"Different industries - different requirements. We have compiled comparisons, regulations and developments for you."
Roman Czech, MBA - Senior Consultant Cleanroom Technology Austria
FAQ - Cleanroom technology in various industries
Q
How important is cleanroom technology in the various industries?
Pharmacy
The pharmaceutical industry is certainly the sector that uses cleanroom technology to the greatest extent. This is because inadequate use of cleanroom technology can endanger human lives in this industry.
The GMP guidelines not only specify requirements with regard to cleanroom classes, but also strict rules for the equipment in the cleanroom (walls, floors, machines, etc.) and the production process. Unfortunately, it is only partially possible to achieve a strict separation of people and product (especially filling). This means that the biggest disturbance in the cleanroom is usually people.
Regulations: GMP guidelines, ISO 14 644, partly still US.Federal Standard 209e
Equipment: Laminar flow, partly isolators
Trend: constant, higher requirements for cleanrooms are not necessary
Microelectronics
Microelectronics places the highest demands on cleanroom technology in terms of air purity. Nowadays, electronic components are so small that the smallest particle on the surface leads to a fault and subsequently to the product being rejected.
However, as the production process is usually carried out mechanically, it is possible to protect the product from external contamination by means of enclosures (minienvironments). Filter-fan modules, which are usually mounted above, ensure a flow of ultra-pure air through the interior and thus remove contaminants (metal abrasion) that arise during the work process to the outside. PTFE-free ULPA filters of class U16 and U17 are standard. In most cases, activated carbon cells are even placed in front of them to filter odorous substances (which are also particles) out of the air.
Regulations: IES-RD-CC00.., IES-RP-CC0..., ISO 14 644, partly still US.Federal Standard 209e
Systems: isolators (minienvironments), FFU
Trend: increasing requirements for air quality, but minimized cleanroom zones
Medical technology
In medical technology, the term cleanroom technology is not really appropriate. It is the absence of germs that is required, not the absence of particles. However, airborne germs adhere to particles and thus enter the wound field. Keeping particles away therefore means protecting against airborne germs.
On the other hand, the surface germs. These are transmitted via contact. Most of the material that comes into contact with the wound during an operation can be sterilized. Although surgical instruments, implants, sterile dressings etc. are produced under cleanroom-like conditions, the requirements for this are very low. Although laminar flow systems above the operating table are prescribed for the actual operation, the functionality and testing of these are not. The development of a precise test procedure for LF systems, in which a complete operating theater operation is simulated, could mean the introduction of cleanroom technology into medicine. See ÖGHMP and SWKI.
Regulations: Medicinal Products Act, ÖNORM H6020
Systems: laminar flow, safety cabinets
Tendency: slowly increasing
Food
The food industry has so far paid little attention to cleanroom technology. However, it is a fact that the low-germ production of food extends the shelf life of products.
Studies are currently underway to investigate which cleanroom technology will lead to the desired result. These studies are being conducted by the Food Testing Institute (LVA) in cooperation with the Research Promotion Fund (FFF). See also www.lva.co.at
Regulations: none
Systems: Laminar flow, FFU
Tendency: slow coming
Precision mechanics
Even in mechanics, there are limits without cleanroom technology. Space technology, watches, miniature gears...
Regulations: none (mostly from the customer)
Systems: laminar flow, FFU
Tendency: growing
Microbiology
Cleanroom technology has long been at home in microbiology. Safety cabinets and clean rooms are now standard in a laboratory.
Regulations: Various
Installations: Safety cabinets
Tendency: growing
Optics
The manufacture of contact lenses, photographic technology, microscopes, lasers....etc. requires the cleanest environment. However, this can usually be achieved in a small space.
Regulations: Device-dependent
Systems: Safety cabinets, laminar flow, FFU
Tendency: growing
Send us an inquiry!
Do you have questions about our products or services?
Please fill in the form opposite. We will endeavor to contact you as soon as possible and answer your questions.
For telephone inquiries: +43 (0) 2236 320053- 0
