James Agalloco – författare

Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of pharmaceutical and bio-pharmaceutical production processes. Handbook of Validation in Pharmaceutical Processes, Fourth Edition is essential for all global health care manufacturers and pharmaceutical industry professionals.Key Features:Provides an in-depth discussion of recent advances in sterilizationIdentifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutionsExplores distinctive and specific process steps, and identifies critical process control points to reach acceptable resultsNew chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture

Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of pharmaceutical and bio-pharmaceutical production processes. Handbook of Validation in Pharmaceutical Processes, Fourth Edition is essential for all global health care manufacturers and pharmaceutical industry professionals.Key Features:Provides an in-depth discussion of recent advances in sterilizationIdentifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutionsExplores distinctive and specific process steps, and identifies critical process control points to reach acceptable resultsNew chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture

The preparation of sterile products using aseptic processing is considered perhaps the most critical process in the pharmaceutical industry and has witnessed continual improvement over the last half century. New approaches that have transformed classical aseptic production methods are appearing almost daily. This book reviews emerging technologies for aseptic processing that will markedly reduce the level of contamination risk for sterile products and includes coverage on:The use of isolator and barrier concepts for aseptic processing and assembly.The application of robotics as an alternative to gowned personnel.The increasing reliance on automation to minimize or eliminate operator intervention.The design, operational, monitoring and compliance changes necessary for success with advanced aseptic processing.Advanced Aseptic Processing Technology is an essential reference for anyone working with sterile products, and is recommended for individuals in manufacturing,, compliance, regulatory affairs, microbiology, environmental monitoring, sterility testing, sterilization, validation, engineering, development, facility and equipment design, component and equipment suppliers, automation, and robotics.