BioPharm International - November 2022

BioPharm International - November 2022

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6 BioPharm International ® Manufacturing and Facilities 2022 eBook Automation needed. In addition, it is likely that the technology or infrastructure needed is not in place for this automa- tion solution to be implemented, which can lead to even more work for the engineering and automation companies—and additional costs for the end-user. This rework and potential downtime for the machin- ery required while changes are made can also com- promise data and operational integrity. Thus, when a gap in technology or automation efficiency is noticed, it requires immediate attention. Bringing back the engineering company, original equipment manufacturers, sof tware vendors, and end-user stakeholders to consult on the project is not only greatly inefficient but costly. What if the project took a different approach? The selected engineering and automation companies should collaborate from the planning and design stages of a project all the way through to the commissioning and qualification phases. This approach results in a more efficient, re- liable, and modern design that is developed far faster than the traditional method. The right people in the room Some of the most successful companies in starting up or maintaining single-use facilities often share a com- mon first step—getting the right people in the room early. At the beginning of a project, it is crucial that a representative from the end-user define the vision for the facility in its entirety. From engineering to manufacturing startups, this vision will help outline expectations, requirements, and a strategy for future development. The vision may involve management of inventory in bag bins, active control of automated pinch valves, or preventative maintenance analytics, but it always requires multiple team members with different skills to realize this vision. The right rep- resentatives from an engineering, procurement, and construction (EPC) company and an automation sup- plier also need to be involved early to allow for better knowledge sharing between the parties to positively inf luence the facility's strategy and build the best solution for the end-user. Early discussions are used by an engineering team to translate the end-user's vision into a design basis that describes the f unctionality, device selection, map of the operational footprint, and how the pro- cess is being controlled. This effort usually requires a system integrator to be engaged who must work in parallel with the engineer to define control method- ologies, document system requirements, code, define testing plans, support installation efforts, interact with software vendors, and so on. When these steps are not performed in parallel, delays or rework are common results. In addition, multiple vendors are commonly involved with different unit operations in biotech facilities, which means navigating competing priorities. The sooner the collaboration can begin, the better chance that standardization is realized across the project. Standardization is especially vital to better support employees who work with and maintain the equipment and technology day in and day out. Stan- dardization is also important for facility-wide system integration between the equipment and higher-level manufacturing systems. Without it, data can be ren- dered unusable if it is incompatible with other infor- mation being collected or it cannot be synchronized to offer visibility and insights into full operations. Stron- ger and earlier collaboration leads to the adoption of standards and, in turn, more useful data. Keeping data integrity and extensibility in mind Even if the right people are in the room to begin the single-use facility project, tight deadlines and multi- ple stakeholders can make it hard to manage priorities and make sure the facility design will meet expecta- tions and pass the qualification process. As planning starts, there are two important considerations to keep in mind: data integrity and extensibility. Perhaps one of the most important facets of data integrity when collaborating with multiple vendors, complex equipment, and critical data is cybersecu- rity. Typically, the more data that are generated, the more security is needed. In the early stages of plan- ning, vendors may come in offering a new way to monitor reactors, but they might not consider that the camera they are suggesting would generate massive amounts of data that need to be stored efficiently and More on single-use systems Visit to read more on single-use technologies including the following: • Specialty Polymers Add Value to Single-use Technologies for Biopharmaceutical Processing specialty-polymers-add-value-to-single-use- technologies-for-biopharmaceutical-processing • Addressing the Training Gap for Single-Use Technologies view/addressing-the-training-gap-for -single-use-technologies • Large-Scale Single-Use Bioreactors Can Maximize Long-Term Scale Up scale-single-use-bioreactors-can-maximize- long-term-scale-up

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