In ISO standard cleanroom environments in the pharmaceutical, life sciences and manufacturing industries, airborne particles can be a major source of contamination. Not only can they cause yield loss, the particles can also lead to corrosion and product degradation. ISO standards and CGMP regulations for air purity require compliance by presenting consistent results that can be verified on a regular basis.
Because of these requirements, we recommend our Colorex and Sphera SD/EC ranges. Suitable products are Colorex SD, Colorex EC, Colorex Plus EC, Sphera SD and Sphera EC.
Sphera SD | EC is our homogeneous vinyl collection with conductive properties in sheet format. The collection is specifically designed to control static discharges and particles in the most sensitive environments.
Available in both SD and EC performance options, Sphera SD | EC ensures the highest hygienic properties and provides permanent ESD control.
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Ideal for cleanrooms
Colorex satisfies the strictest requirements for particle release behaviour, helping to reduce any threat of contamination. What’s more, following a comprehensive programme of testing, its suitability in ISO standard cleanroom applications has been certified by the renowned Fraunhofer IPA Institute in Germany.
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The cleanroom suitability certification of Colorex actually consists of two independent qualifications:
The CSM qualification, which defines the suitability of Colorex EC for a specific cleanroom class, based on particle release and outgassing behaviour. This is the main qualification for pharmaceutical cleanrooms.
The TESTED DEVICE certification, where the action of chemical and biological stresses on Colorex EC, as well as its decontamination capabilities, have been assessed. This test series will be typically dedicated to the pharmaceutical industry, to life science applications and to healthcare in general.
CSM stands for Cleanroom Suitable Materials. CSM is an industry alliance that was initiated by the Fraunhofer IPA institute in 2003. The CSM alliance develops testing methods based on international standards dedicated to assess and validate the cleanroom suitability of anything that is used or is entering a cleanroom environment. Today, some 30 leading names of the contamination control industry worldwide are part of the alliance. Forbo Flooring Systems joined the CSM alliance in 2009.
The qualification highlights of Colorex EC are:
● Airborne particle emission test and cleanroom suitability (ISO 14644-1)
● Outgassing analysis and classification (ISO 14644-8)
● Adhesion of micro-organisms
● Assessment of microbial metabolic potential (ISO 846)
● Chemical resistance (ISO 2812-1)
● Cleanability rating (VDI guideline 2083 Pat 4)
● cGMP classification complying to Class A
Colorex SD is a static dissipative homogeneous floor covering in tile format with permanent ESD properties. Because of the dense network of dissipative veins, static charges flow easily through the floor to earth. Colorex SD tiles can withstand the most demanding conditions and offer a perfect solution for highly sensitive areas such as cleanrooms, and for demanding production sites in the electronics, life sciences and manufacturing industry.
Colorex EC is an electrostatic conductive floor covering in tile format with permanent ESD properties. Because of the dense network of conductive veins, static charges flow easily through the floor to earth. Colorex EC tiles can withstand the most demanding conditions and offer a suitable solution for highly sensitive areas such as cleanrooms and for demanding production sites in the electronics, life sciences and manufacturing industry.
Colorex Plus is a high performance floor covering system consisting of adhesive free tiles for all applications areas where expensive sub floor preparation or downtime is an issue. Colorex Plus can be installed without disruption of activities and it can be used immediately after installation, even by fork lift trucks. Colorex Plus is available as electrostatic conductive (EC) option, a basic option and an enhanced slip-resistance option (R10).
Sphera SD is a homogeneous sheet vinyl floor covering with static dissipative properties. To ensure consistent, reliable performance, dissipative chips have been added. The clean sabbia embossing structure provides an easy to clean, matt surface.
Sphera EC is a homogeneous vinyl flooring with electrostatic conductive properties. To ensure consistent, reliable performance, carbon black chips have been added. The marbled design chips soften the appearance and provide an authentic look. The 13 colours have an easy to clean and matt surface thanks to the clean sabbia embossing structure.
Marmoleum Ohmex is a linoleum floor covering that meets higher requirements for electrical conductivity. It's electrical resistance is improved to < 1-108Ω (in accordance with EN1081).
This ensures personal safety and protects equipment that is sensitive to static electricity, like computers and other electronic devices.