Sterilization Validation And Routine Operation Handbook

The validation of radiation sterilization of biomaterials and medical devices requires careful attention and precise accuracy in execution, documentation and regulatory compliance. This book provides an in-depth, one-source guide and reference to the subject. All steps from prevalidation planning to final report and ongoing monitoring and control are covered in detail. Procedures are closely linked to applicable and identified regulations and standards. The book brings together in one resource information scattered throughout many documents. Much of the information in this new book is presented in convenient tables and charts. Diagrams and other schematics illustrate equipment.