Dear all,
can anybody help me about about needs for sterilization of cooling zone in the tunnel? Is there any regulatory for using this specification for new lines? I know that this part is used for isolator lines but what about the “normal” filling lines?
Regards
You have to look Annex 1 and Annex 2 Emea
FDA aseptic guidance.
WHO guidance is also available on these matters.
In all these guidelines the Sterility assurance levels will be discussed and you have to correlate and interpret them.
Since the Tunnel Depyrogenator is a part of total Aseptic processs system, you have to take the comments as a total operation regulation.