This 4TE story is about how we helped a company finding a root-cause in a Filter Clogging. Would you like to know more? Keep reading!

Imagine that your company is producing a Monoclonal Antibody (mAB) but, for some reason, the production is facing a delay. 

You have already tried many ways to find the root-cause of the problem but, unfortunately, without success. And, because of that, the quality and the revenue of your products started to become compromised. 

Let’s know what happened there! 

Our story’s main character faced a problem during the production of a mAB, due to a delay caused by a filter clogging at DP filtration.  

Despite the many attempts to find out what was causing it, they could not discover the reason for the problem. So, they decided to get specialized assistance. 

How did we help them in finding the Root-Cause in a Filter Clogging? 

As the quality of the product and the revenue had become compromised, it was essential to act quickly! Our intervention started with a thorough process analysis: 

  • Starting by analysing the process data from both Upstream and Downstream Processes (USP + DSP) for three different sites, using quality data information. 
  • Investigating the process history spanning several years of production. 

To make this analysis even more complete, we used a Multivariate Data Analysis to check any compounded effects. 

By following these tactics, we could identify the root that was causing the company’s problem. The filter was clogged due to a combination of factors from both USP and DSP. 

How did the company benefit from our intervention? 

Our solution started to define metabolites intake rates and addressed the quality issues and procedures. Also, more than identifying the root-cause, we deployed solutions to every production site, assuring that the production was resumed without further issues and ensuring improved consistent market supply. 

Our intervention was crucial for the company’s success since all future troubleshooting activities became easier and more streamlined.  

Our experience in Finding Root-Causes in processes. 

If your processes are not yielding what you are expecting or if you have tried already different ways to solve it and the problem remains, we’ve got the best solution for you. 

Look at our Root-Cause Analysis and Corrective and Preventive Action Services. Feel free to tell us about any challenges you may have; we’ll do our best to help! 

Related Topics 

If you’d like to know more about how we find the root-cause in processes, we have some blog posts that can satisfy your curiosity. Just click here and enjoy your reading!