Systems Approach to Process Lifecycle Engineering in Pharmaceutical Production

被引：3

作者：

Kawai, Hirofumi ^{[1
]}

Seki, Hiroya ^{[1
]}

Kitajima, Teiji ^{[2
]}

Fuchino, Tetsuo ^{[3
]}

Naka, Yuji ^{[4
]}

机构：

[1] Tokyo Inst Technol, Chem Resources Lab, Midori Ku, Yokohama, Kanagawa 2268503, Japan

[2] Tokyo Univ Agr & Technol, Inst Engn, Koganei, Tokyo 1848588, Japan

[3] Tokyo Inst Technol, Dept Chem Engn, Meguro Ku, Tokyo 1528550, Japan

[4] Techno Management Solut Ltd, Kita Ku, Yokohama, Kanagawa 2220033, Japan

来源：

KAGAKU KOGAKU RONBUNSHU | 2014年 / 40卷 / 03期

关键词：

Pharmaceutical Production Process; Lifecycle Engineering; Activity Model; Quality by Design;

D O I：

10.1252/kakoronbunshu.40.194

中图分类号：

TQ [化学工业];

学科分类号：

0817 ;

摘要：

In pharmaceutical industries, lifecycle management of process improvement by coordinating product design, recipe design, facility development, and production activities is necessary to develop robust and consistent production processes that satisfy requirements for product quality. The business process of pharmaceutical process lifecycle engineering is described in an activity model that defines the stages of plan-do-check-act. On the basis of this model, procedures and a change-management system in lifecycle engineering were developed. The procedures and the system can be continuously improved by the activity model-based systems approach to achieve practicable process lifecycle engineering in pharmaceutical production.

引用

页码：194 / 200

页数：7

共 50 条

[31] DYNAMIC ANALYSIS OF A MICROBIAL PROCESS - SYSTEMS ENGINEERING APPROACH
YOUNG, TB
BUNGAY, HR
BIOTECHNOLOGY AND BIOENGINEERING, 1973, 15 (02) : 377 - 393
[32] An Experimental Approach to Complement Process Systems Engineering Learning
Zemp, Roger J.
Waki, Renata
da Silva, Flavio V.
10TH INTERNATIONAL SYMPOSIUM ON PROCESS SYSTEMS ENGINEERING, 2009, 27 : 2133 - 2138
[33] POLYURETHANEFOAM PROCESS-DEVELOPMENT - SYSTEMS ENGINEERING APPROACH
CAMPBELL, GA
JOURNAL OF APPLIED POLYMER SCIENCE, 1972, 16 (06) : 1387 - &
[34] A critical systems approach to decision support for process engineering
Basson, Lauren
Petrie, Jim
COMPUTERS & CHEMICAL ENGINEERING, 2007, 31 (08) : 876 - 888
[35] PROCESS WEIGHING IN PHARMACEUTICAL PRODUCTION
ZECCHIN, P
CHEMICAL ENGINEER-LONDON, 1987, (438): : 42 - 43
[36] The Design of a Software Engineering Lifecycle Process for Big Data Projects
Lin, Yen-Tai
Huang, Sun-Jen
IT PROFESSIONAL, 2018, 20 (01) : 45 - 52
[37] Perspectives on Process Systems Engineering R&D in Support of Pharmaceutical Product/Process Development and Manufacturing
Reklaitis, Gintaras V. Rex
17TH EUROPEAN SYMPOSIUM ON COMPUTER AIDED PROCESS ENGINEERING, 2007, 24 : 35 - 38
[38] Optimization of the information chain within the engineering process of production systems
Foehr, Matthias
Koehlein, Adrian
Elger, Juergen
Schaeffler, Thomas
Lueder, Arndt
2013 7TH ANNUAL IEEE INTERNATIONAL SYSTEMS CONFERENCE (SYSCON 2013), 2013, : 693 - 698
[39] Modular Process Engineering: Development of Apparatuses for Transformable Production Systems
Lier, Stefan
Paul, Sarah
Ferdinand, Dennis
Gruenewald, Marcus
CHEMBIOENG REVIEWS, 2017, 4 (01): : 60 - 69
[40] Modular Process Engineering: Development of Apparatuses for Transformable Production Systems
Lier, Stefan
Paul, Sarah
Ferdinand, Dennis
Gruenewald, Marcus
CHEMIE INGENIEUR TECHNIK, 2016, 88 (10) : 1444 - 1454

← 1 2 3 4 5 →