Single Batch Release vs. Full Validation 

Single Batch Release vs. Full Validation 

Single Batch Release vs. Full Validation  Choosing the Right Sterilization Strategy for Your Product Lifecycle  Sterilization goes beyond a regulatory requirement, serving as a critical component of your product’s overall development and commercialization strategy. As...
ISO 10993-1:2026 Changes to Residual Compliance

ISO 10993-1:2026 Changes to Residual Compliance

The End of “One-Size-Fits-All”: Understanding EO Residual Limits in ISO 10993-7:2026 The release of ISO 10993-7:2026 marks one of the most significant changes to ethylene oxide (EO) residual evaluation in decades. For years, manufacturers, laboratories, and regulatory...