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Ask The Expert - How concerned are you about leachables/extractables in single use connectors and tubing? Do you have plans in these areas?

Published: February 10, 2016
Sponsored By: GE Healthcare Life Sciences
Session Expert: Susan Burke, GE Healthcare



How concerned are you about leachables/extractables in single use connectors and tubing? Do you have plans in these areas?

One should be concerned about extractables and leachables coming from all components of a single-use assembly. As such, we have extractables data on connectors, tubing and all other components. This information can be found at the following website: www.gelifescisences.com/rsf. However, one should also evaluate the potential impacts of extractables and leachables by using a risk based approach that takes into account the interactions between process, fluid stream, and the single-use assembly. Such an assessment often leads to a reduced emphasis on smaller components such as connectors, and a greater focus on the major components, such as film.

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