Sterility Assurance: Creating a Completely Sterile TFF Loop
A major biopharmaceutical manufacturer selected Steam-Thru Connections as part of their down-stream tangential flow filtration (TFF) system out of concern for maintaining process sterility. Their specific technology consists of two-layer microspheres composed of biopolymers that are about the same size as red blood cells. This size creates a serious problem for downstream processing; unlike therapeutic proteins, once the bioSpheres are assembled, they cannot undergo any sterile filtration steps at 0.1 to 0.2 μm. This required the downstream engineers to design a sterilely robust process system.
One critical purification step is microfiltration TFF. To meet their sterile assurance requirements, the manufacturer developed a sterile TFF loop consisting of both reusable stainless steel and single-use components. “Using Steam-Thru, we can connect our single-use waste collection bag in advance and sterilize the connection point when we SIP our stainless steel retentive vessel. After actuating the Steam-Thru valve, we’ve created a completely sterile TFF loop with both reusable and single-use components.”
Ease-of-use and storage issues are other benefits of the system. “Steam-Thru Connections are light-weight compared with steamable valve assemblies. Our 200 L single-use bag system with the Steam-Thru doesn’t require much storage space allowing us to keep 1000 L or more of waste collection capacity on a couple of shelves. Cleaning one vessel instead of two for our TFF is also a big plus.”
Integrating single-use systems into the microfiltration TFF process can help manufacturers streamline process steps, reduce cleaning and validation while providing the assurance of a completely sterile Tff loop.