We have a very small manufacturing facility with five lines of production. Each of the lines have dedicated equipment of approximately 11 pieces of equipment in each.
Some of the lines (2 in particular) have “kits” that are used on different days. ex: On day one of production, use kit one and two. On day two of production, use kit 3. The product never returns to any piece of previously used kit.
I have a few questions pertaining to cleaning validation:
Do I choose the two worst cases out of each train or do I choose the two worst cases out of each kit?
Do I need to calculate the surface area of every piece in each train, or only those two worst case pieces identified?