In May 2022, a customer embarked on plans to optimize their operations, implementing a closed expansion process. The aim of the closed expansion protocol was to enable the simultaneous expansion of multiple products within a single facility, eliminating concerns about cross-contamination through airborne particles. The new process introduced the risk of inadvertent contamination when similar flasks containing different products were present in the same room.
To address this issue, the scientists devised a spreadsheet-based batch record system. This solution not only managed the expansion process but also ensured proper segregation of products. However, it fell short of compliance standards.
The closed expansion process was scheduled to be implemented for production in 2023, necessitating a compliant and robust flask management process.
This customer joined forces with SciCord to transform their existing spreadsheets into a production-grade batch record system. This transformation involved the development of several modules to digitize all aspects of the process:
To initiate the batch record development process, the engineers provided SciCord developers with one or more workbooks. The workbooks lay out the process steps and defined the flow of materials and required calculations. The workbooks form the basis of the module and are integrated with LIMS. In a matter of days, the first iteration of a process is implemented (plug and play) in a test environment for review by the engineers. Typically, 2-4 iterations of each module are required to finalize the process. Each module can be developed and ready for documentation and testing in just a few weeks.
“Enhancements/upgrades and testing performed quickly”
Care to learn more about why the SciCord Informatics Platform leverages the spreadsheet paradigm? Learn more here!