Industrial Process Scale-up

A Practical Innovation Guide from Idea to Commercial Implementation

Jan Harmsen

• Verlag: Elsevier
• Jahr: 2019
• ISBN:
  9780444642844
• Auflage: 2
• Thema: Tecnologia e ingegneria
• Thema: Ingegneria chimica e biochimica

Industrial Process Scale-up: A Practical Innovation Guide from Idea to Commercial Implementation, Second Edition helps industrial process innovators in research, development and commercial start-ups assess the risks of commercial-scale implementation, also providing them with practical guidelines and methods to reduce the risks to acceptable levels. In addition, the book can be used in cooperation with industrial R&D people and academic researchers to shape open innovation programs, and in education as a reference book. This updated edition has the latest literature and has been expanded with a scale-up of pharmaceutical processes and their history in both academia and the process industries.

• Offers easily accessible, step-by-step and concise guidelines for industrial process scale-up
• Explains each stage of the innovation funnel, from research, development, demonstration and commercial implementation for any process type and branch
• Based on industrial experiences and practices that reduce the risks of commercial scale implementation of new processes to acceptable levels and reduce cost and time of process innovation

Chapter One

Industrial scale-up content and context

Abstract

This book provides methods and guidelines to industrial process innovators to reduce the chance of failure of novel process implementations to a very low level. To that end, the book uses the following scale-up definition: Process scale-up is generating knowledge to transfer ideas into successful commercial implementations. The book prescribes how that knowledge is generated. The book is intended for all process industries. Specific attention is paid to pharmaceuticals, food, and chemical processes. Process levels and their interactions for scale-up are described. All stakeholders and their roles relevant for innovation projects are described.

Keywords

Industry; Process; Systems; Scale-up; Methodology; Innovation stage-gates; Risks; Knowledge generation

1.1 Purpose and set-up

This book is mainly meant for industrial process innovators. The methods and guidelines provided for them in this book serve three purposes. The first purpose is to provide guidelines so that process innovation projects can be turned into successful commercial scale start-ups, rather than failures. The second purpose is to obtain the best process concept in terms of economics and other criteria, so that the new process is accepted by society and is competitive in the market. The third purpose is to provide guidelines to have innovation project executions that are lowest in cost and in elapsed time.

The need for this book is mainly based on the statistics that 50% of novel process introductions are disasters (Bakker et al., 2014). A disaster, here, is defined as having more than 30% cost growth beyond the budget and more than 38% schedule slippage. The statistics have been gathered from over 12,000 projects from all kinds of process branches by Independent Project Analysis (IPA), as reported by Bakker et al. (2014). Also, mega-scale projects often fail, as reported by Merrow (2011) and Lager (2012). Several projects had not reached design capacity even 5 years after the beginning of the start-up.

The effects of a commercial scale implementation failure for a company can be enormous. It is not only the additional capital investment needed and the revenue losses, but also the loss of trust of clients that the company faces regarding delivering their products as promised. It also means the loss of trust of top management in the innovation power of the company. This can strongly affect the budget for future process innovation projects. Also for technology providers, an implementation failure can have a large negative effect on future sales.

The set-up of this book follows the stage-gate approach. The stage names are obtained from Harmsen (2018). For the first stage, discovery and concept methods and guidelines are presented that ensure that the best concept is identified and selected. In the subsequent stages, methods and guidelines are presented to reduce the risk of implementation to such a low level that start-up cost and start-up times stay within the budget.

Because part of the innovation project failures is due to taking shortcuts of the available guidelines, pitfall warnings are added at each stage-gate chapter. Throughout the book starting with Section 1.3.3, it explains and shows why project innovation shortcuts nearly always end in commercial disasters.

The nature of this book is prescriptive and not descriptive. The guidelines and methods have been proven or are plausible. These guidelines and methods can be used to generate essential design information, to assess risks and to mitigate risks to such a low level that commercial implementation is successful—and the innovation pathway is rapid and efficient. This book also provides real industrial innovation cases with additional learning points. The book is a description of an industrial best practice for scale-up. “An industrial practice is a cooperative human activity in which different professional disciplines work together to develop, produce and sell a product” (Verkerk et al., 2017). Major professional disciplines involved in specific innovation stages are, therefore, mentioned.

The book is intended for industrial process researchers and developers of process industry branches. Special attention in this book is given to pharmaceutical and fine chemical processes for each innovation stage. Furthermore, it will be of use for contract researchers and technology providers to see how and when they can interact with process industry manufacturers and engineering contractors.

The book, however, does not contain descriptions on how to manage and organise industrial research, development, design, and process engineering. It also does not contain detailed process design guidelines for the commercial scale detailed design. For that, the reader is suggested to refer other books on industrial management and process engineering such as Harmsen (2018), Bakker et al. (2014), Dal Pont (2011a, b), and Lager (2010).

1.2 Scale-up definition methodology and risks

1.2.1 Scale-up definition

Often, the term scale-up is used to simply state that a larger production capacity is employed, without any reference to whether this scale-up was successful and how this scale-up was achieved. To also include these elements of scale-up, we use the following definition in this book:

Process scale-up is generating knowledge to transfer ideas into successful commercial implementations.

Knowledge generation involves literature reading, consultation, experimenting, designing, and modelling. The main purpose of this knowledge generation is to be able to assess risks and to reduce risks to acceptable levels for the successful commercial scale implementation. The word “ideas” is stated in this definition rather than “concepts”, as concept generation from ideas is also considered part of the scale-up. Also, the term “scale-up from laboratory scale” is avoided as laboratory experiments are also part of the scale-up knowledge generation.

Successful implementation means that the commercial scale process meets the design targets within the planned start-up time.

The purpose of industrial process scale-up is then mainly risk reduction needed for success. For people working in the process industries, this is a nearly trivial statement and Merrow's book on industrial megaprojects, based on more than 1000 industrial cases, proves that, indeed, in direct commercial implementation without proper industrial research and development, the risks of failure are always too high to take (Merrow, 2011).

For most academics, however, this statement is not trivial at all, because in the academic world the purpose of research is to generate understanding, knowledge, and theory. The word ‘risk’ does not enter in research papers about process innovation and is also not found in process innovation books. Jain et al. (2010) do not contain any description of a goal for innovation. Vogel (2005) and Betz (2011) only state that the goal of industrial research and development is to achieve competitive advantages.

1.2.2 Scale-up methodology

The scale-up methodology of this book is based on knowledge generation for risk identification, risk assessment, and risk reduction. Risk identification of a new process concept is already very difficult, because not all relevant information will be available. If a certain piece of information is not available, then it may be identified as an unknown. But for certain risks even that information may be lacking; I even don’t know what I don’t know. Table 1.1 shows these two different types of knowledge gaps, their associated risks and information plans to close the knowledge gaps.

Table 1.1

Types of knowledge gaps, risks, and knowledge generation plan

Knowledge gap type	Risk type	Knowledge generation plan
I know what I don’t know	Specific and limited	Specific research
I don’t know what I don’t know	Unknown	Integrated process test

Risk identification is, therefore, carried out several times during the innovation project. Each time more information has been generated, more risks items will be identified and consequently risk assessment will improve. If the risks are too high, risk reduction plans wi...

Inhaltsverzeichnis

• Cover image
• Title page
• Table of Contents
• Copyright
• Dedication
• Preface
• Acknowledgement
• Chapter One: Industrial scale-up content and context
• Chapter Two: Discovery stage
• Chapter Three: Concept stage
• Chapter Four: Feasibility stage
• Chapter Five: Development stage
• Chapter Six: Development stage scale-up from existing pilot plants
• Chapter Seven: Implementation stage
• Chapter Eight: Industrial scale-up cases
• References
• Index