The Classification of Cleanrooms at Regionshospitalet Gødstrup

The Classification of Cleanrooms at Regionshospitalet Gødstrup

Regionshospitalet Gødstrup is part of a larger overhaul of hospital operations in the Midt- and Vestjylland region. The hospital is soon ready to open its doors, and in this connection, Holm & Halby's technicians are completing the final part of the cleanroom classification.

This article is written by Bent Grønlund from Modpol, who participated in a workday with two of Holm & Halby's technicians.

The GPS was set to Kapelvej 5, Gødstrup in Herning, and on this windy Tuesday morning, I had an appointment with Finn. After navigating through several detours among many construction vehicles, I met him in the parking lot outside the hospital. It was not our first meeting, so we briefly discussed our last visit to Aalborg. Finn led me through the hospital's long corridors to the day's first of many dress changes.

Holm & Halby's technical expertise extends far beyond the repair and service of equipment

At the hospital, technicians Finn and Michael have thoroughly tested the cleanrooms that must meet predetermined classification requirements. From the builder's side, a lot of work has gone into designing the various cleanrooms, but when thoughts and ideas need to be transformed from the drawing board to the real world, many things can change. Therefore, Holm & Halby conducts extensive testing and documentation before the rooms can finally be put into use.

After several dress changes, I found myself in "the holiest of holies." A brand-new cleanroom with state-of-the-art LAF cabinets. Here, I was introduced to Michael, whom I only recognized at lunch – after yet another series of dress changes. At this point, Finn and Michael had been working on the classification of the cleanrooms for several months and were, as usual, eager to tell me about what it all entailed.

Cleanroom Classification

The process takes place in several stages to ensure ongoing oversight.

It starts with a simple review of the obvious challenges. The rooms at Regionshospitalet are bright and inviting with plenty of natural daylight from the windows, and here, the requirement is that the window glasses are double-glazed.

Particle measurements of the rooms are conducted before placing the LAF cabinets to ensure that the ventilation is functioning as intended. Once the LAF cabinets are placed and connected to the ventilation, they are tested, and the software changes specific to Regionshospital Gødstrup's requirements are updated on the cabinets.

The process is documented through a comprehensive documentation package - IQ/OQ.

During Installation Qualification (IQ), the LAF cabinet is tested to ensure that software and hardware are installed correctly, and both the electrical and flow line connections work optimally.

Operation Qualification (OQ) documents that the LAF cabinet operates according to the regulations. The OQ procedure confirms that the instrument meets all relevant and known specifications in the environment where it will be used. The OQ procedure follows immediately after the IQ procedure.

Particle counting of the room itself is again conducted - with up to ten measurement points. Each session lasts 30-40 minutes, as the room needs time to stabilize between measurements to achieve optimal measurement results. All measurements are, of course, documented - either as files or printouts.

The morning was spent reviewing and updating the LAF cabinets. After a lunch with exquisite sandwiches from the local gas station, we began the afternoon's program - smoke testing. We were joined by a representative from the Midt- and Vestjylland region, who monitored this part of the test. Enveloped in smoke and steam like King Christian, every corner of the rooms was tested with smoke. The airflows then became highly visible - both in the cabinets and in the room itself.

In addition to the room itself, the ventilation inlets in the ceiling are also measured. Pressure differences on both sides of the HEPA filters are measured. Later, a visual smoke test is conducted in both the cabinets and the room. The test is very practical but highly effective. Smoke from a small smoke cannon is laid along the floor, especially at places considered problematic. Typically, the smoke disappears with the ventilation - either in the cabinets or through the general extraction. If there are places where the smoke "lingers," it indicates that action should be taken. All smoke deployments are carefully documented on video recording.

The particle measurements are time-consuming, the smoke tests require meticulousness, and the updates and tests of the LAF cabinets are extensive, but some of the major hurdles in the technician's workday are the clothing changes - up to 14-16 times per technician - required when working in cleanrooms.

……..and then there was the fire alarm

It was triggered by a smoke test… A misunderstanding from the hospital's alarm center. However, the fire brigade was quickly reassured, and once they ensured that there was no fire, they returned home. I could also head home after a long day filled with impressions and information from the two eager technicians – and more dress changes than Copenhagen Fashion Week…