Sterilization Validation and Routine Operation Handbook (2001)

<p>The validation and radiation sterilization process for biomaterials and medical devices requires careful planning to ensure regulatory compliance followed by precise accuracy in execution and documentation. This in-depth guide details all steps from prevalidation planning to final report and ongoing monitoring and control. <em>Sterilization Validation & Routine Operation Handbook: Radiation</em> provides a framework for the validation and routine operation of an irradiation sterilization process. The guidance presented complies with ANSI/AAMI/ISO 11137: 1994 Sterilization of health care product-Requirements for validation and routine control-Radiation sterilization and the newly published AAMI substantiation of 25 kGy using VDmax procedure. The author discusses methods to aid in comprehending the requirements in these standards. She also provides practical procedures for the validation and routine monitoring and control of specific gamma and electron beam radiation sterilization processes.</p>