Combination Products- First Principles for Engineers: Student Edition

By Beverly White

Please note this is the student edition which is presented in a 6" by 9" black and white format. The text is smaller than the full version so some users may wish to purchase the larger edition. This book is a designed to present the integrated nature of engineering, design and development of needle based combination products. Their effectiveness and innovation are powerful illustrations of how patients lives can be improved. However, the challenges associated with them are often based on the cross-functional expertise necessary to provide safe and effective products. The engineering and science of medical devices provides the delivery platform for combination products, while pharmaceutical and biological manufacturers produce medicinal products based on their industries strengths. These constituent parts- device and drug combine to form products that need to be developed and manufactured to ensure they perform, are reliable and robust- this is the language of devices. The therapeutic or drug needs to be pure, safe, effective and uniform- this is the traditional language of the medicinal product. However, this combination creates a third entity effectively. The blending of technologies, materials and interfaces can give rise to new risks and challenges. The integration needs to be verified and demonstrated to not impact the intended use . This book therefore places a large emphasis on risk management of combination devices, usability and the application of design controls that are mandated. Design controls may not be familiar to traditional CGMP/Drug product manufacturers. The various tests for functionality, performance and safety are introduced to the reader. Competent authorities have regulation and guidance covering combination products that is extensively available which the reader is encouraged to access. Therefore, an overview of key concepts and regulatory frameworks provided for context purposes with the design principles and device operating princples the focus. The book illustrates the interdependencies involved in combination products while giving the reading a sound and practical introduction.

• Format: Paperback
• Language: English
• ISBN: B0CZHC2CLV
• ISBN13: 9798321122471
• Release Date: March 2024
• Publisher: Independently published
• Length: 176 Pages
• Weight: 0.71 lbs.
• Dimensions: 9.0" x 0.4" x 6.0"