In 26 Chapters and over 600 pages this book provides a useful tool towards achieving regulatory compliance.
Since the first edition of this book in 2013 there have been many changes to the approach and methods for cleaning and certifying cleanrooms, most notably the revisions to Parts 1 and 2 of the ISO 14644 series of global cleanroom standards.
In addition to setting out the principal changes in these revised standards, many of the other chapters in the book have been updated to reflect their requirements, bringing current practices and Good Manufacturing Practice regulations up-to-date.
The book also details the leading international cleanroom requirements and regulations: US, FDA, EMA, and ISO. Many of the authors share best practice guidance.
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