Pall Introduces First Sterile Disconnection Device for Use with Bioprocessing Containers during the Manufacture of Biologicals

Pall Corporation is launching an innovative solution for convenient and secure sterile separation of flexible tubing assemblies. The single-use Pall Kleenpak Sterile Disconnector facilitates secure fluid transfer, preserves product integrity, improves operator safety, and reduces product waste at all process stages of biopharmaceutical manufacturing.

The Kleenpak Sterile Disconnector is the first device designed to maintain sterile integrity, even in cramped and uncontrolled environments, before and after separation of tubing. Its patented locking mechanism eliminates the risks associated with clamping and cutting, and requires no tools, calibration or maintenance. Disconnection is performed in less than 30 seconds, and sterility of the separate fluid paths is maintained throughout. Flow paths cannot be reopened or reconnected following disconnection, thus further securing product integrity.

The product strengthens the company’s Allegro™ single-use technology platform which provides processing solutions, technical support, and validation for single-use systems. Allegro systems offer consistent materials of construction and a flexible-solutions approach that speed and simplify qualification and validation requirements, and ease implementation.

“The Kleenpak Sterile Disconnector complements Pall’s Kleenpak Connector technology, the industry standard, as part of our Total Fluid ManagementSM solution for biopharmaceutical manufacturers. It gives our customers a reliable method of securing fluid transfer across the full range of sterile process interactions,” said Ken Frank, president of Pall’s Biopharmaceutical Division.

The Kleenpak Sterile Disconnector provides sterility and bioburden management around a range of applications including media preparation, product transfer between bioreactors, buffer preparation, waste removal, and holding of product intermediates or bulk product. It is fully validated and 100% leak-tested, and can be used in single-use or hybrid (linked to stainless steel hardware) systems. It can withstand autoclaving up to 130 °C or gamma irradiation up to 50 kGy.