Model-Based Robust Parametric Design of Automatic Cleaning Process

被引：0
|
作者：
Petrova, Daniela [1 ]
Koleva, Elena [2 ]
Voutchkov, Ivan [3 ]
机构：
[1] Actavis, Dupnitsa 2600, Bulgaria
[2] Bulgarian Acad Sci, Inst Elect, BU-1784 Sofia, Bulgaria
[3] Univ Southampton, Fac Engn & Environm, Southampton S017 1BJ, Hants, England
来源：
JOURNAL OF PHARMACEUTICAL INNOVATION | 2012年 / 7卷 / 01期
关键词：
Quality by design; Cleaning development; Cleaning validation; Robust parametric design; Statistical modeling; Multiobjective optimization;
D O I：
10.1007/s12247-012-9120-3
中图分类号：
R9 [药学];
学科分类号：
1007 ;
摘要：
The goal of pharmaceutical industry is to manufacture products that meet patients' needs and expectations, while satisfying the regulatory requirements. The products need to meet the required quality and purity characteristics that are represented to possess. Therefore, in a multi-product manufacturing facility, appropriately designed cleaning processes are essential to avoid cross-contamination between products and ensure patients' health and safety. The latest trend in the development of cleaning validation is using quality by design methodology (QbD) to determine the most appropriate parameters of the cleaning processes that will reduce the risks of cross-contamination. The present study highlights the model-based approach for robust engineering design in order to achieve an efficient, reliable, and cost-effective cleaning process simultaneously.
引用
收藏
页码：30 / 37
页数：8
相关论文
共 50 条
  • [1] Model-Based Robust Parametric Design of Automatic Cleaning Process
    Daniela Petrova
    Elena Koleva
    Ivan Voutchkov
    Journal of Pharmaceutical Innovation, 2012, 7 : 30 - 37
  • [2] Design of robust model-based controllers via parametric programming
    Sakizlis, V
    Kakalis, NMP
    Dua, V
    Perkins, JD
    Pistikopoulos, EN
    AUTOMATICA, 2004, 40 (02) : 189 - 201
  • [3] Design of robust model-based tracking controllers via parametric programming
    Sakizlis, V
    Kakalis, NMP
    Dua, V
    Perkins, JD
    Pistikopoulos, EN
    2002 IEEE INTERNATIONAL SYMPOSIUM ON COMPUTER AIDED CONTROL SYSTEM DESIGN PROCEEDINGS, 2002, : 151 - 156
  • [4] Robust Multi-Parametric Model-Based Control
    Pistikopoulos, Efstrations N.
    Kouramas, Konstantinos I.
    Faisca, Nuno P.
    19TH EUROPEAN SYMPOSIUM ON COMPUTER AIDED PROCESS ENGINEERING, 2009, 26 : 297 - 302
  • [5] Robust model-based controllers via parametric programming
    Sakizlis, V
    Kakalis, NMP
    Dua, V
    Perkins, JD
    Pistikopoulos, EN
    EUROPEAN SYMPOSIUM ON COMPUTER AIDED PROCESS ENGINEERING - 12, 2002, 10 : 541 - 546
  • [6] A model-based formulation of robust design
    Al-Widyan, K
    Angeles, J
    JOURNAL OF MECHANICAL DESIGN, 2005, 127 (03) : 388 - 396
  • [7] A model-based framework for robust design
    Al-Widyan, K
    Angeles, J
    Cervantes-Sanchez, J
    RECENT ADVANCES IN INTEGRATED DESIGN AND MANUFACTURING IN MECHANICAL ENGINEERING, 2003, : 431 - 442
  • [8] Design of Regression Model-based Automatic Process Control with Reduced Adjustment Frequency
    Ye, Liang
    Pan, Ershun
    Shi, Jianjun
    QUALITY AND RELIABILITY ENGINEERING INTERNATIONAL, 2009, 25 (08) : 997 - 1013
  • [9] Robust model-based tracking control using parametric programming
    Sakizlis, V
    Dua, V
    Perkins, JD
    Pistikopoulos, EN
    COMPUTERS & CHEMICAL ENGINEERING, 2004, 28 (1-2) : 195 - 207
  • [10] Model-based approaches for robust parameter design
    Kim, DC
    Jones, DL
    COMPUTER AIDED OPTIMUM DESIGN OF STRUCTURES V, 1997, : 507 - 521
12345