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.
Thanks
Dee