USP <665> insights: How cutting-edge extractables & leachables analytics can improve patient safety

Webinar

USP extractables and leachables (E&L) guidelines on single-use (SU) assemblies went effective this past May. The guidelines are grounded in a risk assessment process that aids in the study design to ensure that the product and device compositons, as well as the processing conditions are considered to ensure a robust extractables data set. By using a range of analytical methodologies, the full extractables profile can then be used to determine patient safety as worst-case leachables, or a more targeted leachables study can be designed.

This talk will focus on the critical parts of the guidelines and our methods, aiming to make them more approachable and implementable.

In this webinar, you will learn:

• E&L overview from a single-use perspective
  
• typical types of analytical methods used
  
• the USP risk assessment process
• how extractables results guide the next steps of leachables and patient safety