Hi, would you consider HVAC system for secondary packaging a direct impact system? I didn’t think so, as it would not affect the product; but the room classification is ISO 8. And in the guideline, one of the criteria for Direct impact system is: “is the system subject to GMP or regulatory requirement or used to demostrate compliance with a registered process?”. Would classifying the room as ISO 8 makes it requiring qualification, or do you think commissioning is enough?