Medical Cleanroom Workstation: Sterile. Particle-free. Fast Installation.
Aug 11 2021
Developed specifically for use in hospitals, doctors’ surgeries, pharmacies and clinical labs, the CleanBoy® Medical cleanroom workbench from Spetec enables cleanroom and hygienic conditions wherever they are needed with little capital outlay. It requires no installation and is ready to use in a matter of minutes.
The ‘innards’ of the CleanBoy® Medical are the same as those of the standard CleanBoy® range from Spetec GmbH. All components of the housing are made from stainless steel, with rounded corners and edges to facilitate surface cleaning of the unit. The joints have been sealed which prevents potential bacterial breeding ground. All the materials used are resistant to 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 clean room grade B medical device. According to the Annex ‘Biocontamination’ of the GMP Guidelines, there should be no evidence of more than 5 CFU (colony forming units) on settle plates with a diameter of 90 mm at any point within the clean room workbench after 4 hours of operation.
At the heart of the clean-room workbench lies Spetec’s tried and tested filter technology. A laminar airflow is created in a filter unit. The unit features an H 14 high-performance filter. This has a filtration efficiency of 99.995%, meaning that the filter captures at least 99.995 % of all particles of a size of 0.12 µm. The CleanBoy® Medical has an isolation factor of 10,000. The air quality in the work area is at least 10,000 times better than that of the ambient air.
An important aspect of the filtered clean-room atmosphere is a dramatic reduction of the microbial count in the working space. Conditions within the working area of the workbench are virtually sterile. As a rule, microbes adhere to particles or are transported via aerosols. If these microbes are filtered out from the air, this creates an effectively sterile environment in the working area. All surfaces are designed to allow hygienic cleaning and disinfection with particular attention paid to meeting the design recommendations laid down by the EHEDG and in ISO 14159 and 172-2. The clean-room workbench is therefore recommended for the sterile, hygiene-critical production of medicinal and medical products.
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