Cleanroom

What is a Cleanroom ?

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.

Your cleanroom laundry

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.

https://www.youtube.com/watch?v=TlNWJQecuzo

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).

Cleanroom Sub branches

Elis Cleanroom - life science production

Life Science

Life science industry and cleanroom process

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Elis Cleanroom pharmaceutical industry

Pharmaceutical industry

Everything to know about pharmaceutical industry and the GMP

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Elis Cleanroom micro electronics

Electronics production

Main elements to know about electronics and micro electronics production

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Elis Cleanroom - rechargeable and lithium battery

Rechargeable and Lithium Battery Market

The need of ESD product for the rechargeable and lithium battery market

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Overview

 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.

Elis cleanroom solutions and product

Our cleanroom solution

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).

  • To prevent contamination coming from your operators

    As people are the main cause of contamination, our mutual goal is to both protect the product from the people and the people from the product in some cases. Elis Cleanroom can offer you for the protection of the operators, special PPE cleanroom solutions. After discussion with your dedicated teams we provide a cleanroom clothing concept tailored to your needs, be it for undergarments such as tunics or trousers, or for cleanroom uppergarments such as coveralls, cleanroom footwear, headgear or lab coats. Various regulations including GMP, DIN EN ISO recommend the use of eye coverings for your ISO 4/5 cleanroom (or Grade A/B environment). When choosing your goggles, multiple criteria must be considered: no skin exposure, easy and aseptic gowning, comfort, adjustment to fit, and lack of fogging. We save you the investment in expensive cleaning, decontamination, and sterilisation systems for your cleanrooms. Elis Cleanroom takes care of it for you, and we are at your side to advise you in your choices

  • To prevent the contamination coming from the floor

    We offer a range of footwear, suitable for use in cleanrooms, including cleanroom overboots, cleanroom safety shoes, clogs and dedicated socks. As contamination can come from the private shoes, feet and the floor, it is important to use footwear that is qualified for your cleanroom  and clean area’s. In addition, cleanroom socks provide an extra barrier against human contamination.

    To minimise cross contamination, we developed our multi usable Flexi Mat which traps particles coming from the soles of clogs or shoes as you walk across it. Cleanroom Flexi Mat is used in controlled environments, especially at transitions, such as airlocks in cleanrooms. The Flexi Mat it not only providing a visual transition between different areas, but it also minimises the undesirable spread of contaminants.  

  • To prevent contamination coming from surface

    Every facility and every room requires different cleaning protocols as effective cleaning and contamination control is essential to the functioning and efficiency of the cleanroom in which your products are produced. This starts with the choice of the right cleaning system. To meet your specific cleaning needs we have developed various cleaning systems to keep your cleanroom both clean and contamination free. We have systems which can clean walls, floors and ceilings, but they can also clean insulators, pipes, tanks. We also offer launderable microfibre wipes that remove 99.99% of bacteria.

  • To facilitate your everyday life

    To help you with your logistics, we offer various products, such as reusable autoclavable bags, which are available as both standard and custom sizes and allow you to sterilise your material without the risk of tearing them during the autoclave process. We are continuously developing Elis Connect, an online dashboard that allows you to know in real time what items you have in circulation, what stock is available and whether your operators are following your SOP. In addition, we have Smart solutions, to store and vend your garments.

In brief

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.