Qualifying Single-Use Components with a Design Space

Manufacturers implementing single-use components often face challenges brought about by three factors: (1)every introduction of a single-use component is treated as unique, therefore, implementation becomes cumbersome since qualification and implementation activities are performed at the same level of thoroughness every single time; (2) regulatory filings specify the manufacturer and model of many of the single-use components, complicating single-use lifecycle management within GMP and quality management systems; and (3) the industry lacks the needed motivation to drive standardization in terms of design, material of construction and supplier qualification.