Disposable aseptic connectors (DACs) are becoming standard connection tools for single-use bioprocess manufacturing. DACs enable single-use processing equipment and unit operations to be safely and quickly connected while minimizing or even eliminating the need for classified manufacturing space. Currently, there are no regulatory standards which define the level to which DACs must maintain sterility in non-sterile environments. Therefore, manufacturers are expected to provide regulatory support material to end users. This poster explains recent work performed by GE Healthcare Life Sciences to expand the material available for ReadyMate disposable aseptic connectors. An aerosolized microbial challenge was used to verify the ability of ReadyMate connectors to maintain sterility under extreme conditions. Transfers of culture medium were performed after each connection and the transferred medium was incubated to verify sterility. Positive and negative controls were included in the study. A 100% success rate was achieved.

Aerosolized bacterial challenge of disposable aseptic connectors used in bioprocessing applications

243rd National Meeting (2012)

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