SubscribeDisposable technologies are helping pharmaceutical manufacturers maintain high levels of sterility and meet mounting pressure to improve the speed, safety and economics of vaccine production.
Critical to effective single-use processing operations are aseptic connection devices. Pharmaceutical manufacturers typically make about 25,000 aseptic connections each year, with some large manufacturers making as many as 100,000 aseptic connections annually.
Pall Corporation (NYSE: PLL), the pioneer in providing single-use technologies to the biopharmaceutical industry, is expanding its line of Kleenpak™ Aseptic Connectors with two new sizes, 1/4- and 3/8-inch. The new sizes enable vaccine manufacturers to apply the safety and efficiency benefits of instant aseptic connections throughout more of their disposable operations to help speed time to market and comply with good manufacturing practices.
Pall revolutionized the aseptic connection process by shortening the time needed for connection from 15 minutes to seconds when it introduced its 1/2-inch Kleenpak Connector. The addition of the two new Kleenpak Connector sizes increases flexibility to implement aseptic connections in more applications to improve disposable processing efficiency. This is especially important to complex vaccine production, which often requires a greater number of connection steps.
"Advances in aseptic connection are making disposable processing a more viable and profitable option for vaccine manufacturers," says Helene Pora, Ph.D., Marketing Director, Pall Life Sciences. "Pall has championed single-use technologies and will continue to expand its product offering so that more manufacturers can reap the benefits of disposable processing in even more applications."
Vaccine manufacturing is particularly well-suited to single-use technologies. Vaccines are subject to some of the most rigorous quality and regulatory requirements because they are generally administered to large populations of healthy individuals.
By eliminating cleaning and cleaning validation as well as reducing the risk of cross-contamination, single-use technologies ensure sterility while also saving time and money. This is especially critical for campaign-based vaccine production and when rapid ramping up of manufacturing is needed in response to epidemic outbreaks.
The Kleenpak Connector is easy-to-use and projects an audible snap to signify that a sterile connection has been established. The Kleenpak Connector is rigorously tested to assure the integrity of connections, which is vital to sterile drug manufacture.
Pall Corporation is expanding its line of Kleenpak™ Aseptic Connectors by adding two new sizes, 1/4- and 3/8-inch to its 1/2- inch connector so that biopharmaceutical manufacturers can achieve the safety and efficiency benefits of instant aseptic connections throughout a much wider range of disposable operations.
East Hills, NY (March 19, 2007)