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Books > Professional & Technical > Industrial chemistry & manufacturing technologies > Industrial chemistry > Pharmaceutical technology
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Cleaning Validation Manual - A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries (Paperback)
Loot Price: R3,620
Discovery Miles 36 200
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Cleaning Validation Manual - A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries (Paperback)
Expected to ship within 12 - 19 working days
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During the past decades, enormous progress and enhancement of
pharmaceutical manufacturing equipment and its use have been made.
And while there are support documents, books, articles, and online
resources available on the principles of cleaning and associated
processing techniques, none of them provides a single database with
convenient, ready-to-use training tools. Until now. Cleaning
Validation Manual: A Comprehensive Guide for the Pharmaceutical and
Biotechnology Industries elucidates how to train the man power
involved in development, manufacturing, auditing, and validation of
bio pharmaceuticals on a pilot scale, leading to scale-up
production. With over 20 easy-to-use template protocols for
cleaning validation of extensively used equipments, this book
provides technical solutions to assist in fulfilling the training
needs of finished pharmaceutical manufacturers. Drawing on the
authors' more than two decades of experience in the pharmaceutical
and biotech industries, the text offers hands-on training based on
current approaches and techniques. The book does not merely provide
guidelines or thought processes, rather it gives ready-to-use
formulas to develop Master Plan, SOPs, and validation protocols. It
includes cleaning procedures for the most commonly used equipment
in various manufacturing areas and their sampling points, using a
pharmaceutical manufacturing site with both sterile and non-sterile
operations as the case facility. It also provides the training
guidelines on downloadable resources to enable users to amend or
adopt them as necessary. Grounded in practicality, the book's
applicability and accessibility set it apart. It can be used as a
guide for implementing a cleaning validation program on site
without the help of external consultants, making it a resource that
will not be found collecting dust on a shelf, but rather, referred
to again and again.
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