In the new Annex 1, the batch size

In the new Annex 1, the batch size requirement is unchanged. The typical number of units to be filled is a minimum of 5000 to 10,000 units. For batch sizes that are smaller than 5000 units, the number of containers filled should be at least equal to the production batch size and should be sufficient to simulate all the activities and interventions in the aseptic filling process.