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.
I don't have access to this document
Make a selection below and submit your request. We will get back to you ASAP.
My company would like to become a member
If you're not sure if your company is a member of this Phorum, or if you would like to enquire on behalf of your company about becoming a member, please see our membership page.