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

31.03.2011
Kleenpak™ Sterile Disconnector maintains sterility on both sides of the disconnection

Kleenpak(TM) sterile disconnectors provide sterile disconnections in less than 30 seconds. (Photo: Business Wire)

Pall Corporation (NYSE: PLL) 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.

Pall Life Sciences provides cutting-edge products and services to meet the demanding needs of customers discovering, developing and producing biotech drugs, vaccines and classic pharmaceuticals. Pall technologies are also used to collect and process blood components and help protect patients from hospital-acquired infections. The company’s membranes and membrane devices optimize detection and sample preparation in the drug research, clinical diagnostics, genomics, and proteomics markets. Pall is a leading provider of separation systems and single-use filtration and purification technologies to pharmaceutical and biotechnology companies to support faster development of new drugs and vaccines that are safer and require less energy and water to produce.

About Pall Corporation
Pall Corporation (NYSE:PLL) is a filtration, separation and purification leader providing solutions to meet the critical fluid management needs of customers across the broad spectrum of life sciences and industry. Pall works with customers to advance health, safety and environmentally responsible technologies. The Company’s engineered products enable process and product innovation and minimize emissions and waste. Pall Corporation, with total revenues of $2.4 billion for fiscal 2010, is an S&P 500 company with more than 10,000 employees serving customers worldwide. To see how Pall is helping enable a greener, safer, more sustainable future, visit www.pall.com/green.
Contacts
Media Contact:
Rebecca Kale
Pall Life Sciences
Senior Manager, Marketing Communications
Telephone: +44 23 92 303 733
Email: rebecca_kale@europe.pall.com
Source: Pall Corporation

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