Cleanrooms are one of the most critical components of lifesciences industry and their efficient running and top quality, ensure satisfying the company management as well as the regulatory agencies. Due to the large number of critical parameters that need be controlled at all time, management of cleanrooms acquires much more attention than other non-sterile operations.
This book for the first time, brings together experts in this field to cover this subject in an exhaustive manner and provide the reader with all-encompassing information and latest cutting-edge technology at their finger tips in one complete volume. The chapters are written by acknowledged international experts from companies involved in every aspect of cleanroom management, each providing practical advice and information. The book helps you understand how state of the art technology and engineering solutions can deliver the best practice and so provide reliable systems performance.
It begins by explaining in depth, the various international regulatory and GMP standards governing cleanrooms, followed by detailed feature study of design and construction of cleanrooms and especially HVAC, the critical heart of all cleanrooms. Also included in the book is information on their qualification and commissioning as well as certifications.
A very in-depth study is provided in the book on Isolators and their validation. Asceptic processing technology with latest international trends is covered in a comprehensive manner. The detailed contents below will give the reader the complete picture of cleanrooms that is covered in this book. provides a unique tool to help you achieve regulatory compliance. |
