Validating dedicated equipment

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?:confused:

dear mr part,

If I understand you correctly the kits are different in design. In that case I would recommend to use the worst case for each kit as you do need to prove your chosen cleaning method will work for the different designs.


Yes sir, the kits are different in design, so that makes sense to me–now do I need to calculate the surface area of all the pieces or just the two worst case pieces?

b.t.w., that’s Miss Terror :smiley: I play roller derby; it’s my derby name.

Here’s another question:

Since the FDA says:

“When the cleaning process is used only between batches of the same product (or different lots of the same intermediate in a bulk process) the firm need only meet a criteria of , “visibly clean” for the equipment. Such between batch cleaning processes do not require validation.”

Since each of our trains are dedicated and we clean after the use of each kit within 2 hours of use, does this mean we don’t even have to validate our cleaning process? or am I misreading this information?

Dear Terror A. Part,

although you are not exactly misreading this information, there are three points to consider:

The first point is that in the same document, it is stated that it refers only to chemical residues, so the micro part still needs validation, and that it states too that “Of course, the main rationale for requiring clean equipment is to prevent contamination or adulteration of drug products”, so it includes degradation products which may have a toxicity high enough to render the “visually clean” criteria inacceptable.

The second point is that you need to prove that each and every part of the equipment can be inspected for residues, (no inaccessible parts in the equipment), and is actually inspected prior to reassembling after cleaning.

The third point is that setting analytical limits for contamination with chemical residues is only one way to validate a cleaning method. In your case the acceptance criteria could be reduced to visual cleanliness of each part of the equipment.

Best regards