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📖 Description
Stringent regulations require govern validate sterilization processes. This series provides step-by-step guidelines to develop and implement a validation program. Each handbook explains standard procedures and protocols and furnishes details on support tests. ISO standards requirements for validation, microbiological methods, EtO residuals, and parametric release are covered. This series will be a tremendous benefit for all quality assurance/sterilization specialists, specialists in medical device companies, packagers of medical devices as well as analytical chemists and manufacturing engineers.