Choosing The Right PCD Configuration For Reliable Sterility Assurance (White Paper)

Selecting the right Process Challenge Device (PCD) configuration is essential for achieving reliable sterility assurance in EO sterilization of medical devices and IVD products. Gain practical insights into how internal and external PCDs support validation strategies, emphasizing the importance of aligning PCD resistance with the most challenging sterilization scenarios. This white paper explains why an 8-log spore reduction (SLR) is a more accurate benchmark for complete kill than the commonly assumed 6-log, and walks through the overkill method, D-value calculations, and ISO 11135 compliance requirements. Discover how to choose between different BI formats and PCD types, including self-contained biological indicators (SCBIs), and best practices for consistent handling and load configuration.

Explore the full white paper to refine your sterilization strategy and ensure regulatory confidence.