When talking today about solid dosage form production, often containment immediately becomes one of the issues. Why? The first reason is that APIs are becoming more and more potent: meanwhile more than 50% of all NCE (New Chemical Entities) are classified potent (OEL < 10 μg/m³). Secondly, health and safety authorities all around the world are putting more focus on the protection of operators dealing with these substances. The third reason is that suppliers of various hardware components have developed a huge variety of containment solutions, making it difficult to decide which is best, even for experienced people.

Before we look at the factors defining the required containment levels, and discussing the possible hardware solutions, some fundamental thoughts about containment need to be covered first.

The design of a tableting line able to handle potent APIs in a safe way requires an in depth understanding of the required level of protection. Here the specifics of the API, the dilution with excipients, the containment performance of the equipment and the frequency of operation are the key parameters which are linked by complex interrelations.