BFS is considered an advanced aseptic processing technique per FDA guidance documents on sterile filling operations.
This is due to a range of features, such as:
• The forming, filling, and sealing of the container all happen within just seconds of one another. This greatly reduces product exposure,
• The filling zone is entirely inaccessible to operators while the machine is in operation,
• And the filling zone itself is within an ISO 5 environment in both BFS rotary and shuttle machines.