There are now five sterile connectors that have been widely used in bioprocessing. They are designed to make processing easier and reduce potential for products to become contaminated. So how does a biopharmaceutical manufacturer select one over the other? A few of them have been on the market now for several years. However, others are starting to penetrate the market and they come with various advantages to suit particular applications. This paper summarizes a typical review of features and testing available for selection, along with items to consider for best design and performance, particularly for a single-use system.
A critical step, and risk, in the application of single-use components, is their final connection to form a usable assembly. Sterile connection is the critical "communication," or bridge, by which all the other pieces are made truly functional. Sterile connectors allow two lines of tubing to be joined while maintaining a sterile fluid pathway. Each line of tubing is pre-affixed to a connector end that has a removable membrane or valve barrier for mating to another connector end. Thus, the process line is maintained as closed and sterile even before a connection is made. Sterile connectors are designed to connect one processing stream to another, such as a container to a sampling line, media to a product vessel, or a filtration assembly to a filling line. They become beneficial when no biocontainment hood is available to make an aseptic connection or when operators are pressed for time.
The line at the junction of the connection cannot be disconnected without force because of safety mechanisms in place to prevent this. If a disconnection is needed, one is best made using a disconnection device, tube sealer, or tube crimper. Theoretically, these single-use components can be used in a noncontrolled area and still maintain a sterile system.
On the Market
Sterile connectors currently on the market include the Kleenpak Sterile Connector (KPC) by Pall Life Sciences, Lynx S2S by Millipore, Opta SFT-1 by Sartorius Stedim Biotech, ReadyMate DAC by GE, and the Pure-Fit SC by Saint Gobain (Figure 1).
Figure 1. Sterile connectors (left to right): Kleenpak KPC by Pall, Lynx S2S by Millipore, Opta SFT-1 by Sartorius Stedim Biotech, ReadyMate DAC by GE, and the Pure-Fit SC by Saint-Gobain.
There are other types of similar devices that provide slightly different outcomes or are used for different purposes. Though not discussed in this paper, they include, steam-through connectors, non-sterile connectors (quick-connects), and tube welders.