The structure of the CleanBoy Medical is based on the standard CleanBoy series from Spetec GmbH. All housing components are made of stainless steel and the corners and edges have been rounded for easy cleaning of the unit's surfaces. The seals are also sealed to prevent bacterial growth. The materials used have been tested to resist commonly used disinfectants and cleaning agents. Tested by the Fraunhofer Institute for Manufacturing Engineering and Automation (IPA), the CleanBoy Medical has been certified as a Class B cleanroom medical device. The "Biocontamination" annex of the GMP guidelines specifies that there should be no more than 5 CFU (colony-forming units) on the 90 mm diameter decantation plates at any point on the cleanroom worktable after 4 hours of operation.
Spetec's filtration technology provides 10,000 times better air quality in the work area than ambient air
A laminar airflow is created in a filter unit equipped with a high-performance H 14 filter capable of capturing at least 99.995% of all particles as small as 0.12 µm. This allows the CleanBoy - Medical to offer an isolation factor of 10,000. The number of microbes in the workspace is thus significantly reduced with conditions inside the workbench being virtually sterile. All surfaces have been designed to allow hygienic cleaning and disinfection and meet the design recommendations established by the EHEDG and in the ISO 14159 and 172-2 standards. The cleanroom workbench is therefore suitable for the sterile and hygienic production of drugs and medical products.
