This book is essential for anyone associated with the cleanroom industry.
In 26 Chapters and over 600 pages this book provides a unique tool to help you achieve regulatory compliance. It first creates a foundation in history and established practice and then helps you understand how state of the art technology and engineering solutions can deliver the best practice and so provide reliable systems performance.
Captures in a single volume all aspects of cleanroom operations – from how to select disinfectants to conducting airflow studies, and from commissioning cleanrooms to building isolators. The book also embraces pharmaceutical cleanrooms, hospital pharmacies and laboratory clean air devices.
Since the first edition of this book in 2013, there have been many changes to the approach and methods for cleaning and certifying cleanrooms, most notably the revisions to Parts 1 and 2 of the ISO 14644 series of global cleanroom standards. In addition to setting out the principal changes in these revised standards, many of the other chapters in the book have been updated to reflect their requirements, bringing current practices and Good Manufacturing Practice regulations up-to-date. The book also details the leading international cleanroom requirements and regulations: U.S., FDA, EMA, and ISO. Many of the authors share best practice guidance.
The chapters on isolators and other barrier devices, contain added information about vapour phase bio-decontamination using hydrogen peroxide. There are also updates to those chapters surveying the future of aseptic processing and cleanroom technology, with a special focus on areas like automation.
This updated edition will prove an essential resource to all practitioners involved in the operation and management of cleanrooms.
Chapter 1: Introduction
Chapter 2: History and Development of Cleanrooms
Chapter 3: Cleanroom Standards and GMP Requirements
Chapter 4: Design and Construction of Pharmaceutical Cleanrooms
Chapter 5: Air Handling Systems for the Protection of Pharmaceutical manufacturing Processes
Chapter 6: Cleanrooms in Hospitals
Chapter 7: Commissioning and Qualification of Cleanrooms
Chapter 8: Cleanroom Certification and Ongoing Compliance
Chapter 9: Fundamental of Pharmaceutical Isolators
Chapter 10: The Choice of Isolator: A Risk-Based Decision
Chapter 11: Validation Concepts in Pharmaceutical Aseptic Application Isolators
Chapter 12: Risk-based product and Occupational Exposure Control in Built-Product facilities
Chapter 13: Future of Aseptic Processing
Chapter 14: Aseptic process Simulations/Media Fills
Chapter 15: Microbial Risk Management During Aseptic Manufacture
Chapter 16: Airflow Studies and Airflow Mapping
Chapter 17: Cleanroom Containment Sources and Control Measures
Chapter 18: Particle Counters and Particle Counting
Chapter 19: Environmental Monitoring in Cleanrooms
Chapter 20: Cleaning and Disinfection practices
Chapter 21: Cleanroom Clothing
Chapter 22: Quality Assurance in Hospital Pharmacies
Chapter 23: Building management Systems for Cleanroom process Parameters Monitoring and Control
Chapter 24: Energy management and Sustainable Cleanrooms
Chapter 25: Auditing Cleanroom Operations
Chapter 26: Developments in Cleanroom Technology