Mostrando resultados por autor "Brendan Cooper" en Todas las categorías

This concise book is broadly divided into 3 parts. The first part introduces the standard ISO 13485 and Quality management systems. Part two then examines the key area of Design controls and there application to medical devices. Finally, a review of Quality Risk management is provided. In the first instance, providing safe and effective medical devices depends on a sound basis’ of design. However, how we see and rate risks also impacts the safety of products produced. A holistic approach to medical device manufacturing ensures Quality from design conception to commercial manufacturing. ...

CGMP, Current Good Manufacturing Practices has legal and practical implications for manufacturers of medicinal products and medical devices. The requirements to meet CGMP is legal requirement but it also ensures the patient receives products that are safe, effective and of consistent quality. The FDA, WHO, ICH, PIC/s AND Eudralex provide extensive guidance and regulations on many topics related to the manufacture of medicinal and drug products. A large body of reference materials is available to manufacturers and engineering professionals. This book brings together the key requirements of ...

Biotechnology brings together many fields of expertise including engineering, chemistry, microbiology to mention a few. This paperback book provides a overview of the key themes and requirements of Aseptic processing and sterile manufacturing. It is written in a simple and plain style and provides a practical approach under standing the technologies used within the industry. Chapter 1: Facilities Chapter 2: Clean Utilities Chapter 3: Sterile Manufacturing Operations Chapter 4: Depyrogenation Chapter 5: Cleaning and Disinfection Chapter 6: Process Development Chapter 7: Physical Processes ...

This book provides a short introduction to Depyrogenation, Isolators and Aseptic Filling. The information is presented in simple language in order to make the material accessible and readable. It provides a concise and compact resource for Engineers and Scientists working within Biotechnology. While there a many book titles, guidance standards and reference books, there format does not allow for logical or practical reading. This book introduces key concepts in Aseptic processing and aims to provide the reader with knowledge that can be applied in industry. Perfect for those new to Aseptic ...