Single-use closed system failures

Cell and gene therapy biological therapies and vectors used to create them are designed to express a transgene, while therapeutic for an illness, may result in undesirable changes to the healthy worker, potentially for their lifetime.

Single-use closed systems are pre-dominantly used to prevent worker exposure and protect the product.  Closed systems failures (i.e. tubing failures, connection/attachment failures, collection vessel ruptures and tank overflows etc.) may impact product integrity and expose workers to spills, splash or aerosol release.

The BioPhorum EHS & Biosafety team wanted to better understand the industry approaches to evaluating containment of single use closed system failures resulting in spill, splash or aerosol release.

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