Operational Excellence in Immunoassay Manufacturing II

Spain - January 26, 2021

How Biokit is encouraging Operational Excellence in immunoassay operations

The manufacturing process of an immunoassay, which ranges from the manufacturing of the IVD biomaterial to the filling and packaging activities, is a complex and at times challenging process. We provide our partners with more than 300 different immunoassay and IVD Biomaterial references that are manufactured with different manufacturing processes.

Biokit, in line with the Werfen Group philosophy, is always looking to create an environment of continuous improvement for its employees and external collaborators.   

Re-thinking processes: looking for ways to do things differently  

Our Approach

One of the operational excellence projects involved a key immunoassay portfolio that we manufacture for one of our partners. A transversal team with members from each of the departments working in the supply chain conducted a deep review of the different flows involved in the manufacturing, filling and packaging processes, in order to detect opportunities for improvement.  The manufacturing process has been optimized by avoiding making extra batches for raw material selection. This optimization was made possible thanks to the statistically significant data obtained after analyzing the whole manufacturing process.

In the filling and packaging processes, the flow has been optimized by requesting packaging material in advance. This optimization has also contributed to reduce the waiting time in this step of the manufacturing process.  

Operational Excellence in IVD Immunoassay Development


As a result of this operational excellence project, the different control tools implemented in the flows of the manufacturing, filling and packaging processes have allowed us to evaluate robustness and sustainability. It also enabled us to identify slight degrees of variability within the process and to find new opportunities for improvement.

One of the results obtained was in the filling and packaging process, in which, by implementing new measures for obtaining material with variable data,  the global packaging time was reduced by 50%.  

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