A particle-free, sterile clean-room workbench for applications in the field of medical technology 

The CleanBoy® Medical clean-room workbench was developed specifically for use in hospitals, doctors’ surgeries, pharmacies, and clinical labs.

The CleanBoy® Medical has been tested by the Fraunhofer Institute for Manufacturing Engineering and Automation (IPA) and has been certified as a clean room grade B medical device. This means that, 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.
The “innards” of the CleanBoy® Medical are the same as those of the standard CleanBoy® range from Spetec GmbH:

  • The main feature: All components of the housing are made from stainless steel. All corners and edges have been rounded to facilitate cleaning of the surfaces of the unit. All joints have been sealed to offer no potential bacterial breeding ground. All the materials used are resistant to commonly used disinfectants and cleaning agents.

  • At the heart of the clean-room workbench lies Spetec GmbH’s tried and tested filter technology. The unit features an HEPA H 14 high-performance filter. This has a filtration efficiency of 99.995 %, meaning that the filter captures at least 99.995 % (99.9995 %) of all particles of a size of 0.12 µm (0.3 µm).

  • Thanks to the use of the H 14 filter, the Spetec CleanBoy® Medical has an isolation factor of 10000. This means that the air quality in the work area is at least 10000 times better than that of the ambient air.

  • One important effect of the filtered clean-room atmosphere is that the microbial count in the working space is also reduced dramatically. This means that conditions within the working area of the workbench are virtually sterile. The table shows the microbial count directly in the flow of purified air. 

    Table microbial count v1

  • If these microbes like viruses, bacteria and yeasts and fungi 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 and particular attention was paid to meeting the design recommendations laid down by the EHEDG and in ISO 14159 and 1672-2.

The clean-room workbench is therefore recommended for the sterile, hygiene-critical production of medicinal and medical products. The unit makes it possible to create clean-room 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.


High performance filter

The Spetec CleanBoy® Medical uses a type H 14 filter. It features a retention rate of 99.995%. This means that at a particle size of 0.12 μm (according to MPPS), the filter removes at least 99.995% of all particles. At a particle size of 0.3 μm, the retention rate is approx. 99.9995%. By using the H 14 filter, the Spetec laminar flow box FBS has an isolation factor of 104. This means that the air quality inside the laminar flow box is improved by a factor of at least 10 000 relative to the ambient air.

 

 

 

 

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