The missing link between DOWN.STREAM and FILL & FINISH.
A meaningful process with a single use bag in its center.
We think this process deserves a name, we call it
It is the interface between the different process steps, starting with Integrity test of the bag, filling, protecting the bag, freezing, storing, shipping and finally thawing and draining. The process needs to be properly engineered and validated to guarantee robust and error free procedures.
The BULK DRUG SUBSTANCE gets tracked at all stages of this process flow.
Temperature, geo-location and schock are well known variables.