Broadening Conformance for VHP Sterilization: New Insights for Regulatory and Applications

The work for developing new international industry standards has been successfully moving forward, with the purpose to add new standards further specifying requirements for VHP sterilizer equipment and indicators. This presentation discusses these latest developments as well as looks at new implications and how the overall developing sterilization related requirements are aligning with what we are seeing where the pharmaceutical industry is going from better risk assessment, process trending, monitoring, verification and validation perspectives.

As the use of VHP sterilization is continuously expanding its footprint within the pharmaceutical and medical device industries, there is also scientific work ongoing for confirming process compatibility for various applications, materials and solutions. This results in a frequent stream of publications of case studies and research articles, and some of the latest information is shared.

This presentation can benefit medical device and packaging developers, engineers, decision makers, product owners, manufacturing, process, validation and quality control leaders.