Medres’s new manufacturing site in Hungary marks a major step in expanding our CDMO capacity — with 600 m² of ISO Class 8 cleanrooms for device assembly and molding, and 1,300 m² of manufacturing space for prototyping, PoC medical device production, and logistics.

A key milestone in launching the site was the Cleanroom Environmental Qualification (CER) — a rigorous validation process confirming that every cleanroom meets the environmental and performance standards required for medical device manufacturing.

We spoke with Andrea Herczeg , Director of QA/RA Advisory Services at Medres, who led the qualification process, about how it was done and why it matters.

How did Medres approach the qualification?

 Our aim was to validate the cleanroom environment step by step — from design integrity to consistent, compliant performance in daily operation. The process followed ISO 14644 and GMP standards, starting with Design Qualification (DQ) and concluding with Performance Qualification (PQ).

What happens in the DQ phase?

DQ verifies that the cleanroom design meets both regulatory standards and our User Requirement Specification (URS) — covering elements such as clean room construction, surface integrity, layout design and manufacturing aspects.

What does Installation Qualification (IQ) confirm?

Following DQ, the IQ phase ensures that the facility and the equipment has been installed correctly  according to the manufacturer’s specifications, design documents and GMP requirements. As in the other phases, it involves preparing and approving the IQ protocol and report, confirming proper installation and full documentation traceability.

“IQ is where design becomes reality — it is the stage where we verify that what was built accurately confirming that the as-built system fully complies with the approved and validated design.”

How is Operational Qualification (OQ) performed?

Once the IQ phase was completed, we moved on to the Operational Qualification (OQ) — assessing cleanroom performance under “at-rest” conditions, meaning systems are running but no personnel are present.

We measured two groups of parameters:

• Physical: including airborne particles, air pressure, filter integrity, temperature, humidity, and compressed air
• Microbiological: including air, water, and surface samples

All areas met ISO Class 8 and GMP requirements, documented through released, executed, and approved OQ reports — enabling us to proceed to PQ.

And what is Performance Qualification (PQ)?

PQ confirms that the process can consistently operate within validated limits. It demonstrates performance under real working conditions — with all processes, equipment, tooling, and trained personnel in place.

We test under worst-case scenarios, operating  all relevant production and supporting processes. Physical and microbiological monitoring is also performed, including personnel hygiene testing (garments and hands).

As a CDMO transferring production from an older facility, we additionally verified process equivalence to confirm consistent quality and compliance with customer requirements.

What role does bioburden testing play?

It’s the final confirmation and a highly significant step — microbiological testing of products manufactured in the cleanroom. A successful bioburden test proves that the environment and processes are stable, and supports the effectiveness of sterilization.

How is the validated state maintained?

All parameters — including air pressure, temperature, and humidity — are monitored by our validated Environmental Monitoring System (EMS). EMS continuously tracks parameters and trends data in real time, issuing alerts at warning or action levels.

We placed a strong emphasis on the software validation of the Environmental Monitoring System (EMS), ensuring comprehensive coverage of all parameters that directly or indirectly influence the cleanroom’s performance and operational integrity. Our goal was to confirm that the EMS not only meets regulatory and quality requirements, but also provides reliable, traceable data to support continuous control of the cleanroom environment.

We also perform periodic requalification, including physical and microbiological sampling, as well as bioburden testing to confirm long-term compliance.

What does this successful cleanroom validation mean for Medres and its partners?

The CER validation is more than a compliance step — it’s a foundation for reliable, scalable, and high-quality medical device production. It ensures that every product leaving our cleanroom is built in a controlled, validated, and continuously monitored environment.