A unique requirement for commercial biopharmaceutical process scaleup is process validation. Helps industrial process innovators in research, development and commercial startup to assess the risks of commercialscale implementation and provide them with practical guidelines and methods to this book offers guidelines for industrial process scaleup. Conventional complex process start up with inexperienced personal, novel process design by process synthesis using an expert computer programme and rapid shortcut implementation. Thus, during the scale up efforts in the pilot plant. Pharmaceutical process scaleup, edited by michael levin 119. Technology development benefits from stage gates at which the. Download it once and read it on your kindle device, pc, phones or tablets. A practical guide from idea to commercial implementation this book will help industrial process innovators in. Scaleup definition act of using results obtained from laboratory studies for designing a prototype and a pilot plant process. We try to build industrial size fermenters capable or close of producing the fermentation products as efficient as produced in small. From laboratory to industrial scale scaleup calculations of chemical processes for lca fabiano piccinno1,2 roland hischier1, stefan seeger2, claudia som1 1empa, technology and society lab, st.
The scaleup of chemical processes scientific update. A unique requirement for commercial biopharmaceutical process scale up is process validation. Abstract in this article the authors, based on the visimix software, the experience of visimix users and personal. Basedonrealisticbiology,chemistryandengineeringas sumptions, the team builds process flow diagrams, material. Engineering and scaleup expertise and experience are necessary components to advancing and completing process technology projects safely, on time and on budget. Gallen, switzerland 2university of zurich, department chemistry, switzerland. A chemical plant is an industrial process plant that manufactures or otherwise processes chemicals, usually on a large scale. Read industrial process scaleup a practical innovation guide from idea to commercial implementation by jan harmsen available from rakuten kobo. Dermatological and transdermal formulations, edited by kenneth a.
With a focus on scaleup, this chapter presents a method for riskbased qualification of largescale co 2 absorption processes. Modeling methods the use of several semiempirical modeling methods determines the limitations of your pilot plant scale up through modeling, reducing costs and eliminating the need to build successive test. A practical innovation guide from idea to commercial implementation, second edition helps industrial process innovators in research, development and commercial startups to assess the risks of commercialscale implementation, also providing them with practical guidelines and methods to reduce the risks to acceptable levels. It now also contains information about scaleup methods for pharmaceuticals. Offers easily accessible, stepbystep, and concise guidelines for.
It is a place where the 5 0v like money, material, man, method and machine are brought. For the scale up of chemical processes, shibasaki et al. This book will help industrial process innovators in research, development and commercial startup to assess the risks of commercialscale implementation, isbn 9780444627261 buy the industrial process scaleup. Modeling methods the use of several semiempirical modeling methods determines page 1.
Industrial process scale up capabilities epic process experts. Sustainable industrial process design and scaleup advanced. Microreactors industry perspective industrial design, scaleup, and use of microreactors abstract microreactor technology is currently redefining the way many small molecules are manufactured. Technology development benefits from stage gates at which the viability of the technology can be assessed before continuing with the scale up scaling up step by step t he recommended approach for scaling bioenergy and biofuels technology follows a similar stage gate process to that used in traditional chemical process industry cpi processes. This book will help industrial process innovators in research, development and commercial start up to assess the risks of commercial scale implementation, isbn 9780444627261 buy the industrial process scale up. However, this method requires an lca of a pilot plant and expert knowledge or estimates on how the process will.
It now also contains information about scale up methods for pharmaceuticals. Scaleup projects often require implementation of new equipment or modification of existing equipment. Essential steps basic data process analysis technology choice process modelling industrial unit validation of model scale up mockups pilot plant laboratory source. A practical innovation guide from idea to commercial implementation, second edition helps industrial process innovators in research, development and commercial startups assess the risks of commercialscale implementation, also providing them with practical guidelines and methods to reduce the risks to acceptable levels. A practical innovation guide from idea to commercial implementation, second edition helps industrial process innovators in research, development and commercial startups to assess the risks of commercial scale implementation, also providing them with practical guidelines and methods to reduce the risks to acceptable. Scientific update provides training courses for industrial chemists and chemical engineers in chemical development and scaleup and many other specialist topics. The objective of the course is to give to the students the basis of the scaleup science, through lectures and numerical exercizes using a commercial plant simulation software. The commercial application of technology develop ed in the laboratory to industrial application requires the scaling up from the bench scale. Chemical process scaleup and optimization services for future industrialscale production. Scale up to an industrial process will require large quantities of neutral red crystals, hence an understanding of any polymorphic behaviour is essential for careful control of this process. A practical innovation guide from idea to commercial implementation, second edition helps industrial process innovators in research, development and commercial startups assess the risks of commercial scale implementation, also providing them with practical guidelines and methods to reduce the risks to acceptable levels. An effective process chemical scale up framework will deliver a solution that is fully optimised for safety, capitaloperating costs, capacity, performance and. Pharmaceutical process scaleup deals with a subject both fascinating and vi. With a focus on scaleup, this chapter presents a method for riskbased qualification of largescale co 2.
Production and process controls are evaluated, validated and finalized. Scaleup to an industrial process will require large quantities of neutral red crystals, hence an understanding of any polymorphic behaviour is essential for careful control of this process. Industrial process scaleup organic process research. This book provides industrial process scaleup guidelines and methods. Scale up studies scale up studies are studies carried out at the laboratory or even pilot plant scale fermenters to yield data that could be used to extrapolate and build the large scale industrial fermenters. Dec, 2010 the large size of industrial fermenters required for commercial viability up to 100 m 3 gives rise to problems of mixing, heat transfer, and control as well as problems in physically handling large volumes of liquids and gases. With the tremendous diversity of organisms and products in industrial fermentation, a precise and onesizefitsall strategy for scale up is not. Scale up theory and calculation there are three categories of scale up. These methods are about information generation, risk assessment and risk mitigation to such a low level that commercial implementation is successful and the innovation pathway is. Jan harmsen this book will help industrial process innovators in research, development and commercial startup to assess the risks of commercialscale implementation and provide them with practical guidelines. The first stage is a pilot plant pilot scale with 10010,000 l fermentors and matched downstream equipment. Navigation of industrial emergence barriers, enablers, inhibitors depends on understanding of industry level factors, e.
The concentration of products obtained from biological processes is low typically 10 per cent, so recovery. Related content the chemical development and scaleup of sampatrilat 1. The large size of industrial fermenters required for commercial viability up to 100 m 3 gives rise to problems of mixing, heat transfer, and control as well as problems in physically handling large volumes of liquids and gases the concentration. Industrial process scaleup by jan harmsen overdrive. With the tremendous diversity of organisms and products in industrial fermentation, a precise and onesizefitsall strategy for scaleup is not. Engineering and scale up expertise and experience are necessary components to advancing and completing process technology projects safely, on time and on budget. Advanced sustainable industrial process concept design oct 1 and advanced industrial process scaleup oct 2. Scale up methodology for the fine chemical industry the influence of the mixing in the process moshe bentolila visimix ltd. Industrial process scaleup request pdf researchgate. Tatterson talks largely about the underlying principles of mixing that are often violated in industrial practice starting with the assumption that the two most common configurations of mixing are universally optimal.
Jun 01, 2018 scaling up industrial microbial processes for commercial production is a highstakes endeavor, requiring time and investment often exceeding that for laboratory microbe and process development. Dec 02, 2015 by mark warner, pe, founder, warner advisors llc, special to the digest two questions have dominated the responses received after my lessons learned series on commercializing industrial biotechnology here and the deepdive into the industrial biotechnology commercialization process here, the questions are what makes scale up of industrial biotechnology so difficult and of course how can. A practical innovation guide from idea to commercial implementation kindle edition by harmsen, jan. He focuses in particular on risk reduction and increasing the chances of success. Reference number2 process scale up is the means by which innovations in the chemical industry are put into place in industrial facilities the vast majority of innovations in the chemical process industries are developed at. Normally, all of them wrote in industrial journals. This book will help industrial process innovators in research, development and commercial startup. Scale up projects often require implementation of new equipment or modification of existing equipment. A practical guide from idea to commercial implementation. In the fine chemicals and pharmaceutical industries, the laboratory to semi industrial scale up phase is a critical stage. Scaleup of large industrial processes is preferably done in two stages if there is a high degree of novelty in the process andor the commercial product.
Use features like bookmarks, note taking and highlighting while reading industrial process scaleup. A practical innovation guide from idea to commercial implementation ebook. By mark warner, pe, founder, warner advisors llc, special to the digest two questions have dominated the responses received after my lessons learned series on commercializing industrial biotechnology here and the deepdive into the industrial biotechnology commercialization process here, the questions are what makes scaleup of. Read pdf industrial process scale up free industrial process scaleup 1st edition we also look at specific system challenges based on whether your system is a sanitary process scaleup or an industrial process scaleup. A novel industrial process for the manufacturing of hydromorphone from hydrocodone 4. The scaleup of chemical processes is not such a trivial process and requires a certain understanding of the involved steps. Key factors for bioprocess technology selection, scale up and engineering of new facilities biocatalyst raw materials process technologies products scale economics s cale e conomics b. The cases cover novel single unit operation scale up and conventional complex process scale up. Scale up and chemical process development taking a process or product from the bench to viable production scale is a complex task, often with critical consequences for the process owner. What makes scaleup of industrial biotechnology so difficult.
There are problems associated with all stages of the scalingup of biological processes developed on a laboratory scale. We also look at specific system challenges based on whether your system is a sanitary process scaleup or an industrial process scale up. Technology development benefits from stage gates at which. Process development, engineering and economics by edi d. In october 2014 two new courses will be given by harmsen consultancy in rotterdam. A practical guide from idea to commercial implementation jan harmsen auth. In the fine chemicals and pharmaceutical industries, the laboratory to semiindustrial scaleup phase is a critical stage. Reference number2 process scaleup is the means by which innovations in the chemical industry are put into place in industrial facilities the vast majority of innovations in the chemical process industries are developed at laboratory scale at sizes better suited for careful measurement than for commercial.
This book is a rare combination of high academic standards with practical industrial perspective. Please read our short guide how to send a book to kindle. We apply our unique customercentric project methodology, designbuild approach and unrivaled engineering skills and process scaleup experience to all our projects to build on a. Scaling up industrial microbial processes for commercial production is a highstakes endeavor, requiring time and investment often exceeding that for laboratory microbe and process development. A practical innovation guide from idea to commercial implementation jan harmsen on.
Key factors for bioprocess technology selection, scaleup and engineering of new facilities biocatalyst raw materials process technologies products scale economics s cale e conomics b. A practical innovation guide from idea to commercial implementation, second edition helps industrial process innovators in research, development and commercial startups assess the risks of commercialscale implementation, also providing them with practical guidelines and methods to reduce the risks to acceptable. From laboratory to industrial scale scale up calculations of chemical processes for lca fabiano piccinno1,2 roland hischier1, stefan seeger2, claudia som1 1empa, technology and society lab, st. This paper will focus on the design and scale up strategy of microreactors. Offers easily accessible, stepbystep, and concise guidelines for industrial process scale up. Scale up methodology for the fine chemical industry the.
Industrial design, scaleup, and use of microreactors. Its success will determine the viability of the new products development process under the quality criteria required by the client. The existing focus on the development of postcombustion co 2 capture technologies for carbon capture and storage ccs applications calls for a consecutive scaleup, validation and verification work for the commercialisation of largescale industrial processes. Pharmaceutical process scale up, edited by michael levin 119. Jul 03, 2017 scale up studies scale up studies are studies carried out at the laboratory or even pilot plant scale fermenters to yield data that could be used to extrapolate and build the large scale industrial fermenters.
A practical innovation guide from idea to commercial. Second edition, revised and expanded, edited by allen cato, lynda sutton, and allen cato iii 121. Aug 18, 2014 sustainable industrial process design and scaleup advanced 1day courses by admin 18 august 2014 in october 2014 two new courses will be given by harmsen consultancy in rotterdam. Product reprocessing procedures are developed and validated. Typically the participants are process research and developers, industrial research chemists, process designers, probably active or in a process. Flow charts for the best organization of scale up activities were presented for different authors.