Can we keep two coating pan in one room

Quality Assurance
1

We have reciculated type AHU with hepa filter. Can we keep two coating machine in one room.

2

I wonder, if any specific guideline exists on this subject. The safe answer would be, “no”.

I am tempted to make an exception though. If

  1. the product and batch numbers handled by both the coating pans, is same,
  2. the coating is non-functional (no intended alteration in release profile) and if
  3. the coat colour is not the same as the core tablet colour (eg. while coat on white core tablet)

You may justify putting two coating pans in one room. Let me explain:

Point 1: This needs no elaboration - avoiding inter-batch mix-up/contamination.
Point 2: The usual non-functional coat will be equivalent to 2 to 3% weight gain. Any variation
within this, is not going to make any difference in the tablet property.
Point 3: Any variation of colour coat thickness within the pan and between the two pans, will
be visually apparent, if the colour of the coat and that of core tablets is different.

Now, even if some tablets of one pan accidentally get mixed with that of the other, before the individual pan loads are formally tested and approved; (because after that all pan loads lose their individual identity, anyways!), you lose nothing. There is no risk to the batch or to the patient or to anybody.

That’s what I would call a “risk-based approach” to a specific situation. Hope, you find merit in this.

3

Thank you for the reply. What if we keep a partition between coating pan ? but having same AHU

4

You need to look at the risk involved. What do you achieve by putting up a partition? Without getting too much into the type of partition and all that, you probably avoid physical mix up.

What is the limitation of a common AHU? Cross contamination at chemistry level!

In reply, you can probably go one step further and run the same product two different batches. May be even two different strengths of the same product, assuming the bulk recipe and colours of the coating, remains the same.

You need to evaluate the risk involved. Ask relevant questions and evaluate the “cleanliness” of the answers that you get.

Good luck!