Standardisation within Single Use Systems An Inevitability, But Does It Have To Be Painful?

A dominating focus of today’s single use systems in biomanufacturing  is the road towards standardisation between equipment suppliers. The absence of standardisation between single use system suppliers is seen as a key discourager to end users despite the many advantages the format provides to the pharma and biotech production process. Advantages to single use system standardisation include the avoidance of costs for system modification and faster implementation. (2)


In regards to the initial shift towards the standardisation objective, in a previous Pharma IQ Jerold Martin, Sr. Vice President, Global Scientific Affairs for Pall Life Sciences, noted: “When single use was initially introduced process design engineers were very enthusiastic about the fact that there was so many options, so many flexibilities. People could design the connections on bags and transfer manifolds, or things like that, in any number of ways, and they liked that, but as single use is maturing, a lot of facilities are concerned about the number of different stock keeping units and part numbers of single use that they have, and so they are seeking to internally standardise what configurations they are going to use to reduce the number of different variants that they’d have to source and inventory. But that’s consolidation. That’s a type of standardisation where you simply decide, I’m going to use transfer manifolds of different links, and things like that that you want to reduce that variation because it’s simpler to manage…”