In nearly 600 pages this is a start-to-finish manual of cleanroom design, maintenance, operation and safety. This new edition addresses every hurdle and hoop you face, from agencies in the US, the EU, the ISO, and beyond.
The book included includes information on the following aspects:
- Technical issues including engineering, contamination risk and microbiology
- The ins and outs of air-handling systems and airflow studies
- Building and validating isolators
- Selecting the proper disinfectants for cleanrooms
- Using the right cleanroom clothing
- Conducting proper environmental monitoring
However, there is more to cleanroom GMP than technical issues:
- Discover how to conduct cleanroom audits
- Learn best practices and systems you can rely on
- Understand the science behind contamination control.
It’s all in this single practical volume.
A work of this scope and authority calls for a global team of experts. Editors Tim Sandle and Madhu Raju Saghee draw on the talents of 19 specialists from the U.S., Europe, and Asia, and contribute chapters of their own.
In 26 chapters, Cleanroom Management in Pharmaceuticals and Healthcare covers every aspect of cleanrooms, from basic standards and GMP requirements to innovations in cleanroom technology.
With proper guidance, your cleanrooms will transform from Achilles heel to the strongest link in your drug manufacturing chain. Cleanroom Management in Pharmaceuticals and Healthcare is the tool to help you accomplish this.
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