INTEGRATION OF PROCESS AND FACILITY
Figure 4: Systems integration architecture.
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Systems integration is one of the key elements in the start-up and on-going development of any facility. The future integration
of process analytical technology, electronic batch records, and electronic inventory control are all features that should
be iterative and not retrospective in any design. The autonomous clean-rooms are already equipped with all of the computing
power and I/O structure necessary to interface into process integration and manufacturing execution (MES) solutions, such
as Rockwell Automation's Factory Talk and PharmaSuite applications. The systems are built on modules of prevalidated software
and are configurable to the multiple disciplines and needs of the bioprocess industry. An example of this type of systems
architecture is highlighted in Figure 4.
CONCLUSION
Flexible environments and flexible single-use systems have eliminated many of the classical constraints on biopharmaceutical
processes and have allowed designers the ability to design modular bioprocesses and easily house them in properly classified
environments. The ability to repurpose, improve, change, and re-use these core elements of a facility, affects the industry
from large pharmaceutical to small biotech companies. Whether planning new facilities, establishing first time manufacturing
capabilities, or executing new supply chain strategies by decentralizing manufacturing, companies now have new options to
consider. And as suppliers continue to develop innovative products and collaborate effectively, the closer the biopharmaceutical
industry will get to achieving its future manufacturing strategies.
R. BARRY HOLTZ, PHD, is president of G-Con Manufacturing, College Station, TX, bholtz@gconbio.com
, and DENNIS POWERS is director of integrated solutions, North America, Sartorius Stedim North America, dennis.powers@sartorius-stedim.com
.
REFERENCES
1. K. L. Nelson, "Single-Use Technologies and Facilities," supplement to BioPharm Intl .
24 (11), s22–s28 (2011).
2. E. Greb and A. Drakulich, Pharm. Technol. 36 (3), 46–50 (2012).
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