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According to ISO 14644, a cleanroom is " A defined space within which the number and concentration of airborne particles is controlled and classified, and which is constructed and operated in a manner to control the introduction, generation, and retention of contaminants inside the space.". In short, every particle in a cleanroom represents a risk of contamination to the final product, which can lead to its deterioration.
Contamination is anything that can have a negative influence on the process, production, and quality of a product. There are many sources of contamination - it can be visible or invisible to the naked eye and can be in solid, liquid, gaseous, thermal, or electromagnetic form. The sources of contamination come from equipment, tools, people, furniture, raw materials, HVAC, room surfaces etc.
The cleanroom class is the level of cleanliness the room complies with, according to the quantity and size of particles per cubic metres of air, depending on the number of particles allowed, your cleanroom will be classified into different ISO categories: The lower the ISO number, the higher their level of cleanliness. These classified cleanrooms will then be used for research purposes, to pack medical devices and of course also to produce products, for example in electronics production, the pharmaceutical industry, automotive, cosmetics, etc.
Over the past 35 years Elis Cleanroom has become a leader in the cleanroom contamination control segment and guarantees a complete and professional supply of clean-processed and/or sterilized cleanroom textiles. We work with you to define and provide a cleanroom protective garment concept, tailored to your needs, select the right cleaning systems, and ensure that your chosen cleanroom products are available in the right place and in the correct, high end quality for your cleanroom and clean zones. With our dedicated account managers, fully qualified products and documented processes, we are your expert partner for your critical contamination control.
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In addition, we know that most of the pharmaceutical industry follows EU GMP (Eudralex Volume 4) and more specifically for their aseptic/sterile productions, its Annex 1, which revision is published 25th august. In this revision, among many others, a section on the specialised washing process of reusable clothing for contamination controlled environments, was added. The Chapter 7, paragraph 17 stipulates that garments in clean areas must be cleaned in a specialised laundry, with a qualified process, ensuring that the garments are not damaged and/or contaminated by fibres or particles during the laundry process. At all our Elis cleanroom laundries we use Helmke drum test as a part of our particle monitoring program, and all processes in our Elis cleanroom laundry is carried out by our highly skilled and trained operators. For instance we have the most trained eyes placed at the packing area, this to ensure best possible inspection of all textiles leaving your Elis cleanroom and secure the products you receive from Elis cleanroom is in comply with Annex 1.
Many international companies trust us for the process of their cleanroom garments : Click here to find out why (link to text call Elis Cleanroom - Your advantage with us as partner).
With many years of experience and a dedicated team of professionals, we developed a large range of products. You should not make compromises when you are looking for a contamination control partner. Our solutions include garment rental and maintenance, mats and cleaning systems, smart cabinets and in-house tracking possibilities of all textiles. Moreover, we can offer you our best solutions to meet your requirements of Annex 1: goggles, socks, shoes, covers, undergarments etc.
Our cleanroom garments, are designed according to the IEST-RP-CC003.4 recommended practices and allow you to operate within the standards associated with your cleanroom, whether it is classified as a Cleanroom ISO 4/5, ISO 7/8 or uncontrolled environment (CNC).
A cleanroom is a room in which the number of particles is controlled, and which minimises the risks of introduction and retention of these particles. At Elis Cleanroom, our teams have a detailed knowledge of the sector and can advise you in your approach and simplify your daily life. Whether you are active in the pharmaceutical industry, electronic production, life sciences… we have a full range of garments, footwear, cleaning systems, and logistics all adapted to your sector of activity for you. We also take care of the collecting, washing, sterilisation, packaging, and delivery of your items so you can concentrate on your core business. We are your contamination control partner.
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