scholarly journals Correction To: Case Study in the Design of a Surrogate Solution for Use in Biopharmaceutical Drug Product Process Development

2021 ◽  
Vol 22 (2) ◽  
Author(s):  
Kevin Boksa ◽  
Peter Walsh ◽  
Ambarish Shah
2009 ◽  
Vol 382 (1-2) ◽  
pp. 23-32 ◽  
Author(s):  
Jun Huang ◽  
Goldi Kaul ◽  
Chunsheng Cai ◽  
Ramarao Chatlapalli ◽  
Pedro Hernandez-Abad ◽  
...  

AAPS Open ◽  
2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Madalena Testas ◽  
Tiago da Cunha Sais ◽  
Leonardo Piccoli Medinilha ◽  
Katia Nami Ito Niwa ◽  
Lucas Sponton de Carvalho ◽  
...  

AbstractThe use of a Quality by Design (QbD) approach in the development of pharmaceutical products is known to bring many advantages to the table, such as increased product and process knowledge, robust manufacturing processes, and regulatory flexibility regarding changes during the commercial phase. However, many companies still adhere to a more traditional pharmaceutical process development—in some cases due to the difficulty of going from a theoretical view of QbD to its actual application. This article presents a real-world case study for the development of an industrial pharmaceutical drug product (oral solid dosage form) using the QbD methodology, demonstrating the activities involved and the gains in obtaining systematic process and product knowledge.


2016 ◽  
Vol 5 (2) ◽  
Author(s):  
Vinod N. Sambrani

India is a country which is in forefront of being called a developed nation. To be a developed nation, India has to first look at its rural development, because 70 percent of the population live in rural areas, which means more than 700 million people are spread across 6,27,000 villages. Rural development is more than ever before linked to entrepreneurship. Establishments and agencies promoting rural development now look at entrepreneurship as a strategic development medium that could speed up the rural development process. Development institutions believe that rural entrepreneurship offers a huge potential for employment. In this paper a case study of a young entrepreneur who has taken up horticulture (vegetable plants nursery) as his full time profession, with a mission to help the neighbouring farmers is studied, the purpose of this paper is to understand the government role (policies and schemes), the difficulties faced by the entrepreneur during the startup time and knowledge transfer from the horticulture department, nursery management. The methodology followed is in-depth interaction with the entrepreneur. The outcome of paper will be to understand how rural entrepreneurship is helping improve the quality of life for families, communities and individuals leading to sustainable economy and environment.


2018 ◽  
Vol 44 ◽  
pp. S132-S133
Author(s):  
Z. Findrik Blaževic ◽  
M. Sudar ◽  
I. Dejanovic ◽  
M. Müller ◽  
Ð. Vasic-Racki

2004 ◽  
Vol 15 (3) ◽  
pp. 238-246 ◽  
Author(s):  
Sauli Karvonen ◽  
Juhani Rämö ◽  
Mauri Leijala ◽  
Jan Holmström

Author(s):  
Simon Rauch ◽  
Frank Piepenbreier ◽  
Dorothea Voss ◽  
Jakob Albert ◽  
Martin Hartmann
Keyword(s):  

2015 ◽  
Vol 2015 (1) ◽  
pp. 000413-000418
Author(s):  
Wenjuan Qi ◽  
Daniel D. Evans

Modern wedge bonders have evolved since their early inception in 1957. This paper will review the common challenges process engineers face when selecting a wedge bond machine configuration and developing robust processes. Wedge bond cases presented will show the tradeoff between process inputs and the resulting bond shapes, bond appearance of black ring, burrs, pull results, etc. The purpose of this work was to optimize the process outputs: bond shape, black ring, burrs, and pulls on a die with aluminum bond pads. Process inputs included Force, Time, and Ultrasonic Level. An aluminum wafer was used to understand the basic relationship between process parameter inputs and outputs. The learning was then applied to a die with aluminum bond pads. Examples of non-compliance and compliance will be shown to help process engineers evaluate wedge bonds and make refinements. The case studied was for an aluminum bond pad/Al wafer and 1.5 mil aluminum wire interaction that creates burrs around the bond (wire to pad interface), black ring on the bond periphery (wedge tool to wire interface) and the resulting pulls. Both the graphical and numerical results of the case study have clearly demonstrated the relationship between the typical process inputs and outputs, particularly bond shape, burrs, black ring and pulls. The findings in this study will provide a general guideline and a troubleshooting reference for wedge bonding process development.


Sign in / Sign up

Export Citation Format

Share Document