Автор: Kevin Williams
Название: Microbial Contamination Control in Parenteral Manufacturing
Издательство: CRC Press
Год: 2004
ISBN: 978-0824753207
Серия: Drugs and the Pharmaceutical Sciences (Book 140)
Язык: English
Формат: pdf
Размер: 10,8 mb
Страниц: 764
Parenteral drugs require sterility in every case: there is no gray area in that regard. What, then, is the relevance of “contamination control” in parenteral manufacturing? Contamination control occurs at a multitude of sites along the series of processes that lead invariably to the final result that is a sterile product. Any highly specialized, multidisciplinary endeavor must of necessity be viewed from many perspectives.
Each chapter in this book represents a facet, an expert perspective, of the control of contaminants in parenteral manufacturing. It is the product of a diverse and international group of experts. It is an effort not merely to describe the multitude of activities involved in the manufacture of parenteral products, but to capture the theory, essence, and pitfalls associated with an endeavor that occurs in an environment in sharp contrast to almost all other earthly activities.