Tablet Compression - Increasing Batch Size and Multitip tooling

Hi All,

We currently have validated tablet compression for a particular product for a batch size of 1 million and using single station press. We are looking to increase to a batch size of 4 million using multi tip tooling, we are also looking to compression 1 million batch size using the multi tip tooling.

I suggested that in order to validate the new process we do 3 batches of the 4 million batch size and 1 batch of the 1 million batch size. This would be after doing a smaller scale trial batch.

Others within the organisation are suggesting that 1 batch of the 1 million tablets batch size and 1 of the 4 million batch size would be sufficient, however I feel that since we have no experience of multi tip tooling that by validating the largest batch size that we would be covered for the smaller batch sizes.

I would like people’s opinion on a suitable approach.


Hi Dee
If you are doing Tablet press qualification then just do the validation of machine covering all of its operating and functional range it should not be based on the particular product. Yes If you are doing product process validation then you can consider the actual batch size for the product process to be validated and obviously all the manufacturing equipment to be used in the process should be qualified. If you select the highest batch size then you are covered for smaller one.