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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
- Full-area filtration
- Easy installation, maintenance and disinfection
- Low initial pressure drop of HEPA filters
- Air recirculated via economical EC motors
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Fresh Breeze – FAN FILTER UNIT
- Full 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
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AIR SHOWER
- Decontamination is performed by clearing off dust and dirt particles from bodies of cleanroom personnel
- Maximum efficiency through a high-velocity turbulent jet of clean air of 25 m/s
- Cleaning cylce with pressure control, door blocking and user control settings
- Filtration using a pre-filter and HEPA filter
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CGx Ceiling Air Outlet HEPA FILTER DIFFUSORS
- For turbulent displacement flow
- Suitable for all types of suspended ceilings produced for clean rooms
- Vertical or horizontal inlet with a possible filter integration
- Round or rectangular duct connection
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SANDWICH PANELS
- Painted or stainless steel sheet facing, custom design colours, various cores with no release of particles
- Matching flush glazed glass panels for non-opening windows and each panel type with rounded connections to floor and ceiling
- Easy maintenance, effective sanitation and resistance to disinfectants
- Guaranteed resistance to positive pressure of 200Pa, also for negative pressure applications and all classes of clean rooms
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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 anaesthetic 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
RS Panel ceiling (sandwich panels) is a part of a complex industrially made modular system designed as a building-in for clean rooms. RS Panel Ceiling is a walkable ceiling with a payload of 150 kg/m2. It is suitable for assembly and service / inspections, but not intended for carrying the weight of HVAC units etc. Attention must be given nearby openings (cut-outs). RS ceiling is made of sandwich-type (glued) panels with analuminum border section frame, measuring 62 mm in thickness. The face material consists of a 0.75 mm thick steel zinc-plated sheet, painted with PES varnish in shade RAL 9010 semi-matte finish and protected by a cover foil. Optionally the face material consists of a 0.80 mm thick stainless-steel sheet V2A with surface treatment SB (brushed). The core filling is composed of mineral wool with perpendicular fibers, with a thickness of 60 mm and a specific weight of 100 kg/m3, glued with an expansive single-component polyurethane adhesive. Wall/ceiling connection is covered with R30 aluminum radius profile R30, fastened in combination with profile L-20x30-2500. Joints between panels are sealed with silicone. LS Light ceiling (clip-in) features a lightweight construction, although overpressure in a clean room up to 50 Pa is possible. This ceiling has an absolutely flat surface, as the suspending elements are hidden above the modules and enables easy cleaning. LS Light Ceiling consists of a double-layer load-bearing grid with an axial span of 600 x 600, 625 x 625 or 675 x 675 mm. The top and bottom layers of the grid are made up of locking profiles (clip-in solution) and are connected to each other using fixing lugs. LS cassettes made from 0.5 mm thick galvanized steel sheet, finished on the visible side with a 25 μm thick polyester semi-matte paint RAL9010, are inserted into the bottom locking profiles and, along the perimeter ofthe room, into aluminum end profiles (profile F, radius profile RF). Joints are sealed with silicone. KS Cassette ceiling (grid) is designed for higher classes of clean rooms and feature a rigid construction. This allows high over and under pressure in a clean room. A characteristic feature of the KS ceiling is the grid made of KSL profiles, visible from the room level. The cassette ceiling (KS) consists of a load-bearing grid made from aluminum KSL profiles, with an axial span of either 1380 x 690 mm or 690 x 690 mm. The KSL profiles, coated in RAL 9010 varnish, are connected to each other using KSL couplers. KS cassettes are made from 1.0 mm thick galvanized steel sheet, finished on the visible side with a 25 μm thick polyester semi-matte paint (RAL 9010). KS Cassettes are integrated with the grid structure from the top (secured by KSL clamps), and along the perimeter of the room, Finish-cut Cassettes are inserted into aluminum end profiles (profile F/radius RF/radius R30+L30x20). Joints are sealed with silicone KSH Alucore ceiling (grid) with honeycomb aluminum cassettes (Alucore) and a robust design, the KSH ceiling can bear a load of 150 kg/m², allowing for walkable access from above. KSH ceiling consists of a load-bearing grid made from aluminum KSL profiles, with an axial span of either 1280 x 690 mm or 655 x 690mm. The KSL profiles, coated in RAL 9010 varnish (RAL 9003 on request), are connected to each other using KSH couplers. KSH cassettes are made of sandwich panels performed in Alucore material (honeycomb aluminum structure) with a thickness of 10 mm. Cover sheets are made of aluminum alloy and the sheet core is performed as aluminum honeycomb. Both sides are platinum white with a polyester paint (approx. RAL9003). Cassettes are integrated with the grid structure from the top (secured by KSH clamps) and, along the perimeter of the room, are cut to fit into KSLprofile, which is fastened to strip L30x20 and covered by aluminum radius profile R30. Joints are sealed with silicone.
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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
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