Retrofitting stainless steel plants with single-use systems is driving a “paradigm shift” in drug production but creates logistical problems, an AAPS panel said.
Adding single-use components to existing stainless steel facilities creates hybrid production plants that offer some of the benefits of disposable systems. In particular, converting to a hybrid format can increase the lifespan of a plant by making it more adaptable to new requirements.
“If you don’t have an adaptable facility eventually it will be mothballed and sold off”, Kim Nelson, director of strategic consulting at CRB Consulting Engineers, told an audience at AAPS 2011.
Nelson said some existing plants will hit the “sweet spot” and be easy to convert, but others present more problems. In some cases the conversion challenges will make it inappropriate to add single-use components to the plant.
The flow of material, equipment and waste is changed by adoption of single-use systems and stainless steel plants may be ill-equipped for the new patterns. In particular, corridors and airlocks may be too narrow for transporting single-use components around the plant.
Plants using single-use equipment also need more robust floors and walls than stainless steel facilities may have, Nelson said. Incorporation of single-use components is also likely to add to warehouse requirements.
Small molecule applications
The potential for using single-use systems in production of biologics is “basically unlimited”, Eddie Hairr, Mobius single-use sales specialist at Millipore, said. Use of single-use systems in production of small molecules is more restricted but there are opportunities.
Most of these applications come in downstream processing. Processes that can benefit from single-use system include sterile sampling, sensors, mixing, and final fill and finish, Claire Scanlan, process development scientist at Millipore, said.
Benefits include cuts to changeover time, lower risk of contamination, and greater flexibility. Interest in single-use fill and finish systems, which come fully assembled and validated, is soaring, Scanlan said, particularly at plants that handle multiple products.