Beschreibung:
An in-depth, one-source guide and reference, Sterilization Validation & Routine Operation Handbook: Radiation provides a framework for the validation and routine operation of an irradiation sterilization process. All steps from pre-validation 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 author discusses methods to aid in comprehension of the requirements in these standards. Much of the information in this book is presented in convenient tables and charts. Diagrams and other schematics illustrate equipment.
Rationale for Validating Sterilization Processes. Characterization of Radiation Processes. Contract Sterilization. Prevalidation Planning. Microbiological Considerations. Sterilization Support Testing. The Validation Protocol. Outline of the Sterilization Validation. Final Report. Routine Monitoring and Control. Appendices. Glossary. Bibliography.