing analysis and improvement before and after institution of PRF. 216
17.8. Comparing before, after, and last half of the first year of PRF. 217
17.11. Comparing before, after, last half of first year, and second year of PRF. 221
17.12. Average batch time changes resulting from PRF development. 223
17.13. All batch times: Changes resulting from PRF development. 226
FIGU R E S | xi
21.4. Example of batch or phase monitoring from within an HMI package. 267
xii | F IG UR ES
1.1. Case study one: Time savings for implementation tasks, in hours 8
1.2. Case study two: Time savings for implementation tasks, in hours 9
xiii
The purpose of this series of books from WBF, The Organization for Production
Technology, is to publish papers that were given at WBF conferences so that a
wider audience may benefit from them.
The chapters in this series are based on projects that have used worldwide
standards—especially ISA-88 and 95—to reduce product variability, increase pro-
duction throughput, reduce operator errors, and simplify automation projects. In
this series, you will find the best practices for design, implementation, and opera-
tion and the pitfalls to avoid. The chapters cover large and small projects in a wide
variety of industries.
The chapters are a collection of many of the best papers presented at the North
American and European WBF conferences. They are selected from hundreds of
papers that have been presented since 2003. They contain information that is rel-
evant to manufacturing companies that are trying to improve their productivity and
remain competitive in the now highly competitive world markets. Companies that
have applied these lessons have learned the value of training their technical staff in
relevant ISA standards, and this series provides a valuable addition to that training.
The World Batch Forum was created in 1993 as a way to start the public edu-
cation process for the ISA-88 batch control standard. The first forum was held in
Phoenix, Arizona, in March of 1994. The next few years saw growth and the ability
to support the annual conference sessions with sponsors and fees.
The real benefit of these conference sessions was the opportunity to network
and talk about or around problems shared by others. Papers presented at the con-
ferences were reviewed for original technical content and lack of commercialism.
Members could not leave without learning something new, possibly from a field
thought to be unrelated to their work. This series is the opportunity for anyone
unable to attend the conferences to participate in the information-sharing network
and learn from the experiences of others.
ISA-88 was finally published in 1995 as ISA-88.01-1995 Batch Control Part 1:
Models and Terminology. That same year, partially due to discussions at the WBF con-
ference, ISA chartered ISA-95 to counter the idea that business people should be
able to give commands to manufacturing equipment. The concern was that business
xv
xv i | W BF FO REWO R D
xvii
Twenty-one of the chapters in this book were selected from WBF conference papers
because they were related to the implementation of batch control in one way or
another. In addition, the editor has added a twenty-second chapter on material
transfers that was not previously presented at a WBF conference because several
of the other chapters demonstrate the need for a standard on models and terminol-
ogy for transfers.
It is the need to use recipes to create products that complicates batch process
design. In the bad old days (or good if you were a custom systems designer), there
was no consistent set of models and terminology for turning recipes into processes.
Vendors and users evolved their own ways of describing batch process control.
This gave way to a “Tower of Babel” situation. The need for standard models and
terminology grew with each new system and each new generation of designers.
The ISA Standards and Practices Board created ISA88 in 1988. A small (and
changing) group of ISA committee members hammered out, not to say word-
smithed, a standard that was originally based on Tom Fisher’s 1990 ISA book Batch
Process Control. Ideas were submitted, reviewed, discussed, refined, and finally put
into a format suitable for an international standard.
Often, the proponent of a new idea had to educate the group so that they
would understand why it was a good idea. The separation of recipe and equip-
ment procedures was one of those ideas. It eliminated specific hardware references
in recipe procedures, at a time when nearly everyone was used to putting hard-
ware references into their recipes. The drawback of this methodology was that the
recipe had to be changed if the equipment was improved or replaced. Generally,
there are lots more recipes than pieces of equipment, and recipes have to be revali-
dated for food and pharmaceutical processes. This made recipe systems expensive
to implement and maintain. The new model eliminated all of these problems.
Many outside the committee were unaware of the usefulness of the new ideas.
Some were aware but did not fully understand how to use them. Some went ahead
and built systems anyway, claiming compliance with the standard. The WBF was
formed to address the education problem by providing a forum for control experts
to present and share their knowledge and demonstrate, through real projects, the
advantages of using the ISA-88 models.
xix
xx | P REFACE
How a Flexible
Batch Application
Can Save Costs
J. Gordon Roney
Control Systems Group Leader
[email protected]
Noramco, Inc., 1440 Olympic Drive,
Athens, GA 30601, USA
Andrew Blankenship
Integration Engineer
[email protected]
Innovative Controls, Inc.,
624 Reliability Circle, Knoxville, TN 37932, USA
Abstract
This chapter is a case study of the implementation of batch-capable Equipment
Modules (EMs) at an existing facility that manufactures Active Pharmaceutical
Ingredients (API) that can be used with or without a batch manager application.
In 2004, we started the process of expanding a recently installed process control
system. We desired the ability to reuse EMs in order to save costs on system con-
figuration, qualification, and new recipe configuration. Additionally, we wanted
the capability to use these EMs independent of the batch manager application.
The EMs resided in the controllers instead of at the batch management level,
which allowed us to configure and qualify them independent of any higher-level
recipe manager. Cost savings resulted from being able to qualify them once and
Introduction
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But the ISA-88.01 model that best addressed the requirements was yet to be decided.
Further evaluation of the requirements resulted in the following EM control
options: direct control by the operator, control via a higher-level operation, and
control via the batch application manager. In all of the EM control options listed,
the ability to select the needed EM, the appropriate EM control strategy, and the
input parameters for the control strategy and a means to monitor and control the
EM once execution was under way was needed. Since the batch application man-
ager was not going to be implemented in the first phase of the process control
system installation, the ability for the operator to control the EM independent of
the batch application manager clearly became the driving force in determining the
appropriate ISA-88.01 model.
Control” would be developed. This template would not have links to subordinate
CMs. Each individual application based on the EM template would have the links
to subordinate CMs.
The first major implementation activity was the introduction of CM templates.
By defining, developing, and qualifying CM templates, the links needed by EMs
would be predetermined and consistent (Fig. 1.2).
The next major implementation activity was the introduction of EM tem-
plates. Creating a new EM template is a multiple-step process. The first step is
4 | THE W BF BO O K S ERIES : VO L U M E 1
template. A change is implemented and tested once at the EM template, and the
functionality is propagated to each instance of the EM template.
Another important aspect of implementing EMs at the controller level is
related to the safe, normal operation of equipment. The response of the EM to an
initiating event or events that warrant the subordinate CMs to assume a predes-
ignated state can be implemented and tested prior to the implementation of the
batch application manager. It is important to note that this functionality does not
serve the functionality of a safety-instrumented system.
Most if not all EMs that have been implemented to date have a dedicated phase
called “safe” for this predetermined state. Initiation of this phase can be internal to
the EM, via operator initiation of the “safe” phase, or initiated externally to the EM
itself (Fig. 1.5). Examples of these external events include the shutdown of a unit,
power loss, cascaded unit shutdowns, and so on. When the “safe” phase is called
upon to execute, the EM will execute the predetermined actions. By monitoring and
responding to initiating events at the controller level directly, the response time can
be reduced as compared to EMs hosted on a server-based batch application manager.
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Cost Savings
Pharmaceutical manufacturers, like most other manufacturing companies, under-
take the standard activities of engineering configuration, preimplementation
testing, and operational testing when implementing control systems and new con-
trol strategies. Unlike other manufacturing companies that do not operate in an
FDA-regulated environment, pharmaceutical manufacturers must undertake the
following additional activities when implementing control systems and new con-
trol strategies:
The extensive hours and expenses associated with these tasks make the reuse of
EMs, support documentation, and testing extremely appealing.
It should come as no surprise that the largest investment of time, and therefore
expense, comes in the development of the first instance of the EM. Once the first
instance is created and qualified, subsequent instances do not need to be function-
ally qualified to the extent of the original model. In contrast, if no EM templates are
used, then complete testing of functionality must be undertaken because no defined
template has been qualified. Two case studies comparing the initial EM implementation
to a subsequent implementation of the same type are detailed in the following sections.
These examples demonstrate the cost savings afforded by controller-based EMs.
Table 1.1. Case study one: Time savings for implementation tasks, in hours
Task Original Second Saved
Requirements and 24 8 16
specifications
Qualification 80 51 29
documentation
Engineering 73 37 36
configuration
Preimplementation 12 8 4
testing
Total 189 104 85
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Table 1.2. Case study two: Time savings for implementation tasks, in hours
Task Original Second Saved
Engineering 178 80 98
configuration
Preimplementation 32 16 16
testing
Total 210 96 114
■ It has been far easier to deal with problems early on rather than dur-
ing the production startup of a recipe. In practice, it has been useful
to have operators manually execute EM logic, catch control logic
obstacles before recipe implementation, and address them.
■ Having EM logic within the controller has allowed the flexibility to
use EMs to recover from a batch application manager failure.
■ Recipe development has been simplified. If the production process
has been automated to the EM level, then the development of a
recipe is greatly facilitated. This is the result of the operating instruc-
tions being written at the EM level.
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