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 a CD-ROM 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.
General
Is the information for this product incomplete, wrong or inappropriate?
Let us know about it.
Does this product have an incorrect or missing image?
Send us a new image.
Is this product missing categories?
Add more categories.
Review This Product
No reviews yet - be the first to create one!