Extractables & Leachables Testing Regulations, Test Strategies and Industry Direction


Thursday, October 19, 2017 from 1:00 PM to 2:00 PM EDT
This is an online event.
For more information, contact Deb Carbone of Boston Analytical at (603) 212-5307

Extractables & Leachables regulations have been expanding and changing over the past five years. These changes have brought some clarity to the Pharmaceutical industry, however a lot of confusion exists in the marketplace.

The current regulations, best practices and test approaches will be reviewed, followed by an in-depth discussion of Single Use Systems (SUS). SUS are comprised of manufacturing components that are designed for use in a single manufacturing run or cycle, and then discarded.

The Pharmaceutical industry has been working to develop protocols for characterizing SUS, specifically how to appropriately screen them for extractables & leachables.

End users have also been working to harmonize test approaches to allow for data comparison amongst Single Use Systems, and also to define where responsibility in the supply chain lies for this testing. These include the BPOG Protocol, USP draft chapter <665>, and the BPSA SUS E&L Guideline.

This talk will conclude with strategies for compliance to these methods/protocols.