The biopharmaceutical industry’s movement away from large-scale, fixed-tank facilities to flexible facilities featuring single-use technologies (SUTs) has demonstrated the value of modular equipment and agile process design. SUTs have proven to be clear advantages to end users because those technologies enable quick facility build and changeover times. But linking SUT equipment with equally flexible automative technology has been difficult. Herein a group of automation experts from the BioPhorum Operations Group (BPOG) elaborate “plug-and-play” principles and introduce a supervisory control system that can standardize bioprocess communication protocols and reduce equipment startup or process changeover validation time (GMPs).
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The writers thank the following reviewers for their careful consideration of this manuscript: Michel Claes (Siemens), Burkhard Joksch (Sartorius Stedim), Bruce Kane (Rockwell Automation), Uwe Kritzler (F. Hoffmann-La Roche), and Robin Payne (BioPhorum).
Chun Lai is an automation engineer at Merck. Steven Miller is director of software and automation at Millipore Sigma. Keith Morris is automation subject matter expert at the PM Group. Pietro Perrone is an automation process engineer at GE Healthcare. Rene Reinbigler is enterprise architect in the software and automation division of Millipore Sigma. And Gene Tung is executive director of manufacturing information technology at Merck. Please direct inquiries to Robin Payne of BioPhorum Operations Group, The Gridiron Building, 1 Pancras Square, London, N1C 4AG, firstname.lastname@example.org.
The life science business of Merck KGaA, Darmstadt, Germany operates as MilliporeSigma in the United States and Canada.