New cleanroom strengthens the competitiveness of Otto Rüttgers GmbH

The construction and implementation of the cleanroom was carried out by item pluspartner PETEK Reinraumtechnik, who relied on the proven profile system from item.

The Otto Rüttgers GmbH in Solingen manufactures scalpel blades and handles that must meet the highest medical technical standards. With the move to a new location, the company established a new cleanroom of class 7, which also reliably meets future regulatory requirements.

A special requirement for the new cleanroom was the integration of a material lock. It ensures that the scalpel blades, after cleaning, go directly into the packaging without contact with the ambient air.

The collaboration proved to be a success: PETEK contributed its specialized cleanroom expertise, while item, as a reliable local partner, ensured continuous support. From left: Stefan Denker, PETEK, and Ralf Eickhorn, item.

Precision and Safety for Sensitive Applications – Otto Rüttgers GmbH & Co. KG manufactures scalpel blades and holders that meet the highest medical technology standards. To ensure the long-term quality of their products and to comply with future legal requirements, the company invested in a new cleanroom. The project was realized together with item plus partner PETEK Cleanroom Technology – based on proven components from the item system building kit.

Otto Rüttgers GmbH & Co. KG, headquartered in Solingen, specializes in the production of scalpel blades and holders and has a company history of over 170 years. As a provider of medical devices, the company supplies medical facilities worldwide. The daily operations are shaped by the highest quality standards and comprehensive regulatory requirements. Otto Rüttgers produces approximately ten million products annually for the international market, with a particular focus on the USA. Managing Director Ralf Zimmermann took over the company in 2020 and is strategically focusing on technological advancement and future-proof production processes.

Project start with clear task distribution

With the move to a new location, Otto Rüttgers GmbH & Co. KG planned the construction of a cleanroom that would not only replace the existing space but also feature a higher cleanroom class (Class 7). The goal was to meet future regulatory requirements and strengthen the company's competitiveness in the long term. The initial contact with item was made during another project. After visiting the item Cleanroom Center (icc) at the headquarters in Solingen, Managing Director Ralf Zimmermann was convinced that he had found the right partner for his project with item. The icc is an exclusive showroom where visitors can see modular cleanroom solutions in action. From walk-in cleanrooms to machine enclosures with live airflow visualization, visitors can experience the versatility of the item system building kit. The showcased solution impressed but was not fully tailored to Otto Rüttgers' individual requirements in its standard version. To enable a customized implementation, item recommended the certified plus partner PETEK Cleanroom Technology GmbH from Radolfzell. PETEK has extensive expertise in cleanroom technology and develops tailored solutions based on item components. The clear task distribution – design and implementation by PETEK, component delivery and technical support by item – was as important to Otto Rüttgers as the proximity of the contact person at item.

Custom cleanroom made from item profiles

For the realization of the cleanroom, PETEK Cleanroom Technology relied on the proven profile system from item. This allows for a stable, flexible, and visually high-quality construction that meets the high standards in medical technology. The basic framework of the cleanroom is entirely made from item profiles, while surfaces, plastic channels, and other specific components were manufactured by PETEK. The new space measures approximately 5.1 meters in length, 4.1 meters in width, and 3.5 meters in height – compactly dimensioned and optimally tailored to Otto Rüttgers' production processes. A partially walk-in ceiling was also integrated to facilitate maintenance of filters and air conditioning units. At the lower area of the room, there is a surrounding gap of about four centimeters between the floor and walls. Through this, filtered air is controlled and exits to the outside, creating a constant positive pressure inside the cleanroom. This reliably prevents particles from entering from outside. The construction of the cleanroom features the item X 8 sealing system: this modular surface fastening system is specially developed for use in cleanrooms and is suitable for both walls and ceilings. By combining a basic profile, aluminum covers, and seals, smooth, easy-to-clean surfaces are created that are free of hard-to-reach gaps. This avoids typical weak points where particles could settle. This aspect is especially relevant in terms of "Good Manufacturing Practice" (GMP). The guidelines issued by the European Commission define strict requirements for production environments and processes in pharmaceutical and medical device manufacturing. The goal is to ensure quality, efficacy, and safety permanently. Cleanrooms must therefore be designed to allow reliable cleaning and control at all times. "We used the item sealing system for the first time in this project," explains Stanislav Klopot, General Manager at PETEK Cleanroom Technology GmbH. "The handling during construction convinced us – and we see great potential for further cleanroom projects." The sealing system is just one example of the versatility of the item system building kit for pure production. It offers a wide range of products specifically developed for cleanroom use. Thanks to its modular design and system flexibility, constructions can go far beyond standard solutions. Every component – from profiles and surface fixings to sealing systems – is well thought out, easy to combine, and allows for individual adaptation to specific requirements. This creates a perfect foundation for implementing customized cleanroom systems and adapting to particular production processes.

Safe production process thanks to material lock

A special requirement for the new cleanroom was the integration of a material lock. It ensures that scalpel blades, after cleaning, are transferred directly into packaging without contact with ambient air. Previously, the blades were cleaned outside the cleanroom in a separate area that also adhered to high hygienic standards. They then pass through the material lock directly into the cleanroom, where automated packaging machines hermetically seal them in sterile foil packages. These consist of a transparent and an opaque foil side, sealed using heat technology. The shortened transport route from cleaning to packaging significantly reduces the risk of contamination. "The material lock was indispensable for us to meet the high requirements for sterile medical products," explains Ralf Zimmermann, Managing Director of Otto Rüttgers GmbH & Co. KG. "This way, we can ensure that our products go directly into sterile packaging immediately after cleaning – a crucial step for quality assurance."

Implementation in close collaboration

The implementation of the cleanroom was carried out in close coordination among all involved parties. While PETEK Cleanroom Technology was responsible for design and manufacturing, the Otto Rüttgers team handled the assembly at the new site independently. To facilitate construction, wall elements and the partially removable ceiling were pre-fabricated by PETEK, then disassembled for transport and delivered to Solingen. Otto Rüttgers placed particular emphasis on reliable support throughout the entire project phase. Here, item demonstrated its strength as an on-site partner, providing quick replacement of missing components and personal support on-site. The assembly proceeded smoothly, and the cleanroom was completed on schedule. "The close cooperation with item was a key success factor for us," emphasizes Ralf Zimmermann. "There was always someone available, and we could rely on immediate support whenever needed."

Result: increased safety and future viability

With the new cleanroom, Otto Rüttgers GmbH & Co. KG now has a production environment that complies with regulatory requirements and allows room for future developments. The high-quality construction from item profiles, combined with the expertise of PETEK Cleanroom Technology, ensures reliable and hygienic processing of scalpel blades and holders. By upgrading from class 8 to class 7 cleanroom standards, the company significantly raised its quality standards and laid the foundation for further certifications. The integrated material lock guarantees a seamless transition from cleaning to packaging and plays a crucial role in the overall process safety.

The collaboration also proved to be beneficial: PETEK contributed specialized cleanroom expertise, while item, as a reliable local partner, provided continuous support. This resulted in a tailored solution that opens new market opportunities for Otto Rüttgers and secures production in the long term. Additionally, the new location offers further future prospects: while production was previously limited to single-shift operation, the cleanroom now provides the basis for a flexible two-shift operation – an important step toward expanding production capacity.