Online Tools

PRODUCT SPECIFIER Determine coupling types for use in your particular project
CAD Downloads Download CAD drawings of specific couplings to use directly in your design software
Product Catalogs Use of our product catalogs to view our complete product list
Product Catalogs
Overview Adapting Facilities Sterile TFF Loop
left left left

Sterility Assurance: Creating a Completely Sterile TFF Loop

STC1700000 on Bioreactor

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.

Previous Page
Back to Top