To validate the Hot Air Oven process we have used Endotoxin Challenge Vials (ECV’s) to ensure a 3 log reduction. We have never used Biological indicators for this process. Now this has been requested. This is because all other product components are sterilised in the filling room. Given our oven opens in to the filling room, what benefit do BI’s give for vials known to be depyrogenated? Do we need to also prove they are “sterile”.
I doesn’t make sense to me as for depyrogenation tunnels BI testing is not performed as part of validation.