Hi Gareth! Could you explain what were the primary considerations and approaches Univercells Technologies took when designing, expanding, and maintaining its cleanroom facilities?

When setting up a cleanroom, key considerations include aligning cleanliness levels with international standards and EU GMP grades. At Univercells Technologies, we targeted an ISO-8 classification to meet appropriate conditions for our scale-X™ bioreactor range and Single Use Technology.

Regarding space, we adopted a modular approach, doubling our cleanroom capacity from 2019 to 2022 to accommodate increased product volumes and complexity. This expansion utilized existing infrastructure, allowing flexibility and cost-effectiveness without disrupting operations.

Choosing an engineering partner also involves weighing factors like cost-effectiveness versus regulatory expertise. Smaller local firms may offer cost benefits but could face challenges with regulatory compliance compared to larger international groups.

Finally, maintaining operating parameters within the targeted classification involves a balanced approach in gowning, cleaning practices, and HVAC optimization. At Univercells Technologies, we prioritize meeting required standards without unnecessary costs.

Considering the emphasis on cleanroom expansion and operational efficiency, how does Univercells Technologies’ approach to cleanroom management directly influence the reliability of our supply chain and the availability of products for customers?

The ”true north” for our operations is to constantly meet the quality requirements we have set for all of our products, regardless of the capacity and lead-time goals that we set; our manufacturing, supply chain, and product release processes have been created and continuously improved with this in mind.

What measures have been taken to ensure consistent product delivery timelines and quality assurance amidst the evolving cleanroom operations?

On top of this, we use Lean Management tools such as 5S, Visual Management, and Tier reviews to ensure consistent product delivery timelines. We also have qualified operators for the manufacturing of our entire product range, and combined with the modular layout of our cleanroom this gives us flexibility to meet our customer demand.     

2022 expansion of Univercells Technologies’ Nivelles site tripled production and R&D capacity

Looking ahead, what do you foresee for Univercells Technologies in relation to cleanroom operations?

Our operations continue evolving alongside our customers’ needs. We anticipate qualifying our cleanrooms to EU Grade D in the coming years, and we have engineered additional filtration capacity into our HVAC system design. The evolution of customers through our product line from scale-X™ hydro to scale-X™ nitro will shift our focus in manufacturing and necessitate adapted equipment. The Nivelles cleanroom expansion project completed in 2022 positions us as an innovative company, constantly adapting to the evolving needs of the industry whilst maintaining highly competitive lead times.

About our expert

Gareth joined Univercells Technologies in November 2021 as Head of Manufacturing and Supply chain and is the Operations Director since January 2023. He and his team ensure the completion of development of our cutting-edge technology portfolio whilst guaranteeing competitive lead-time product supply to the vaccine and gene therapy markets. Since January 2024 Gareth has expanded his role to cover Operations of the Donaldson Life Sciences Bioprocessing Equipment business as a whole.