SAMSYS. Sustainable Automation Management System ELECOMP Capstone Design Project

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1 Sponsoring Company: SAMSYS Sustainable Automation Management System ELECOMP Capstone Design Project Amgen Inc. 40 Technology Way, West Greenwich, RI Phone: (401) Background: The treatment of millions of seriously ill patients worldwide depends on the safe and reliable production of biologic medicines, which are administered by injection or intravenously. A worldwide leader in biologics manufacturing, Amgen has an outstanding track record of reliably delivering high-quality medicines to patients who need them. Significant skill, experience, vigilance and commitment are critical to help ensure the quality of a biologic medicine each time a new batch is made. At Amgen, robust quality control and a reliable supply of medicines for patients are every bit as important as scientific innovation. (amgen.com) Technical Director: Stan Youngsaye, Principal Engineer (URI Class of 2001) youngss@amgen.com Page 1 of 6

2 Associate Technical Directors: Justin Luongo (URI Class of 2005) Senior Automation Engineer Jeff Pouliot Senior Process Engineer Project Motivation: The automation of Amgen s manufacturing process is controlled by advanced software that breaks down systems (Operational Units) and the recipes for different products into commands and parameters. When Amgen would like to produce a new product in their facility, automation code and associated requirements documentation must be written. Errors in this process, some as small as a single parameter, can result in the loss of raw materials or even damage to machinery; costing upwards of millions of dollars. The motivation for this project is derived from the automation process. With single steps in a recipe having tens of thousands of associated parameters, code reuse is a key component to accelerating the process. Without a system capable of comparing existing code and documentation, each inclusion of a new product has to "start from scratch". This decreases productivity, and increases the likelihood of inaccuracies in the process. Further, any modification to an operational unit or recipe may affect one another and related documentation as data dependency is an issue. Page 2 of 6

3 The proposed ELECOMP Capstone Design Project is the development of a sustainable database-driven, automation management system that holds all of the software parameters and divides them into what operation they are used for (called a Unit Operation), which products, or recipes, they are used to make, or which system operation (called a phase) they are used in. The engineers will be able to view, compare, and modify code and parameters stored on a customized database through use of a GUI interface. The system will also implement version control, and be able to create and modify technical documents. Anticipated Best Outcome: The best outcome for the proposed project is a sustainable database-driven, automation management system. The system backend will be supported by either SQL or a comparable relational database variant, and have an easy-to-use front end user interface. Using this system, engineers will be able to search a database of all unit operations, recipes, steps, phases, and even specific parameters. Users will be able to modify or change these objects; adding changing parameters or larger systems. When changes are made to this system, any and all data dependencies are located and either resolved automatically or with the user s approval. Users will also be able to compare recipes and their components and see similarities between them and both new and existing recipes. Sourcing from these, users will be able to create new recipes; with additional parameters being synchronized among the others. Once completed, the application will automatically generate both Unit Operation and Recipe Requirements Documentation per any necessary specifications. This will span from the application and will also include a robust version control system to allow engineers the ability to track changes being made. Page 3 of 6

4 Project Details: Software Engineering: Design a database structure for Amgen s existing data; including Enhanced-Entity Relation Diagrams and, if necessary, equivalent relational algebra. Define a clear list of necessary queries (optimized where possible), user access levels (if needed), and overall functions for the database with relation to the application. Design and implement a system to ensure data validity across recipes for affected operational units. Design and implement a version control system able to track modifications, compare previous versions, and restore from earlier dates. Design and implement a system capable of generating Unit Operation Requirements Documents (OURD) and Recipe Requirements Documents (RRD) automatically. In the case of changes to dependent data, regenerate existing RDs. Design and implement a simple user interface to enable to user to perform all necessary application functions. With the aforementioned tasks, a phase-based approach has been proposed: Phase 1 : Design and implement a system capable of supporting basic searching and filtering functions Phase 2: Expand on the existing system to include insertion of new data, updates to existing, and a comparison system that detects similarities from different recipes. Phase 3: Design and implement a document management system capable of viewing, creating, and modifying both operational unit requirement documents and recipe requirement documents. Implement a version control system. Phase 4: Implement the system in the Amgen environment. Consider sustainability, security, data-locking, connectivity, etc. (Note: All work will be done at the Amgen site located at 40 Technology Way, West Greenwich, RI Students must have a means of transportation to and from the facility. ) Page 4 of 6

5 Conceptual Block Diagram Composition of Team: Two computer engineers will be assigned to the project. Student Skills Needed : Technical - Required Proficiency and experience in at least one object-oriented language (OOS) Experience in database design, normalization, and database-driven applications Technical - Preferred Chemical engineering knowledge (bio-manufacturing and associated procedures) GMP experience Personal - Required Willingness to learn new skills. Adaptability with existing knowledge in computer engineering A drive to exceed expectations and provide only the best quality of work Both a team player and independent developer; understanding individual effort as part of a collective Must have a means of transportation to get to the Amgen site. Page 5 of 6

6 Anticipated Best Outcome s Impact on Company s Business: Having a tool capable of cataloguing and comparing data as well as generating Requirement Documents would increase overall speed, accuracy, and efficiency of the automation process. This would enable Amgen to introduce more products into their West Greenwich facility and decrease total cost. Broader Implications of the Best Outcome on the Company s Industry : The inclusion of a management utility in the field of bio-manufacturing automation would allow for more products to be produced with greater accuracy. The associated reduction in overhead costs could lead to an overall reduction in pharmaceutical price and increase availability. Other Pictures and Technology Relevant to the Project: Delta V Automation Systems: Developing the Perfect Plant: A high tech approach to supporting low cost bioprocessing plants - Robert Gamber Principal Engineer - March 27, 2014: Page 6 of 6