Gamma Irradiation Sterilization Validation for Single-Use Systems
This study validates gamma irradiation sterilization methods for single-use bioprocessing systems, demonstrating effective sterility assurance using VDmax27.5 method.
Abstract: This paper addresses the validation and ongoing monitoring of gamma irradiation sterilization for single-use bioprocessing systems. Using the VDmax27.5 method, the study established a sterilization dose range of 27.5-45 kGy, achieving a Sterility Assurance Level (SAL) of 10-6.
The validation encompassed multiple product families and incorporated comprehensive bioburden testing, with results averaging 1284.8 CFU/device. Regular quarterly dose audits and rigorous process monitoring ensure consistent sterilization effectiveness across two qualified irradiation facilities. The study demonstrates sustained sterility validation through systematic bioburden monitoring, dose mapping, and verification testing, establishing a robust framework for single-use system sterilization.