About
the book:
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. |