Handbook of Validation in Pharmaceutical Processes

· 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.