Flush Studies to Review the Leachable Safety Risk of a Filter in the Drug Product Manufacturing Process
Posted on December 18, 2022
Jéssica Marques, Senior Scientist – Trace Analysis and E&L, Petra Booij, Investigator – Trace Analysis and E&L, Rachel Collier, Analytical Chemist – Trace Analysis and E&L, GSK
Abstract A filter is used close to the end of the manufacturing process to sterilize the drug product (DP) before filling into syringes. An Extractable and Leachable (E&L) risk assessment was performed, and the filter was scored as a potential high risk of leachables ending up in the DP due to t...
To read the full article and other articles in this issue, please register for a free account or log in.
We will not sell or give your information to a third party. See our Privacy Policy
Subscribe to our FREE newsletter and WEBINAR UPDATES
We will not sell or give your information to a third party. See our Privacy Policy
