Medical Device Package Testing

Watch a comprehensive overview of regulatory requirements and testing standards relevant to disinfectant and cleaning validation in pharmaceutical and medical manufacturing. It begins with a comparison of general regulatory expectations from both the U.S. Food and Drug Administration (FDA) and the European Union (EU), highlighting areas of overlap and divergence. A specific focus is placed on FDA regulatory expectations for ensuring effective disinfection practices through validated test methods.

Key segments delve into the role of standardized testing methods, including an overview of ASTM (American Society for Testing and Materials) standards and recent updates to those protocols. These standards ensure consistent, reproducible evaluation of disinfectant efficacy across a range of surfaces and environmental conditions, forming the backbone of regulatory compliance.