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European Hygienic Engineering & Design GroupResearch on hygienic ooring systemsParticle and C emissions, chemical and biologicalresistance, and cleanabilityIn the food industry, a hygienic manufacturing environment is an absolute necessity in order tominimise reject rates due to contamination and ensure low-germ or sterile conditions. Productquality is especially impaired by microorganisms but also by other forms of contamination, suchas particles and chemical residues. Today, some foods are already produced and packagedunder cleanroom conditions in the same way as practised by the pharmaceutical industry.Cleanroom technology guarantees the necessary controlled conditions, fullling air qualityrequirements such as those stated in the EU-GMP Guideline Annex 1 for the manufacture ofsterile pharmaceutical products. In order to minimise contamination risks during manufacturingprocesses, cleanroom environments need to be carefully planned to ensure that no sourcesof contamination will be present during later production. Materials used to make walls, oors,housings, joins and equipment systems need to be taken especially into consideration. Usingthe qualication of industrial ooring as an example, this article describes an assessment andclassication procedure that will help planners to make objective decisions about the choice ofmaterials.Markus Keller and Udo Gommel, Fraunhofer Institute for Manufacturing Engineering and Automation IPA,Department of Ultraclean Technology and Micromanufacturing, Stuttgart, Germany.e-mail: markus.keller@ipa.fraunhofer.deTo create controlled hygienic environments, appropriateroom solutions in suitable locations are needed with minimummicrobiotic base levels. To achieve this, the concentration ofparticles in the air has to be drastically reduced. In a normalurban atmosphere, a particle concentration of 0.5 to 35 billionparticles with a diameter of >0.5 μm is typical per cubic meterair volume. Cost-intensive ltration technology can reducesuch particulate concentrations to less than 3520 particles/m 3 >0.5 μm diameter. This is required, for example, in sterilepharmaceutical manufacturing environments and equatesapproximately to Cleanroom Class International StandardsOrganisation (ISO) 5 in accordance with the cleanroomclassication standard ISO 14644-1. 1 The pharmaceuticalindustry uses its own standard for the production of sterilemedicinal products, which also denes different zones forhygienic manufacturing environments and extends theconsidered contamination sources including particles tomicroorganisms. 2 In the food industry, microbiologicalcontamination is also especially relevant. 3 Particles between10 and 20 μm in size make up the majority of airbornemicroorganisms. 4 Another hygiene-related classicationsystem is based on the so-called “hospital guideline” DIN1946-4. 5 The food industry is currently implementing moreand more of the existing good manufacturing practice (GMP)pharmaceutical guidelines. A targeted reduction in airborneparticles >0.5 μm automatically means a reduction in airbornemicroorganisms. However, in hygienic manufacturingenvironments, additional parameters regarding the materialsused are also of interest chemical resistance, biologicalresistance, cleanability and antimicrobial properties. 6Solutions from other areas:Pharmaceutical industryAs many foods are produced and/or packaged under almoststerileconditions (milk products, meats, beverages), thefollowing section gives some brief background informationabout manufacturing environments in the pharmaceuticalindustry. In the process, many of the aspects mentionedcan be applied directly to manufacturing environments in thefood industry. A cross-industry viewpoint can be very helpfulwhen implementing clean and hygienic manufacturingenvironments because both the pharmaceutical and foodindustries have to combat the same sources of contaminationparticles and microorganisms.EU-GMP GuidelineThe European Commission Guide to Good ManufacturingPractice (EU-GMP Guideline) is implemented as astatutory standard in the manufacture of sterile drugs andother contamination-sensitive products. In Annex 1 of theEU-GMP guideline, a special emphasis is placed on therequirements of hygienic manufacturing environments.Clean zones for the manufacture of sterile productsare graded according to the environmental conditionsrequired. In order to minimise the risk of contaminatingthe product or material concerned with particles ormicroorganisms, each manufacturing process requires acorresponding degree of environmental cleanliness in anoperating state. In order to full operating state conditions,the zone has to be designed to achieve a certain degreeof air cleanliness when in a resting state. The restingstate is the state whereby the entire technical equipment