Fraunhofer Purity Technology Award Reiner! awarded in 2019

Purity Technology Award Reiner! (© Fraunhofer IPA / Photo: Rainer Bez)

DP system from the outside. (© F. Hoffmann-La Roche)

DP system from the inside. (© F. Hoffmann-La Roche)

Udo Gommel, Fraunhofer IPA (second from the right), and the award winners from left: Edward Becker, Hydroflex Group GmbH; Udo Gommel, Fraunhofer IPA; Markus Stübchen, F. Hoffmann-La Roche; Carsten Moschner, Dastex Reinraumzubehör GmbH & Co. KG. (© Fraunhofer IPA/Photo: Tobias Herbst)

Filter test stand for measuring particle retention capacity. (© Fraunhofer IPA/photo: Tanja Eisermann)

The disposable mop is made of polyester microfiber and is available in combination with various agents. (© Hydroflex)

Formerly Clean!, now Reiner! The Fraunhofer Purity Technology Award was awarded for the first time under the name Reiner! at Lounge 2019 in Karlsruhe. The first innovation award went to F. Hoffmann-La Roche for the use of robotics in controlled environments and the design of a suitable drug product (DP) plant. Thetex and Hydroflex Group share second place with equal points. Thetex was distinguished by a filter test stand for cleanroom textiles under realistic stress conditions, while Hydroflex scored with a sterile and pre-dosed cleanroom mop.

First Prize: Building the Customized Future DP Plant

With their idea to use highly automated and robotic systems that minimize human intervention in the aseptic area, F. Hoffmann-La Roche convinced the jury. Facing a changing portfolio shifting towards smaller batch sizes and simultaneously increasing order volume, the company is working on designing a production facility tailored to these requirements. A sterile filling isolator will be the centerpiece on the way to the future DP plant. The glove-free robotic system offers a complete filling and sealing process from inserting the primary packaging into the tubs to unloading the filled and sealed vials or syringes. The entire filling and sealing process occurs without employee intervention. The filling cell offers new possibilities and requires a redesign of procedures that have been established for decades. The DP plant is intended to support this by standardizing individual manufacturing modules across networks and locations.

Second Prize: Filter Test Stand for Cleanroom Textiles

Cleanroom clothing provides special protection because it remains the only filter between humans and the product. Until now, there was only one established test stand in Europe. Originally designed for reverse testing to protect the wearer from environmental risks or workplace hazards, this test stand can now measure particle retention in both directions. Two fundamental parameters are worth improving in the existing test stand: the concentration on the raw gas side and the differential pressure between the pure and contaminated sides. Thetex addressed this issue and developed a new test stand to measure particle retention against airborne contaminants. The raw gas side was defined based on typical values related to human particle emission. The differential pressure between the test sides was reduced accordingly. Additionally, influencing factors during the measurement, such as static charge, were identified and adjusted so they no longer have a direct impact on the results.

Second Prize: Disposable Mop with Integrated Disinfectant

With their cleanroom mop, Hydroflex makes cleanrooms safer and more user-friendly. The disposable mop is made of polyester microfiber and is available with various disinfectants. These include alcohol-based, biocidal, sporicidal disinfectants, as well as neutral cleaners. The user can quickly access a ready-to-use, properly dosed mop. Prior to this development, cleaning and disinfection were only performed after elaborate preparation, which involved preparing a liquid and soaking the dry mop. Now, the cleanroom mop can be used without access to ultrapure water. The risk of contamination spread and material wear from multiple uses is reduced by using the disposable mop.

About the Reiner! Purity Technology Award

The purity technology production is considered a key technology driving important innovations across industries. Manufacturing microchips, flat screens, implants, pharmaceutical active ingredients, or micro- and nanoproducts would be unthinkable without a clean and pure manufacturing environment. Outstanding ideas in purity technology enable entirely new products and make production processes more economical. The Reiner! Purity Technology Award recognizes such developments.

The winners are selected by independent jurors from Fraunhofer, VDI, ESA, Lucerne University of Applied Sciences, and GMP cleanroom technology. The award is an honorary prize not associated with monetary rewards. The recipients can use it as a reference with potential customers and partners. Since this year, the Fraunhofer Purity Technology Award has been presented under the name Reiner!.