ABSTRACT

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. Sterilization Validation

chapter 2|14 pages

CHARACTERIZATION OF RADIATION PROCESSES

chapter 3|6 pages

CONTRACT STERILIZATION

chapter 4|20 pages

PREVALIDATION PLANNING

chapter 5|14 pages

MICROBIOLOGICAL CONSIDERATIONS

chapter 6|14 pages

STERILIZATION SUPPORT TESTING

chapter 7|4 pages

THE VALIDATION PROTOCOL

chapter 8|22 pages

OUTLINE OF THE STERILIZATION VALIDATION

chapter 9|2 pages

FINAL REPORT

chapter 10|6 pages

ROUTINE MONITORING AND CONTROL