In the last few years, the biotech industry has witnessed the rapid adoption of single-use technology in bioprocess manufacturing. Concurrently, there has been a strong push to reduce operating costs by moving manufacturing from traditional stainless steel equipment in a cleanroom to single-use disposable solutions in a “gray space” environment. As contamination risk increases exponentially in gray space environments, it has become imperative to ensure a validated sterile flow path for single-use solutions.
Presterilized single-use connectors perform the critical function of connecting two presterilized single-use components in a nonsterile environment, while maintaining fluid-path sterility. As a result of the increasing use of single-use connectors, many new types of connectors have entered the marketplace. At the same time, their use has expanded beyond the typical upstream buffer and media applications, into high value-added downstream applications like ultrafiltration/dialfiltration and final fill and finish. This makes it extremely important that the choice of a single-use connector should take into consideration robustness of the connector design and sterility claims made by the vendor.
By design, a sterile connector should protect the fluid path by never exposing it to the open environment. For example, Millipore’s Lynx® S2S connector employs a solid plug, not a membrane or peel strip, that could create a gap.
When making sure that a single-use connector maintains a sterile fluid path, it is important to verify that the methods used to support these claims are valid, reproducible, and provide meaningful results. It is equally critical to ascertain that the selected connector will secure the fluid path at a sterility assurance level (SAL) of 10-6 under the most rigorous conditions.