Method for reducing environmental, health, and safety risks in active pharmaceutical ingredient manufacturing based on multiobjective evaluation
•Risk-reduction method of a pharmaceutical manufacturing process is developed.•A new indicator is proposed for evaluating the dynamic change of the risks.•Multiobjective evaluation considers risks, economic, and regulatory aspects.•The method is demonstrated in an industrial case study. This work pr...
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| Veröffentlicht in: | Process safety and environmental protection 2016-11, Vol.104, p.304-313 |
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| creator | Segawa, Akiko Yoshikawa, Satoshi Toyama, Takayuki Nakanishi, Hayao Kikuchi-Uehara, Emi Hirao, Masahiko Sugiyama, Hirokazu |
| description | •Risk-reduction method of a pharmaceutical manufacturing process is developed.•A new indicator is proposed for evaluating the dynamic change of the risks.•Multiobjective evaluation considers risks, economic, and regulatory aspects.•The method is demonstrated in an industrial case study.
This work presents a method for assessing and retrofitting the manufacturing processes of active pharmaceutical ingredients (API) considering the risks caused by the environment, health, and safety (EHS), as well as economic and technical aspects. This method consists of four steps: (1) process mass analysis, (2) EHS risk evaluation, (3) generation of improvement options, and (4) multiobjective evaluation and interpretation. A new indicator is proposed as a base for risk evaluation, which considers the dynamic change in process risks as well as the technical countermeasures in the process. The multiobjective evaluation supports the identification of promising improvement options regarding the risk-reducing potential of EHS, economic performance, and the efforts of change management according to Good Manufacturing Practice. A case study was performed in an industrial API manufacturing plant, which includes charging, reaction, filtration, extraction, crystallization, centrifugation, crystal-form conversion, crystallization, filtration, and drying. By following the method step by step, a promising option could be identified that could effectively reduce EHS risks with reasonable efforts in the economic and regulatory aspects. |
| doi_str_mv | 10.1016/j.psep.2016.09.005 |
| format | Article |
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This work presents a method for assessing and retrofitting the manufacturing processes of active pharmaceutical ingredients (API) considering the risks caused by the environment, health, and safety (EHS), as well as economic and technical aspects. This method consists of four steps: (1) process mass analysis, (2) EHS risk evaluation, (3) generation of improvement options, and (4) multiobjective evaluation and interpretation. A new indicator is proposed as a base for risk evaluation, which considers the dynamic change in process risks as well as the technical countermeasures in the process. The multiobjective evaluation supports the identification of promising improvement options regarding the risk-reducing potential of EHS, economic performance, and the efforts of change management according to Good Manufacturing Practice. A case study was performed in an industrial API manufacturing plant, which includes charging, reaction, filtration, extraction, crystallization, centrifugation, crystal-form conversion, crystallization, filtration, and drying. By following the method step by step, a promising option could be identified that could effectively reduce EHS risks with reasonable efforts in the economic and regulatory aspects.</description><identifier>ISSN: 0957-5820</identifier><identifier>EISSN: 1744-3598</identifier><identifier>DOI: 10.1016/j.psep.2016.09.005</identifier><language>eng</language><publisher>Rugby: Elsevier B.V</publisher><subject>Case studies ; Centrifugation ; Change management ; Crystallization ; Drying ; Economics ; Environmental engineering ; Evaluation ; Expert knowledge ; Filtration ; Good Manufacturing Practice ; Hazard ; Hazards ; Health risks ; Manufacturing ; Manufacturing industry ; Multiple objective analysis ; Pharmaceutical industry ; Pharmaceutical manufacturing ; Pharmaceuticals ; Process retrofitting ; Retrofitting ; Risk ; Risk analysis ; Risk assessment ; Risk management ; Risk reduction</subject><ispartof>Process safety and environmental protection, 2016-11, Vol.104, p.304-313</ispartof><rights>2016 Institution of Chemical Engineers</rights><rights>Copyright Elsevier Science Ltd. Nov 2016</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c447t-4dd5a37e2bf81fa257de8445affa018808cb6c9901b1473e75ce58b04230cb783</citedby><cites>FETCH-LOGICAL-c447t-4dd5a37e2bf81fa257de8445affa018808cb6c9901b1473e75ce58b04230cb783</cites><orcidid>0000-0002-3067-030X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S095758201630204X$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids></links><search><creatorcontrib>Segawa, Akiko</creatorcontrib><creatorcontrib>Yoshikawa, Satoshi</creatorcontrib><creatorcontrib>Toyama, Takayuki</creatorcontrib><creatorcontrib>Nakanishi, Hayao</creatorcontrib><creatorcontrib>Kikuchi-Uehara, Emi</creatorcontrib><creatorcontrib>Hirao, Masahiko</creatorcontrib><creatorcontrib>Sugiyama, Hirokazu</creatorcontrib><title>Method for reducing environmental, health, and safety risks in active pharmaceutical ingredient manufacturing based on multiobjective evaluation</title><title>Process safety and environmental protection</title><description>•Risk-reduction method of a pharmaceutical manufacturing process is developed.•A new indicator is proposed for evaluating the dynamic change of the risks.•Multiobjective evaluation considers risks, economic, and regulatory aspects.•The method is demonstrated in an industrial case study.
This work presents a method for assessing and retrofitting the manufacturing processes of active pharmaceutical ingredients (API) considering the risks caused by the environment, health, and safety (EHS), as well as economic and technical aspects. This method consists of four steps: (1) process mass analysis, (2) EHS risk evaluation, (3) generation of improvement options, and (4) multiobjective evaluation and interpretation. A new indicator is proposed as a base for risk evaluation, which considers the dynamic change in process risks as well as the technical countermeasures in the process. The multiobjective evaluation supports the identification of promising improvement options regarding the risk-reducing potential of EHS, economic performance, and the efforts of change management according to Good Manufacturing Practice. A case study was performed in an industrial API manufacturing plant, which includes charging, reaction, filtration, extraction, crystallization, centrifugation, crystal-form conversion, crystallization, filtration, and drying. By following the method step by step, a promising option could be identified that could effectively reduce EHS risks with reasonable efforts in the economic and regulatory aspects.</description><subject>Case studies</subject><subject>Centrifugation</subject><subject>Change management</subject><subject>Crystallization</subject><subject>Drying</subject><subject>Economics</subject><subject>Environmental engineering</subject><subject>Evaluation</subject><subject>Expert knowledge</subject><subject>Filtration</subject><subject>Good Manufacturing Practice</subject><subject>Hazard</subject><subject>Hazards</subject><subject>Health risks</subject><subject>Manufacturing</subject><subject>Manufacturing industry</subject><subject>Multiple objective analysis</subject><subject>Pharmaceutical industry</subject><subject>Pharmaceutical manufacturing</subject><subject>Pharmaceuticals</subject><subject>Process retrofitting</subject><subject>Retrofitting</subject><subject>Risk</subject><subject>Risk analysis</subject><subject>Risk assessment</subject><subject>Risk management</subject><subject>Risk reduction</subject><issn>0957-5820</issn><issn>1744-3598</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><recordid>eNp9kMGO1SAUhonRxOvoC7gicTvtQAsDTdyYiaOTjHGja3JKD3OpLVSgN5m38JHl5rp2AwT-7wc-Qt5z1nLGb2_mdsu4tV1dt2xoGZMvyIErIZpeDvolObBBqkbqjr0mb3KeGWO8U_xA_nzDcowTdTHRhNNufXiiGE4-xbBiKLBc0yPCUo7XFMJEMzgszzT5_CtTHyjY4k9ItyOkFSzuxVtY6sFTLfOVpyuE3dXUns7NI2ScaAx03Zfi4zjjhccTLDvUnfCWvHKwZHz3b74iP-8__7j72jx-__Jw9-mxsUKo0ohpktAr7EanuYNOqgm1EBKcA8a1ZtqOt3YYGB-5UD0qaVHqkYmuZ3ZUur8iHy69W4q_d8zFzHFPoV5pOqYH1ddB1lR3SdkUc07ozJb8CunZcGbO5s1szubN2bxhg6nmK_TxAmF9_8ljMtlWF7YaSfW_Zor-f_hfaZmQiw</recordid><startdate>20161101</startdate><enddate>20161101</enddate><creator>Segawa, Akiko</creator><creator>Yoshikawa, Satoshi</creator><creator>Toyama, Takayuki</creator><creator>Nakanishi, Hayao</creator><creator>Kikuchi-Uehara, Emi</creator><creator>Hirao, Masahiko</creator><creator>Sugiyama, Hirokazu</creator><general>Elsevier B.V</general><general>Elsevier Science Ltd</general><scope>AAYXX</scope><scope>CITATION</scope><scope>7ST</scope><scope>7TB</scope><scope>7U7</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>KR7</scope><scope>SOI</scope><orcidid>https://orcid.org/0000-0002-3067-030X</orcidid></search><sort><creationdate>20161101</creationdate><title>Method for reducing environmental, health, and safety risks in active pharmaceutical ingredient manufacturing based on multiobjective evaluation</title><author>Segawa, Akiko ; Yoshikawa, Satoshi ; Toyama, Takayuki ; Nakanishi, Hayao ; Kikuchi-Uehara, Emi ; Hirao, Masahiko ; Sugiyama, Hirokazu</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c447t-4dd5a37e2bf81fa257de8445affa018808cb6c9901b1473e75ce58b04230cb783</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Case studies</topic><topic>Centrifugation</topic><topic>Change management</topic><topic>Crystallization</topic><topic>Drying</topic><topic>Economics</topic><topic>Environmental engineering</topic><topic>Evaluation</topic><topic>Expert knowledge</topic><topic>Filtration</topic><topic>Good Manufacturing Practice</topic><topic>Hazard</topic><topic>Hazards</topic><topic>Health risks</topic><topic>Manufacturing</topic><topic>Manufacturing industry</topic><topic>Multiple objective analysis</topic><topic>Pharmaceutical industry</topic><topic>Pharmaceutical manufacturing</topic><topic>Pharmaceuticals</topic><topic>Process retrofitting</topic><topic>Retrofitting</topic><topic>Risk</topic><topic>Risk analysis</topic><topic>Risk assessment</topic><topic>Risk management</topic><topic>Risk reduction</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Segawa, Akiko</creatorcontrib><creatorcontrib>Yoshikawa, Satoshi</creatorcontrib><creatorcontrib>Toyama, Takayuki</creatorcontrib><creatorcontrib>Nakanishi, Hayao</creatorcontrib><creatorcontrib>Kikuchi-Uehara, Emi</creatorcontrib><creatorcontrib>Hirao, Masahiko</creatorcontrib><creatorcontrib>Sugiyama, Hirokazu</creatorcontrib><collection>CrossRef</collection><collection>Environment Abstracts</collection><collection>Mechanical & Transportation Engineering Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>Civil Engineering Abstracts</collection><collection>Environment Abstracts</collection><jtitle>Process safety and environmental protection</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Segawa, Akiko</au><au>Yoshikawa, Satoshi</au><au>Toyama, Takayuki</au><au>Nakanishi, Hayao</au><au>Kikuchi-Uehara, Emi</au><au>Hirao, Masahiko</au><au>Sugiyama, Hirokazu</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Method for reducing environmental, health, and safety risks in active pharmaceutical ingredient manufacturing based on multiobjective evaluation</atitle><jtitle>Process safety and environmental protection</jtitle><date>2016-11-01</date><risdate>2016</risdate><volume>104</volume><spage>304</spage><epage>313</epage><pages>304-313</pages><issn>0957-5820</issn><eissn>1744-3598</eissn><abstract>•Risk-reduction method of a pharmaceutical manufacturing process is developed.•A new indicator is proposed for evaluating the dynamic change of the risks.•Multiobjective evaluation considers risks, economic, and regulatory aspects.•The method is demonstrated in an industrial case study.
This work presents a method for assessing and retrofitting the manufacturing processes of active pharmaceutical ingredients (API) considering the risks caused by the environment, health, and safety (EHS), as well as economic and technical aspects. This method consists of four steps: (1) process mass analysis, (2) EHS risk evaluation, (3) generation of improvement options, and (4) multiobjective evaluation and interpretation. A new indicator is proposed as a base for risk evaluation, which considers the dynamic change in process risks as well as the technical countermeasures in the process. The multiobjective evaluation supports the identification of promising improvement options regarding the risk-reducing potential of EHS, economic performance, and the efforts of change management according to Good Manufacturing Practice. A case study was performed in an industrial API manufacturing plant, which includes charging, reaction, filtration, extraction, crystallization, centrifugation, crystal-form conversion, crystallization, filtration, and drying. By following the method step by step, a promising option could be identified that could effectively reduce EHS risks with reasonable efforts in the economic and regulatory aspects.</abstract><cop>Rugby</cop><pub>Elsevier B.V</pub><doi>10.1016/j.psep.2016.09.005</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0002-3067-030X</orcidid></addata></record> |
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| source | Elsevier ScienceDirect Journals |
| subjects | Case studies Centrifugation Change management Crystallization Drying Economics Environmental engineering Evaluation Expert knowledge Filtration Good Manufacturing Practice Hazard Hazards Health risks Manufacturing Manufacturing industry Multiple objective analysis Pharmaceutical industry Pharmaceutical manufacturing Pharmaceuticals Process retrofitting Retrofitting Risk Risk analysis Risk assessment Risk management Risk reduction |
| title | Method for reducing environmental, health, and safety risks in active pharmaceutical ingredient manufacturing based on multiobjective evaluation |
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