The author provides a review of the concepts of design and qualification that apply to single-use systems.
BioPharm International eBooksVolume 28, Issue 14 Single-use technologies including polymer film bags, tubing, filter capsules, and appropriate connectors have become widely accepted in bioprocessing of proteins and vaccines.
New publications from BPSA and PDA highlight best practices for particulate control, quality agreements, and implementation strategies.
Progress is being made in the development of harmonized best practices for single-use systems.