Here
is the most important text discussing aseptic and sterile manufacturing to be
published in the last decade that looks at both today and tomorrow in regard to
these two vital processing procedures.
The
Editors realized that there was an urgent imperative for the relevant subjects
to be reassessed and represented. To achieve this objective, along with many
subject matter experts, they produced a book that is foremost practical. It has
been designed for those involved with aseptic and sterile processing to take
away many learning points and apply these principles to aseptic and sterile
processing within the pharmaceutical and healthcare sectors.
Drawing
on experience, they made every effort to incorporate sound science into the
practices described, not least to emphasize why new paradigms are required but
to provide wide-ranging guidance and offer depth and scope. This is why
chapters on human error, risk assessment, depyrogenation, bioburden testing and
so on, are extensively covered. It is the aim of the Editors to help readers
reassess legacy definitions and historical understandings and move them toward
concepts that will help them think in new ways about equipment and processes
that will reach the highest standards and evaluate them through science-based
risk assessments.
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology
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