Introduction
Biopharmaceutical manufacturers routinely depend on closed aseptic systems to ensure the sterility of the therapeutics they produce. To build closed aseptic bioprocesses, biomanufacturers and process engineers must routinely join individual tubes, forming sterile connections using either single-use connectors or tube welders.
Single-use technologies (SUTs), like single-use sterile connectors, have long played a vital role in the closed processes found in biopharmaceutical product manufacturing. Single-use technologies offer several well-documented benefits for commercial operations, including reduced manufacturing costs, time and labor savings, the elimination of batch cross-contamination risks, and more. Even with single-use connector advantages, biomanufacturers also use sterile tube welding systems for creating a closed aseptic system using smaller diameter tubing (<3.2mm or <1/8”).
As precision medicine gains greater momentum and new candidates enter clinical trials, the demand for smaller batch aseptic manufacturing will grow further. This is especially true for new modalities such as cell and gene therapies and other small-batch biotherapeutics, including those needed for clinical research. However, until recently, small-volume sterile single-use connectors have not been commercially available. This means that sterile tube welding has been the industry’s only solution for building closed aseptic systems with small-diameter tubes. As a result, biologic, cell, and gene therapy manufacturers have assumed the costs and risks associated with tube welders.