Author Archives: Bio-Process Systems Alliance (BPSA)

Recommended Practices for Assuring Integrity of Single-Use Systems

The increasing uptake of single-use technologies (SUTs) in critical current good manufacturing practice (CGMP) processes and applications has made their integrity a critical quality attribute (CQA) for both suppliers and end users of such systems. Current regulations focus on final packaging, however, without taking into account the unique aspects of assemblies used in bioproduction. Ongoing initiatives include revision of PDA TR 27 (1) and creation of A STM workstreams (2, 3) to propose good practices for the integrity of single-use…