Single-use technologies will continue to be adopted over the next decade within the biopharmaceutical industry in an ever-expanding
capacity (4). Establishing controls and processes that follow an ICH Q10 risk-based approach is one suggested methodology
to help establish best practices and controls for introduction and security of these single-use technologies.
With the movement of the industry towards single-use components, many companies have started to address the impact of single-use
equipment on product quality. The use of risk analysis is a powerful tool for implementing a single-use program.
KEVIN D. LEAR is a Principal Engineer, NICOLE COLLIER is Engineer III, and KEITH BADER is Sr. Director of Technology, all at Hyde Engineering + Consulting, Inc, Boulder, CO.
1. BioSolve Software Modeling, BioPharm Services, Chesham, Buckingham, HP5 1DG, UK,
2. Intelligen Software Services, Intelligen, Scotch Plains, NJ 07076 USA,
3. ICH, Q10, Pharmaceutical Quality System (2008).
4. Single Use Bioreactors for Pharma; World Market 2012-2022, Vision Gain
5. Martin, J. BioPharm Inter., 23 (11)(2010).
6. ICH, Q9 Quality Risk management (2005).