Intensively tested and found to be good

Sophia Laboratories S.A, Jalisco

Sophia Laboratories S.A, Jalisco

Advanced Polymers, Inc. in Salem

Advanced Polymers, Inc. in Salem

Ries Pharmacy, Nördlingen (© Oliver Heinemann)

Ries Pharmacy, Nördlingen (© Oliver Heinemann)

Highest purity and hygiene are a must here: Both in the pharmaceutical and medical technology industries, quality assurance is of great importance. After all, quality deviations can have direct impacts on consumers' health. To ensure flawless and consistently high product quality, international standards apply here. These are defined in the GMP guideline (GMP = Good Manufacturing Practice) as an annex to the Medicinal Products and Active Substances Manufacturing Regulation. Among other things, it includes hygiene guidelines as well as criteria for the use of materials in sensitive production environments such as cleanrooms. The requirements for floors in these manufacturing areas are low particle emissions, freedom from cracks and open joints, and very good cleaning and disinfection properties. Selected Nora flooring systems made of rubber have been tested for this purpose by the Fraunhofer Institute (IPA), and their suitability for GMP-A areas as well as areas according to ISO 14644-1 up to class 2 have been certified. Due to their high resistance to biological contamination, chemicals, and disinfectants, Nora floors are the ideal solution for GMP areas.

Low maintenance costs and increased safety

Also, Sophia Laboratories S.A., a globally leading manufacturer of medications in the field of ophthalmology, was looking for a flooring system for their new production facility in Jalisco, Mexico, that fully meets these high requirements. In advance, the responsible persons tested several types of flooring for their chemical resistance, durability, and maintenance costs. After intensive testing – some of the examinations lasted a year – the choice fell on Noraplan Sentica Ed by Nora Systems. The rubber floor perfectly meets the requirements that Sophia Laboratories set for a new GMP floor.

The low maintenance costs of Nora flooring systems were also decisive for the American medical device manufacturer, Advanced Polymers, Inc., in Salem, New Hampshire. "In addition, the ergonomic comfort of Nora floors and their health compatibility played a major role for us," emphasizes Managing Director Mark Saab. "The well-being of our employees is extremely important to us." Nora flooring systems contain no plasticizers (phthalates) or chlorinated organic compounds, thus contributing to healthy indoor air quality. In the company's new production building, Noraplan Mega and Noraplan Astro in blue and gray tones are now in use.

When constructing its new production facility for cytostatics in Nördlingen, Bavaria, the pharmaceutical manufacturer Ries-Apotheke also relied on Nora flooring systems. The cleanrooms were equipped with Noraplan Signa Ed. These convinced with their optimal ESD protection for sensitive electronic devices in the laboratories. In the logistics area, where floors must withstand particularly high dynamic loads, the extremely wear-resistant Norament 926 Grano is used. "We deliberately chose Nora floors for this demanding project because they meet all requirements such as high abrasion resistance and smooth, dense surfaces, and also have excellent cleaning and disinfection properties," says Norbert Bias from the planning Munich architecture firm Bias & Philipp.

Tests and individual on-site consultation

Depending on the specific conditions on site, planners and users can choose from a range of Nora floors in various designs, dimensions, and technical properties. Nora systems offers conductive "ed" qualities for technical rooms, ESD protection zones (EPA), and other areas where processes, products, and components need to be protected from electrostatic discharge. The Nora experts provide product recommendations and support customers with individual, tailored advice for each project: The relevant purity parameters of the respective process environment where Nora flooring systems are used are coordinated with QA managers. Creating detailed calculations of the specific wheel load of the installed floor conveyors and conducting various media resistance tests, either in the Nora laboratory or directly on-site, are also part of the service – a support that users and production managers worldwide appreciate.