Single-Use Transfer Lines: Suite-To-Suite Transfer
Traditional bioprocessing facilities transfer medium from the production suite to a preparation suite by using stainless steel manifolds with piping or reusable hoses as transfer lines. Advances in single-use technology allow bioprocess engineers to replace most storage vessels and fixed piping networks with single-use storage systems and tubing assemblies. Single-use eliminates the need for CIP validation for many components and reduces maintenance and capital expense by eliminating expensive vessels, valves, and sanitary piping assemblies.
Process engineers now incorporate single-use transfer lines between the bioreactor in the process suite and the transfer vessel. Using presterilized connectors and tubing, the medium can be moved from the production suite to the preparation suite without the need to sterilize stainless steel piping or equipment. The enhanced mobility eliminates many of the restrictions that hard-plumbed piping can place on the manufacturing facility and allows the manufacturer greater flexibility when determining which process to run in each production suite.
The risk of cross contamination in the suite-to-suite transfer process is high, especially in multiproduct facilities, and can potentially lead to product loss or reduced production yields. Pre Sterilized, single-use assemblies reduce these risks and improve the speed and safety of drug development and delivery.
In this example, pre sterilized tubing and connectors are used as transfer lines between the bioreactor in the process suite and the transfer vessel. A Steam-Thru Connector is used as an SIP connection on the outline line from the transfer vessel. An HFC39 quick disconnect coupling makes a sterile connection to transfer the media through the wall into the filling equipment line.