New Genderless Sterile Connection Technology - A Quality by Design Approach for Greater Sterility Assurance from Manufacturing to Use

One of the major trends in pharmaceutical manufacturing over the last decade has been the replacement of traditional, reusable cleanable components by single-use disposable alternatives. The increasing scope and availability of single-use technology has also presented the opportunity to design and assemble multi-component manifolds and systems that can offer benefits such as elimination of in-process cleaning and steam sterilization, faster processing times, more flexible manufacturing and lower risk of operator error. In this publication, we describe the approach to the design, development and validation of a new sterile connector, the Pall Kleenpak^® Presto Sterile Connector, with a unique design and manufacturing procedure that ensures the robustness and full traceability of every connector.