Single-Use Equipment Standardization: Possible Or Not?

By Maik W. Jornitz, Vice President, G-CON LLC

Since the introduction of single-use technologies into the biopharmaceutical processes in the early 1990s, a multitude of supplier companies mushroomed. The result is that these vendors market many unique single-use product designs, which makes it a chore for an end-user to choose and to find a second supply source. The debate is whether single-use systems can be standardized or not. It is an intense debate, as some end-users believe standardization restricts their process needs, and most vendors think that they would lose the competitive edge if they cannot customize their assemblies. On the other hand, end-user benefits would be the possibility of multi-vendor choices, lower inventories, and experience build-up. Vendors would benefit with the avoidance of frequent production set-up changes stock items, which create the possibility of just-in-time deliveries. Similarities to this situation can be found in the past, especially in the field of membrane filter cartridges. This paper will examine the lessons learned and apply these to the single-use scenario.