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Thursday, August 11, 2011

The Next Generation of Aseptic Processing Equipment

Although tacitly acknowledged for some time, only during the last few years have both industry experts and regulatory authorities fully acknowledged that humans working in cleanrooms are the chief source of microbial contamination. Because humans are the only significant source of contamination, it follows that they are also the greatest obstacles to the achievement of sterility assurance. It is logical, then, that contamination control technologies currently described as "advanced" focus on enhancing the control of human contamination.
The two technologies most often referred to as advanced at the present time are isolators and blow–fill–seal systems. These technologies represent two different strategies for contamination control. Isolators rely on what can be termed a separation strategy in which the human operator cannot access the aseptic work environment directly. Access to the isolated aseptic zone is achieved only through features that allow separated manipulation. Glove and sleeve assemblies and, in some cases, half-suits are used to provide indirect access with a substantially reduced potential for human contamination.
James E. Akers , Mamoru Kokubo , Yasusuke Oshima.
Pharmaceutical Technology, May 1, 2006.


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