Securing and Qualifying Single-Use Technologies - The authors suggest techniques for mitigating risk and securing the supply chain for single-use components used in biopharmaceutical manufacturing. -

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Securing and Qualifying Single-Use Technologies
The authors suggest techniques for mitigating risk and securing the supply chain for single-use components used in biopharmaceutical manufacturing.


BioPharm International Supplements
Volume 26, Issue 4, pp. s18-s23

CONCLUSION

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.

REFERENCES

1. BioSolve Software Modeling, BioPharm Services, Chesham, Buckingham, HP5 1DG, UK, http://www.biopharmservices.com/.

2. Intelligen Software Services, Intelligen, Scotch Plains, NJ 07076 USA, http://www.intelligen.com/.

3. ICH, Q10, Pharmaceutical Quality System (2008).

4. Single Use Bioreactors for Pharma; World Market 2012-2022, Vision Gain http://www.visiongain.com/.

5. Martin, J. BioPharm Inter., 23 (11)(2010).

6. ICH, Q9 Quality Risk management (2005).


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