Standardization Times in a Blending (Flex 2 Unit Operation) Manufacturing Process
Acevedo Colón, Gabriel
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The continuous evolution in standardization, digitalization, and changes in the ways of working in manufacturing in the pharmaceutical industry and the increase in production for product X by 2023, has made it necessary to study the work process and standardize the blending production unit of the Flex 2 production area. The Flex 2 area is dedicated to a single product only. For the preparation of the drug, the area of Flex 2 performs 2 different types of API mixing, since the drug in its final stage of compression is a Bi-layer tablet. The blending process requires standardizing the number of operators needed to execute the batches and the number of batches that can be manufactured in the Flex 2 Blending unit. In 2022, a total of 610 batches were processed and the average batch cycle time was 7.0hrs. Key Terms - Blending, Cycle Time, Lean Manufacturing, Standardization Times.