ABSTRACT

Disposable components came into use first in the field of connectors and lines, as it was difficult to clean them. Media storage systems arrive at the bioprocess facility sterilized by gamma irradiation and often are fitted with integrated filters, sampling systems, and connectors. Flexible tubing with aseptic connectors is used as transfer lines between each reactor in the process. The aseptic connectors once installed cannot be disconnected to maintain patency of the process. Pumps are used for fluid transfer by creating hydrostatic pressure or by differential pressure; the maximum allowed pressure would be determined by the weakest part of the bioprocess component exposed to the pressure. One of the most commonly used method is to connect the tubes or components using sterile connectors under a laminar flow hood. Critical to effective disposable processing operations are aseptic connection devices. The most convenient connectors are aseptic connectors that allow aseptic connections in an open uncontrolled environment without using a laminar flow hood.