Building the medical clean room in North America

An Interview with José Fuentes Part 2 – Building the Clean Room

This part of the interview covers the timeline and challenges faced while constructing the new clean room in Mexico for the new project. José elaborates on the process of meeting quality requirements according to ISO 13485 and the certification process. He also discusses the involvement of the Swiss team and the smooth execution of the project.

 

Viola Frey

Is the project in Mexico basically a twin of the Rapperswil project?

José Fuentes

That’s correct.

Viola Frey

How long did it take you to build the clean room, from planning to finishing it?

José Fuentes

We started in March 2023 this year and finished in August 2023.

Viola Frey

So that’s pretty quick, isn’t it?

José Fuentes

Yes, indeed, it took about six months and was an impressive project building construction.

Viola Frey

How was the project set up for the new clean room?

José Fuentes

We had a project leader from Mexico, Lourdes Labastida, our project manager. From the Swiss side, Roger Wolf from the technical department supported us. I was responsible for all quality issues.

Viola Frey

What were the main challenges in meeting all quality requirements according to ISO 13485?

José Fuentes

The real challenge from a quality perspective is demonstrating that once the new clean room is built and completed, it will be classified according to ISO 13485:2016. So, in that sense, we achieved our initial clean room certification from an external company that was in charge of a series of tests performed to show that it was operating at its required class.

The certification process checks the following parameters: temperature, humidity, pressure, and degree of purity (suspended dust in one cubic meter of air). It also checks whether the contamination class, air velocity, pressure, and flow rate comply with the project requirements.

From my perspective, this was the biggest challenge in building the new clean room, as quality is Weidmann’s top priority. Our unwavering commitment guarantees that every product is crafted to precise specifications, prioritizing patient care throughout the process.

Viola Frey

So, did this external company that was checking all those parameters issue official documentation to verify the clean room’s proper functioning?

José Fuentes

Yes, the documentation issued ensures that our new clean room complies with ISO and current Good Manufacturing Practices (cGMP) standards.

  • A note: As this is a new clean room, the state of the clean room occupancy falls under “as-built,” i.e., a brand-new clean room environment that has never been used. In this state, the room is at its cleanest. The installation is complete, and the services are functional, but no materials, production equipment, or people are present.

Viola Frey

It was a very quick project, but were there any difficulties along the way when you thought there would be delays, or were there any unexpected challenges in building the clean room?

José Fuentes

I have to say that it was really impressive since everything within this particular project was according to the timeline.

We didn’t have any real problems from a quality point of view because we were able to separate the new clean room construction from the current series production, which meant that they didn’t interfere with each other, e.g., the warehouse, material flow, packaging materials, or finished goods. That made it easier to manage and allowed us to meet the schedule. 

Viola Frey

What do you think made the project so smooth?

José Fuentes 

It was also very important for us to have the support of the Swiss team at all times. To accomplish this task, we received a lot of feedback from the quality department and the project manager responsible for the project in Switzerland.

Viola Frey

Thank you for your time today. I look forward to our next catch-up about sustainability considerations for the clean room and future plans.

Read the first installment of this interview series here.