Interview
Pioneering the Development of a World's First Filter from Scratch
An Unexpected Opportunity to Join a Cutting-Edge Project
I joined the company as a new graduate with a major in organic synthetic chemistry, hoping to be involved in process development. However, an unexpected turning point came in my second year when I joined a novel filter project aiming to address the issue of nitrosoamine contamination, known as a global topic in the pharmaceutical industry. Initially, I was involved in the project simply because the team needed more members, and to be honest, I had limited awareness of the nitrosoamine issue at that time. But as I learned more about it, I became increasingly drawn to its complexity and significant social impact, and finally, I voluntarily asked to join the team. I was more than happy to join the team as I never imagined I would have the chance to work on such a cutting-edge project before.
A World's First, Unprecedented Initiative
I was tasked with selecting the packing material and determining the structure of the filter to remove atmospheric nitrogen oxides (NOx) at the parts-per-billion (ppb) levels—a contributing factor that increases nitrosoamine contamination. Removing NOx at the ppb level from the air was a world's first, unprecedented initiative, and we were literally starting from scratch with no clear path forward. The most challenging part of this initiative was setting up the experimental system. However, based on our deep discussion and repeated trial and error in small scale experiments, we successfully developed a novel filter system that maximized the functionality and cost-effectiveness, as well as verification of small-scale approaches in actual production equipment.
Applying NOx Removal System to Actual Production
I felt a great sense of accomplishment when our research findings were immediately applied to actual production equipment, enabling us to successfully remove NOx and produce formulations with low nitrosoamine content. At the same time, it was necessary to ensure that we should be on the same page with on-site staff in order to install the filter on the actual production machine. The production staff, in particular, raised concerns such as, “We don't want to introduce anything uncertain into the process,” and “What if production volume drops?” In response, I demonstrated that the filter was safe and it would have no adverse effects on facilities, and worked hard to gain the team’s support for this unprecedented trial to introduce the NOx removal filter into the air conditioning line for production machines.
Aiming to Become an Expert on the Nitrosoamine Issue
The nitrosoamine issue can arise at any point across the entire supply chain from active pharmaceutical ingredient (API) synthesis and the formulation processes to packaging materials process. In the future, I hope to become an expert on the broader nitrosoamine issues by collaborating globally with well-experienced colleagues in this field. My ultimate goal is to resolve the nitrosoamine issues in all our pharmaceutical products by making use of my experiences in this initiative.
(Interviewed in June 2025)
Interview
