Standardization Times in a Blending (Flex 2 Unit Operation) Manufacturing Process

Abstract

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.