2023 ISPE Aseptic Conference Regulatory Panel
ISPE
SEPTEMBER 8, 2023
We hear people discuss the concept of second air. Brooke Higgins Senior Policy Advisor for the Global Compliance Branch 3 FDA/CDER Our guidance does say that integrity testing can be performed prior to processing and that it should be routinely performed post use. Do you align the phrase with the potential to add contamination?
52 
Let's personalize your content