Multi granulation selection criteria

Dear All
Please help in following matter.

We have 4 granulation, 6 compression and 3 packing lines.

in a product matrix we have total 39 products are there.

now my problem is that is there require to do cleaning validation in each area?

awaiting for the responces.

i hope you may all help me out in this matter.

at present we are carried out the CV granulation area wise. means we have four MACO for 4different area.

Pls give your valuable input.


Dear Nimesh,

first a few assumptions: each manufacturing step is physically separated from the others (e.g. granulation is performed in areas different from compression and from packaging). No equipment is crossed between areas (e.g. metal detector used in Compression 1 is never used in Compression 2). Cleaning procedures established per area and not per piece of equipment. All equipment in each area used for all the processes in that area.

Assuming this, the answer to your question is that you need to validate the cleaning procedure for each area, that means you need to validate cleaning procedures for 13 areas. As you will have alternative areas (e.g. granulate from Granulation 1 may be compressed in Compression 2 or Compression 5), probably there will be same worst case for more than one area. Each MACO needs to be calculated taking into account the whole surface, sum of the surfaces from granulation + compression + packaging areas.

If these assumptions are not true, the recommended approach is to validate the cleaning procedure per equipment and not per area.

If you need further assistance on this matter, feel free to ask.

Best regards