There are many nuances that require a more focused approach to risk identification and project management for the “new” manufacturing facilities implementing Single-use Systems (SUS). One of the challenges that Project Managers will face is having to get outside of the familiarity of the traditional project management box to address many of these issues unique to the new facility models being developed around the enabling technologies of SUS.
Many companies embarking on the implementation of SUS have little to no previous experience from which to expand on. As new processes are moving through clinical development based on single-use technology, the list of unknowns grows and the need to clarify assumptions increases. While the process still “drives the train” for SUS-based facilities just as it does for traditional stainless steel-based systems, the issues become different. Product characteristics have a greater impact on materials-of-construction and product contact surfaces. Synergy between different vendor platforms and control of the supply chain are more difficult. The compatibility of materials and components, the systems for quality testing of components, and the overall procurement philosophy around supplier qualification are key issues of risk.
Closure definition and analysis are a critical aspect of system design. Process closure analysis is more detailed and clearly a focus of regulatory scrutiny. Managing the logistics of the numerous tube sets introduces many aspects of “spaghetti management” that will require a different level of project management and engineering in order to bring value and efficiency, not to mention compliance with many EH&S and cGMP regulations. The focus must be on operational efficiency.
Operator interface and access is also critical. Bag movement and placement, tube set interconnection and closure verification, and waste removal and management introduce new design attributes for the project.
Flexibility definitions will vary from company to company and project to project. Project delivery will be highly integrated with the design approach as new modular facility approaches and platforms are introduced. Variability, redundancy, and utilization are integrated to provide the best solution to meet business goals and project needs.
At Interphex 2015, the subject matter experts, project managers, and engineers at IPS will again be organizing technology tours to assist you with where to start your project and how best to manage the many nuances just mentioned. They will provide introductions to the many of the new enabling technologies in bioprocessing that are shaping future manufacturing facility design attributes.
