This book addresses a long felt need in the industry for coherent information on “contamination control, cleanrooms and biosafety” and offers insights, guidance and assistance to ensure that facilities, practices and procedures are in step with current norms.
The highlight of the book is its focus on the environmental expectations and testing for continued compliance as laid down in :
· ISO 14644 Standards for Cleanrooms and Qualification
· ISO 14698 Final Draft International Standards for Biological Monitoring and Control
· MCA Orange Guide December 2002, just released
· USFDA Draft Guidelines for Sterile Drug Products by Aseptic Processing as released on September 27, 2002
· The WHO Guidelines for Sterile Pharmaceutical Preparations
By explaining the Whys, Hows and Whats, it helps clear myths and misconceptions that abound in the industry, and presents a composite, holistic approach to understanding, analyzing and synthesizing cleanroom systems and practices. Starting from basics the book takes the reader progressively to advanced concepts and techniques that a layman as well as the expert can appreciate and apply the emphasis is centered around real life problems throughout the books.
Whether you belong to Aerospace or Zoonosis, if contamination Biosafety is your concern, this book is for you.