Spetec CleanBoy Plus cleanroom workbench
Cleanroom workbench in stainless steel design according to GMP
The CleanBoy Plus cleanroom workbench was developed for use in workplaces where hygiene plays the main role.
The CleanBoy Plus has been tested by the Fraunhofer Institute for Manufacturing Engineering and Automation (IPA) and certified as a medical device with cleanliness class B . This means that according to the GMP guidelines, Annex Biocontamination, no more than 5 CFU (colony forming units) may be detected on sedimentation plates at any point within the cleanroom workbench after 4 hours of operation.
The CleanBoy Plus has the same ''inner workings'' as the standard CleanBoy series from Spetec GmbH:
- The main difference is that all housing parts are made of stainless steel . Corners and edges are rounded so that the appliance surfaces can be cleaned easily. All joints are sealed so that germ nests can be avoided. Only materials that are resistant to common disinfectants and cleaning agents are used.
- The centrepiece of the cleanroom workbench is the filter technology from Spetec GmbH, which has been tried and tested over many years: the device contains a high-performance HEPA H14 filter. This has a filtration efficiency of 99.995%, which means that the filter filters out at least 99.995% of all particles and germs with a particle size of 0.3 µm.
- By using the H14 filter, the Spetec CleanBoy Plus has an isolation factor of 104, which means that the air quality in the working area is at least 10,000 times better than the ambient air.
- A significant effect of the filtered cleanroom atmosphere is that the bacterial count within the work area is also drastically reduced. Practically sterile conditions prevail in the work area of the workbench (see table in Technical data).
- A practically germ-free atmosphere in the work area is created by filtering out viruses, bacteria, yeast and mould from the air.
All surfaces are designed for hygienic cleaning and disinfection. Particular emphasis was placed on fulfilling the concept and design recommendations of the EHEDG, ISO 14159 and 1672-2.
The cleanroom workbench is recommended for the clean and hygiene-critical production of pharmaceuticals and medical-technical products. With little investment, cleanroom and hygiene conditions can be created wherever they are needed. The device requires no installation - it is ready for operation in just a few minutes.
High-performance filter
Type H 14 filters are used for Spetec air purifiers. This has a filtration efficiency of 99.995%. This means that the filter filters out at least 99.995% of all particles with a particle size of 0.12 μm (according to MPPS). At a particle size of 0.3 μm, the separation efficiency is approx. 99.9995%. By using the H 14 filter, Spetec air purification devices have an isolation factor of 10,000, which means that the air quality under the laminar flow module is improved by at least 10,000 times compared to the environment.
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Width:
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901 mm - 1000 mm
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Device type:
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clean benchProduct protection
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Height:
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1301 mm - 1400 mmover 2000 mm
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Cleanroom equipment:
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Clean room station
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Depth:
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801 mm - 900 mm
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| Type |
Clean air flow |
Ambient air |
Outdoors |
| Germ count (bacteria) |
<1 CFU/m3
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230 CFU/m3
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60 CFU/m3
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| Yeast/mould fungi |
<1 CFU/m3
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100 CFU/m3
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1190 CFU/m3
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Spetec Cleanroom Technology Service
As a manufacturer and service provider in the field of cleanroom technology, we offer you a wide range of device variants on the one hand, and fast and universal help with service issues on the other. We have now incorporated our many years of experience as a manufacturer into a range of services that enables us to test, maintain and service your cleanroom systems using state-of-the-art measuring equipment.
The cleanest room air conditions are not only vital in hospital operating theatres. Highly sensitive production environments, such as in semiconductor manufacturing, precision mechanics, optics and optoelectronics, laser technology or food production, also require sufficient indoor air quality. To ensure this, it is necessary to regularly check the flow velocity or perform a filter test.
We offer the following services:
- Particle counting
- Filter replacement for laminar flow boxes (LF unit) of various makes
- Leak detection and elimination
- Volume flow rate determination or Flow velocity
- Temperature and relative humidity measurement
- HEPA filter/filter system installation check
- DEHS leak test
- Clean room validation and certification in accordance with EN ISO 14644 and GMP guidelines
We also carry out EN ISO 14644 certifications, i.e. we record the measurement parameters specified in DIN EN ISO 14644, such as particle count, flow velocity, etc. All these parameters are recorded in the corresponding certificate. All of these parameters are confirmed in a corresponding certificate.
All of the particle measuring devices, air velocity, temperature and humidity sensors we use are tested and calibrated every 12 months.
Our range of services includes service and maintenance work as well as certification of cleanrooms and laminar flow boxes in accordance with current national and international guidelines and standards. These include the VDI 2083 and DIN EN ISO 14644 guidelines as well as US Fed Std. 209E. You will receive detailed documentation of the measurements and a risk assessment.
