- FläktGroup
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- Medical device manufacturing Clean Rooms
Clean Rooms & Medical device manufacturing
The creation of medical devices requires a totally clean and germ-free indoor space.
Medical device manufacturing
Medical devices are used for “working” on human body’s – therefore they must be sterile. Production of these devices is undertaken within a controlled environment.
Clean air in this environment is a must, and there must be a controlled level of airborne particles without and leakages of undesirable substances or aerosoles.
We offer efficient heat-recovery systems and reliable filter systems with low pressure drop assure considerable energy savings. We deliver turnkey solutions on a one-stop shopping basis: beginning with building elements such as ceiling grid modules, filter and panel ceilings, laminar-flow ceilings, clean room walls, wall paneling, windows and doors – including development and installation of your clean room facilities – and extending to after-sales service.
Contamination Control
- Supply air needs to be filtered in three stages with a HEPA filter at the third stage
- Low turbulence airflow above critical areas (almost laminar)
- Overpressure to the neighbouring rooms needs to be maintained at ca. 15Pa
- All surfaces inside of the room should be smooth and easy to clean – rounded corners, reduced numbers of joints
Clean Room Technology by FläktGroup
Numerous international manufacturers work with FläktGroup‘s Clean Room Technology as a result of our expertise in developing reliable and effective contamination control methods for Clean Rooms.
Clean Room solutions from FläktGroup permit users to coordinate all critical parameters precisely with the requirements of respective production processes and to systematically control decontamination of room air. These solutions control air pressure, temperature, and moisture – especially the contamination with fine dust, skin particles and bacteria – and keep these contaminants away from products and processes.
Effective and precise clean rooms design is essential for semiconductor production and pharmaceutical industries, as well as companies in the chemical industry, space technology, and optics and laser technology perform research and production; where we see that conditions in these industries are increasingly relying upon Clean Room conditions.
Technical, chemical, and biological quality products with highly sensitive manufacturing processes are further processed in hermetically sealed areas that demand room air that is virtually dust-free. The manufacturing process itself, however, requires ambient air absolutely free of particulates.
Our Process
We offer a full portfolio of support every step of the way from 3D design to installation, to reports in order to develop your bespoke project.
With decades of experience in clean rooms, we bring the necessary expertise into your project and help you to create an optimal concept for the clean room, which is energy efficient and reliable.
Once the clean room layout is finalized, we create a 3D model with all little details – to the last screw.
For you to check – and for our production.
All our factories work with the 5S approach and have a best-in-class on-time delivery rate.
In our modern facilities we produce fast standardized products, but are flexible to support you with customized solutions.
The installation is a crucial part in the process. Especially for a clean room. Hence, we have very well trained teams in our core countries. Everywhere else, a supervisor from the factory will be present during the whole installation phase.
We support the finalization of your project by bringing in our long-term partners. You will get a full report, which is complying to all global and local regulations and standards. And – of course – you can be ensured, that your clean room will operate as required.
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Products
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EHSD CIRCULAR FLOW VARIATOR
- Easy and Quick Selection
- Insulated casing
- Integrated orifice plate for air measurement
- FG compact controller as standard
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CAIRplus AIR HANDLING UNIT
- CAIRplus is the tailor-made premium range of modular air handling units for every customer requirement
- Environmentally-friendly design means an energy recovery system with high efficiency is available for every configuration
- Clean surfaces and ease of cleaning guarantee hygienic standards to VDI6022
- All units can be supplied with FläktGroup integrated controls ISYteq 4.0
- T2/TB2/L1/D1 Eurovent certified casing
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Fresh Heaven MAXX LAMINAR AIRFLOW UNIT
- Size upon Customer’s demands
- Air delivered by AHU (FHM) or recirculation mode with power module (FHM P)
- H13, H14 or U15 filters with U-shaped or fluid gasket
- Casing in stainless-steel / steel in RAL 9010, height 450 mm (FHM) / 550 mm (FHM P)
- Various outlets (perforated stainless-steel / steel in RAL 9010, polyester fabric)
- Equipped with autonomous automatics (local control via Siemens LOGO! panel)
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Fresh Breeze – FAN FILTER UNIT
- Full area filtration
- Energy efficiency is ensured through EC fans
- Own production of HEPA and ULPA filters to perfectly match unit design
- Low initial pressure drop of filters
- Various air-outlet types
- Independent control unit
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AIR SHOWER
- Decontamination is performed by clearing off dust and dirt particles from bodies of clean room personnel
- Maximum efficiency through a high-velocity turbulent jet of clean air of 25 m/s
- Cleaning cycle activated by PIR-motion sensor, door blocking, and user control settings
- Filtration using a pre-filter and HEPA filter
- Up to 3 rooms can be interconnected
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GLFC 2150-2600 DA2 (286 - 1212 kW)
- Version with 2 screw compressors
- SEPR-HT values up to 6.3
- ErP 2021 compliant with EU 2016/2281
- Available as Standard or Super-Low noise (SL) versions
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CGx Ceiling Air Outlet HEPA FILTER DIFFUSORS
- Used in pharmaceutical industry, laboratories, hospitals, microbiology, electronic industry, and food industry
- Easy integration in all types of FläktGroup suspended ceilings
- Filter classes H13 to U15 in an aluminum frame, with dry or fluid seal
- For turbulent displacement flow
- Integrated pressure-gauge connection for monitoring pressure drop
- Tube for applying test aerosol (measuring of concentration)
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SANDWICH PANELS
- The panels have a sandwich structure (two steel sheets with thermal insulation between them), with painted or stainless-steel sheet facing
- Custom colors and various core options are possible with minimal particle release
- R-panels 62 mm thick, M-panels and Me-panels are 60 mm thick
- Matching flush glassed-in panels (non-opening windows) and doors are available
- All joints are sealed by permanently elastic silicone in a color closely matching the panel color
- Round connections to the floor, suspended ceiling, and inner corners (Radius profiles system) are available
- The panels offer easy maintenance, effective sanitation, and resistance to disinfectants
- They ensure tightness to maintain over pressure or under pressure in the clean room
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Inwall FACINGS
- The ideal solution for adapting existing rooms into clean rooms.
- Easy and quick fixation to structural walls
- All panels are prefabricated – minimal adjustments on site
- All joints sealed with silicone
- Panels connected via conductive cables are grounded to the earthing point
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DOORS & WINDOWS
- An automatic drop-down seal integrated into the door leaf enhances the air-tightness of a door
- Being flush with sandwich wall partitions ensures easy maintenance and flawless disinfection
- An interlock system equipped with signaling units prevents both doors in an airlock room from being opened simultaneously, effectively reducing the risk of contamination
- Doors can be opened manually or automatically with automatic drive
- Transfer doors are used as partitions of transfer boxes (passive or with filtered airflow)
- Accessories available include automatic drives, door closers, mirrors, windows with sunblinds, windows made from float glass or safety glass (ESG, VSG), automatic drop-down seals, stainless-steel kick plates, electromechanical and electromagnetic locks, signaling panels (semaphore), and many more.
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EXHAUST-AIR COMPONENTS
- Reliable ventilation of anesthetic gases, particles and exhaust of room air burdened with microbes
- Various choices of extract-air components
- Seamless integration of extract-air components in all types of wall panels and facings
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CEILINGS
- LS ceiling – clip-in light ceiling
- KS ceiling – grid cassette ceiling
- KSH ceiling – walkable Alucore grid ceiling
- RS ceiling – walkable sandwich panel ceiling.
- A minimum number of particles is released from the panel surface
- Ease of installation, cleaning and sanitation, resistance to conventional disinfectants
- Joints between cassettes are sealed using permanently elastic sealant
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eQ MASTER® AIR HANDLING UNIT
- Tailor made for customer needs
- Energy Efficient and optimized with integrated control
- Large variety of high efficiency components