About the Book:
Principles and Practices of Contamination Control and Cleanrooms: A
Comprehensive Guide to Ensuring Safety in Drug Delivery.
Are you a pharmaceutical or biomedical professional seeking to enhance
your understanding of contamination control and cleanrooms? Look no further.
This enlightening book dives deep into the crucial principles and practices
surrounding biosafety and offers invaluable insights for professionals at all
stages of their careers.
With a clear and organized structure, this book caters to readers from
various educational levels, including undergraduate, postgraduate, and doctoral
studies. It is also a valuable resource for expert researchers looking to
generate innovative ideas for more effective drug delivery systems.
Addressing a long-standing industry need, this book provides a cohesive
and up-to-date overview of contamination control, cleanrooms, and biosafety. It
guides readers on how to ensure their facilities, practices, and procedures
align with current norms, setting the stage for success in pharmaceutical and
biomedical disciplines.
A standout feature of this book is its focus on environmental
expectations and testing, exploring the standards set by ISO 14644 for
Cleanrooms and Qualification, ISO 14698 Final Draft International Standards for
Biological Monitoring and Control, the MCA Orange Guide released in December
2002, the USFDA Draft Guidelines for Sterile Drug Products by Aseptic
Processing from September 27, 2002, and the WHO Guidelines for Sterile
Pharmaceutical Preparations. By unraveling the reasoning, procedures, and
implications behind these standards, this book demystifies common
misconceptions in the industry and offers a comprehensive approach to cleanroom
systems and practices.
From foundational concepts to advanced techniques, this book takes
readers on a journey through the intricacies of contamination control and
cleanrooms. Real-life problems are analyzed and solved throughout the book,
bringing theory and practice together in a meaningful way. |