Sterilization of Drugs and Devices

Technologies for the 21st Century

Fred M. Nordhauser, Wayne P. Olson

• Publisher: CRC Press
• Year: 2018
• Print ISBN:
  9781574910605
• eBook ISBN:
  9781351413831
• Topic: Médecine
• Subtopic: Pharmacologie

Editors Fred M. Nordhauser and Wayne P. Olson have gathered a team of 18 experts from multi-national and leading edge companies to explore the advantages and disadvantages of current sterilization technologies. They cover the theory behind the technology, the practical concerns of installation from engineering and product development perspectives, the "how to validate" concern, and the pragmatics of implementation in a manner that will satisfy the regulatory agencies. The broad range of in-depth information on numerous technologies will help readers design sterile manufacturing processes cost effectively and efficiently.

Table of contents

• Cover
• Title Page
• Copyright Page
• Table of Contents
• PREFACE
• FOREWORD
• 1. INTRODUCTION
• 2. THE STERILIZATION OF PHARMACEUTICAL SOLUTIONS, WITH EMPHASIS ON THE KINETICS OF THE BACTERIAL DEATH PROCESS
• 3. SIP OF MICROBES IN DEADLEGS
• 4. HEAT PROCESSING FOR THE PHARMACEUTICAL INDUSTRY
• 5. IN-LINE STERILIZATION OF LIQUIDS, FROM THE VIEWPOINT OF FOOD PROCESSING
• 6. STERILIZATION OF MEDICAL PRODUCTS USING GAS PLASMA TECHNOLOGY
• 7. STERILIZING FILTRATIONS: PROCESS
• 8. AIR AND SURFACE STERILIZATION WITH CHEMICALS
• 9. INTEGRATED SYSTEMS FOR THE ASEPTIC FILLING OF STERILE PRODUCT
• 10. GAMMA RADIATION STERILIZATION OF PHARMACEUTICALS
• 11. PUREBRIGHT® PULSED LIGHT STERILIZATION
• 12. VIRUS INACTIVATION AND REMOVAL
• 13. STERILITY TESTING, MICROBIAL MONITORING, AND INJURED ORGANISMS
• 14. PARAMETRIC RELEASE
• INDEX