Handbook of Validation in Pharmaceutical Processes, Fourth Edition

· provides an in-depth discussion of recent advances in sterilization

· identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions

· explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results

· New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture.