Assessment of the Integral Resource Consumption of Individual Chemical Production Processes in a Multipurpose Pharmaceutical Production Plant: A Complex Task

Vorst, Geert Van der; Dewulf, Jo; Aelterman, Wim; Witte, Bruno De; Langenhove, Herman Van

doi:10.1021/ie8015335

Cited by 18 publications

(29 citation statements)

References 19 publications

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“…The setup of this methodology and also tool is visualized in Figure S1, available in the Supporting Information. The methodology to calculate the mass and energy balances of API production processes as presented in Van der Vorst et al 1 and put in Figure S1 in gray is the basis for this new methodology and tool. The modifications allowing environmental impact assessment are presented in Figure S1 in green.…”

Section: A Setup Of the Systematic Resource Evaluationmentioning

confidence: 99%

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A Systematic Evaluation of the Resource Consumption of Active Pharmaceutical Ingredient Production at Three Different Levels

Vorst

Dewulf

Aelterman

et al. 2011

Environ. Sci. Technol.

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In this paper, the development and the advantages of a methodology which allows the systematic assessment of the environmental impact on the resource side of specific pharmaceutical production processes with limited data entry is presented. The quantification of the process-specific mass and energy balances over three different system boundaries (process, gate-to-gate, and cradle-to-gate) is based on the methodology explained in Van der Vorst et al. (Ind. Eng. Chem. Res.2009, 48(11), 5344-5350). These mass and energy balances are now coupled with the thermodynamic term exergy allowing the quantification of the resource efficiency at the process and gate-to-gate level and the environmental impact at the cradle-to-gate level. The advantages of such a calculation tool for the resource evaluation are illustrated with five consecutive pharmaceutical production steps which are part of the galantamine (anti-Alzheimer medication) pathway. It is shown that such a quantitative and systematic evaluation tool allows a detailed and relatively fast evaluation of the resource efficiency of active pharmaceutical ingredient (API) production processes at the three different levels. Combining thermodynamics and the systematic data inventory methodology for the quantification of the resource efficiency first allows results to be merged into a single impact value (exergy loss/mol API or CEENE/mol API) for fast benchmarking and evaluation of different API production processes. Second, it also allows results to be divided over different categories depending on the users' interest and make thorough analysis of processes in order to pinpoint process improvements and quantitatively justify the introduction of second generation production processes or production techniques.

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Section: A Setup Of the Systematic Resource Evaluationmentioning

confidence: 99%

“…1 Chemical developers have to select as early as possible the best ecological and economical process for further development. For this selection procedure, the potential and impact of new processes and technologies are to be quantified, requiring the development of appropriate metrics and indicators.…”

Section: ' Introductionmentioning

confidence: 99%

A Systematic Evaluation of the Resource Consumption of Active Pharmaceutical Ingredient Production at Three Different Levels

Vorst

Dewulf

Aelterman

et al. 2011

Environ. Sci. Technol.

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“…The system was divided into three levels: process level ( ), plant level ( ) and the overall industrial level ( ). 9 As done by Renteria Gamiz et al…”

Section: Product System and System Boundariesmentioning

confidence: 93%

“…A cradle‐to‐gate LCA was performed following the methodology developed by Van der Vorst et al to assess a multipurpose pharmaceutical plant. The system was divided into three levels: process level (α), plant level (β) and the overall industrial level (γ) . As done by Renteria Gamiz et al (unpublished), the plant level (β) is further split into two levels: operating supporting processes (OSPs β′‐1) and conditioning supporting processes (CSPs β′‐2).…”

Section: Methodsmentioning

confidence: 99%

Environmental sustainability assessment of the manufacturing process of a biological active pharmaceutical ingredient

Gamiz

Soete

Heirman

et al. 2019

J of Chemical Tech & Biotech

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BACKGROUND Although the biopharmaceutical market grows rapidly, the environmental impacts of biopharmaceutical manufacturing have been hardly evaluated. The aim of the study is to comprehensively assess the environmental sustainability of a biologically‐produced active pharmaceutical ingredient (API) manufacturing process. For this purpose, an exergy analysis and an (exergetic) life cycle assessment were performed using primary (foreground system) and modeled data (background system). Infliximab, a monoclonal antibody, was considered. RESULTS The fermentation and its raw materials' supply chain was determined to have the highest environmental impact, since the culture media requires chemicals and complex compounds such as animal‐derived materials (ADMs). The total impact per 100 mg of API produced ranged between 18.6 and 101.8 MJex and 2.0–3.1 kg CO2‐eq, mainly as a function of the ADMs' source. A comparison of infliximab and ustekinumab, a biopharmaceutical produced without ADMs, showed that eliminating these materials can reduce the cumulative resource consumption of monoclonal antibody manufacturing by up to 7.5 times. The fermentation is the process taking the longest and the heating, ventilation and air conditioning system which support fermentation areas consumes approximately 75% of all plant electricity use. CONCLUSIONS Culture media nutrients and cleanroom requirements are driving factors in the environmental impact of biological API manufacturing. Obtaining more precise data of the bioprocesses behind these nutrients' supply chain is crucial to corroborating this study's results. © 2019 Society of Chemical Industry

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“…In their joint work, Heinzle et al and Koller et al describe a procedure for ecological and economic assessment during the process design stage for fine chemicals and active pharmaceutical ingredient (API) production in [9,10]. A method for assessing integral resource consumption in a multipurpose API production plant is shown in van der Vorst et al [11]. With the aim of waste minimization, Raymond applied life cycle assessment (LCA) to solvent used in API production, and revealed the importance of solvent recovery regarding cradle-to-grave environmental impacts [12].…”

Section: Introductionmentioning

confidence: 99%

Reducing Energy Consumption in Pharmaceutical Production Processes: Framework and Case Study

2014

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Purpose This paper aims to present a novel framework for reducing energy consumption in pharmaceutical manufacturing processes, with a primary focus on parenterals production. The framework supports (a) the design of optimal energysaving solutions, (b) the execution and implementation and (c) the comparison of designed and actual performance as a postimplementation control. In selecting promising options, multiobjective criteria are defined for comprehensive decision-making which considers not only energy savings, but also other aspects such as good manufacturing practice (GMP), risk, and workers' safety. Methods and Framework In the framework, five phases were defined in total, with three for design and two for execution and control, respectively. In the three design phases, options are generated, evaluated and selected step by step, with appropriate evaluation criteria covering financial as well as non-financial aspects. The roles of various stakeholders, e.g., Operations, Engineering, or Quality Assurance, are defined for each phase in order to enable smooth and certain decision-making. Case Study and Results A case study was performed in the parenterals production plant at Hoffmann-La Roche in Kaiseraugst. Twelve energy efficiency ideas were generated and, after the screening and selection process, the three most promising options from the multiobjective Pareto optimization were implemented to reduce the total plant's energy consumption by 2.5 %. Conclusions The framework enabled the systematic generation and selection of various options, which helped in the allocation of company resources in a prioritized and thus effective manner.

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Assessment of the Integral Resource Consumption of Individual Chemical Production Processes in a Multipurpose Pharmaceutical Production Plant: A Complex Task

Cited by 18 publications

References 19 publications

A Systematic Evaluation of the Resource Consumption of Active Pharmaceutical Ingredient Production at Three Different Levels

A Systematic Evaluation of the Resource Consumption of Active Pharmaceutical Ingredient Production at Three Different Levels

Environmental sustainability assessment of the manufacturing process of a biological active pharmaceutical ingredient

Reducing Energy Consumption in Pharmaceutical Production Processes: Framework and Case Study

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