1st Edition
by Gary Prager (Author)
A practical guide to all key the elements of pharmaceuticals and biotech manufacturing and design
Engineers
working in the pharmaceutical and biotech industries are routinely
called upon to handle operational issues outside of their fields of
expertise. Traditionally the competencies required to fulfill those
tasks were achieved piecemeal, through years of self-teaching and
on-the-job experience—until now. Practical Pharmaceutical Engineering
provides readers with the technical information and tools needed to
deal with most common engineering issues that can arise in the course of
day-to-day operations of pharmaceutical/biotech research and
manufacturing.
Engineers working in pharma/biotech wear many
hats. They are involved in the conception, design, construction, and
operation of research facilities and manufacturing plants, as well as
the scale-up, manufacturing, packaging, and labeling processes. They
have to implement FDA regulations, validation assurance, quality
control, and Good Manufacturing Practices (GMP) compliance measures, and
to maintain a high level of personal and environmental safety. This
book provides readers from a range of engineering specialties with a
detailed blueprint and the technical knowledge needed to tackle those
critical responsibilities with confidence. At minimum, after reading
this book, readers will have the knowledge needed to constructively
participate in contractor/user briefings.
- Provides
pharmaceutical industry professionals with an overview of how all the
parts fit together and a level of expertise that can take years of
on-the-job experience to acquire
- Addresses topics not covered in university courses but which are crucial to working effectively in the pharma/biotech industry
- Fills
a gap in the literature, providing important information on
pharmaceutical operation issues required for meeting regulatory
guidelines, plant support design, and project engineering
- Covers
the basics of HVAC systems, water systems, electric systems,
reliability, maintainability, and quality assurance, relevant to
pharmaceutical engineering
Practical Pharmaceutical Engineering
is an indispensable “tool of the trade” for chemical engineers,
mechanical engineers, and pharmaceutical engineers employed by
pharmaceutical and biotech companies, engineering firms, and consulting
firms. It also is a must-read for engineering students, pharmacy
students, chemistry students, and others considering a career in
pharmaceuticals.