CleanBoy® Medical – a particle- and germ-free cleanroom workbench for medical-technical applications

Particles and germs are ubiquitous in ambient and indoor air. Only through proper cleaning of the room air can suspended particles be removed from the air. Among the various technical options for cleaning room air, filter techniques have proven particularly effective because they offer an affordable and cost-efficient alternative in operation and can also be retrofitted later.

The cleanroom workbench CleanBoy® Medical was specifically developed for use in clinics, medical practices, pharmacies, and clinical laboratories. The device offers the possibility to create cleanroom and hygiene conditions wherever they are needed with minimal investment. The device requires no installation – it is ready for operation within a few minutes.

The CleanBoy® Medical has been tested by the Fraunhofer Institute for Production Technology and Automation (IPA) and certified as a medical device with cleanliness class B. This means that, according to the GMP guideline, Annex Biocontamination, no more than 5 CFU (colony-forming units) should be detectable on sedimentation plates (diameter 90 mm) after 4 hours of operation within the cleanroom workbench.

The CleanBoy® Medical contains the same "inner workings" as the standard CleanBoy® series from Spetec GmbH. The main feature is that all housing parts are made of stainless steel. Corners and edges are rounded to facilitate cleaning of the device surfaces. All joints are sealed to prevent germ nests. Only materials resistant to common disinfectants and cleaning agents are used.

The core of the cleanroom workbench is the long-established filter technology of Spetec GmbH. In a filter unit, a laminar airflow is generated that acts like a dense curtain, protecting the clean interior from particles and germs from outside air. The device includes a high-performance HEPA H14 filter. This has an efficiency of 99.995%, meaning that at a particle size of 0.12 μm, the filter removes at least 99.995% of all particles and germs. With the H14 filter, the Spetec CleanBoy® Medical has an isolation factor of 10,000. This means that the air quality in the workspace is improved by at least a factor of 10,000 compared to the surrounding air.

A significant effect of the filtered cleanroom atmosphere is the drastic reduction of the germ count within the work surface. Conditions in the work area of the bench are practically sterile. Viruses, bacteria, yeast, and molds do not float individually in the room air but are usually attached to particles or transported via aerosols. When these germs are filtered out of the air, a practically germ-free atmosphere is created in the workspace. All surfaces are designed for hygienic cleaning and disinfection. Particular emphasis was placed on meeting the design and concept recommendations of EHEDG, ISO 14159, and 172-2. The cleanroom workbench is therefore recommended for the pure and hygiene-critical manufacturing, processing, filling, and packaging of pharmaceuticals, medical-technical, and sensitive goods.