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The news of SPETEC GMBH

CleanBoyâ Medical – a particle-free, sterile clean-room work-bench for any application in the field of medical technology

août 03, 2021

Decontamination enclosure
The CleanBoyâ Medical clean-room workbench was developed specifically for use in hospitals, doctors’ surgeries, pharmacies and clinical labs. 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.
The “innards” of the CleanBoyâ Medical are the same as those of the standard CleanBoyâ range from Spetec GmbH. The main feature is that 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 so as to offer no potential bacterial breeding ground. All the materials used are resistant to commonly used disinfectants and cleaning agents.
The CleanBoyâ – 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. 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 air flow 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 CleanBoyâ – 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.
One important effect of the filtered clean-room atmosphere is that the microbial count in the working space is also reduced dramatically. 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 and particular attention was 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.
CleanBoyâ Medical – a particle-free, sterile clean-room work-bench for any application in the field of medical technology
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How to protect products from aerosols, dust particles or germs?

mars 03, 2021

Food safety
All three groups of particles have one parameter in common and this is its hydrodynamic diameter, and if this is below 30 μm they can be transported over long distances or float in the room air for minutes. In production facilities humans are producers of aerosols (tiny droplets) and particles (skin particles and fibers from clothing), too. Many of these particles can impair product properties in production or packaging or even destroy optical or electronic components.
This is the reason why sensitive products must be protected from dust or micro-organism under cleanroom conditions and thus filter technologies are inexpensive and cost-effective in removing particles from air. This applies to entire clean rooms as well as to smaller filter units, so-called laminar flow boxes, because both systems are based on the same high-performance filters which can reduce particles (dust, microbes, germs, aerosols), because this process depends only on hydrodynamic but not on chemical or biological properties.
A laminar flow box, such as the FBS series from Spetec GmbH, has been tested by the Fraunhofer Institute for Manufacturing Engineering and Automation, and was classified according to DIN standard EN ISO 14644 in class ISO 5. This means that not more than 3,520 particles per 1 sqm can be detected inside the box improving air quality by at least 10,000 times.
All airborne microorganisms and dust particles are omnipresent in air. Thus, filter technologies are essential in food industry, optical, electronic and in pharmaceutical and medical production facilities, where also sterility plays an additional role, but again germs are omnipresent. Therefore, medical devices such as syringes, scalpels or bandages and plasters must be sterilely packaged and stored. Finally, we can conclude that air filters serve to protect our health and our products quality.
How to protect products from aerosols, dust particles or germs?
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Reduce the germ loas using Spetec cleanroom technology!

novembre 15, 2020

Clean room
Due to the corona crisis in spring 2020, the topics of hygiene and germ contamination have become even more relevant, so that practically all areas of economic life are affected.
Spetec cleanroom products have a proven effect to reduce the number of germs. Offices or laboratories become considerably low in germs or nearly germ-free by air filtration, e.g. with a laminar flow system from Spetec.
In less than three minutes a Spetec FMS 75 Laminar Flow Module, for example, will clean the entire air in a 20m² room, filtering 99.995% of all particles - based on a particle size of 0.12 µm according to MPPS.
Bacteria, yeast and moulds do not float in the room air as individual clusters of molecules, but generally adhere to particles. If these particles are separated from the air, a practically germ-free atmosphere is created.

Comparison of germ counts in a production hall and in Spetec cleanroom systems:
 
Test Laminar Flow Box

(germ load/m³)
Production environnement
(germ load/m³) outside
 
(germ load/m³) bacterial count < 1 230 60 yeast / moulds < 1 100 1190        

Press contact
 
Spetec GmbH
Am Kletthamer Feld 15
85435 Erding
Telefon +49 8122-95909-0
Telefax +49 8122-95909-55
spetec@spetec.de
www.spetec.de
Reduce the germ loas using Spetec cleanroom technology!
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