Gary Prager – Practical Pharmaceutical Engineering (2019)

4.730 ₽

Автор: Gary Prager
Название книги: Practical Pharmaceutical Engineering
Формат: PDF
Тема: Медицина
Страницы: 565
Качество: Изначально компьютерное, E-book

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

Описание

Gary Prager. Practical Pharmaceutical Engineering — практическое руководство по инженерным аспектам фармацевтического производства. Книга объясняет, как применять принципы химической и биомедицинской инженерии при разработке, масштабировании и эксплуатации производственных процессов лекарственных средств.

Автор подробно рассматривает ключевые темы: проектирование оборудования, управление процессами, валидацию, обеспечение качества, работу с чистыми помещениями, контроль загрязнений и требования GMP. Особое внимание уделено интеграции инженерных решений с регуляторными стандартами современной фармацевтической отрасли.

  • Инженерам-технологам и специалистам по валидации в фармацевтике
  • Студентам и преподавателям профильных специальностей
  • Менеджерам производства и QA/QC, желающим углубить технические знания
  • Всем, кто участвует в разработке и масштабировании фармацевтических процессов

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