Precision in medical technology – a new cleanroom for Otto Rüttgers.
How a medical technology company made its production processes fit for the future – with help
from item and item pluspartner PETEK Reinraumtechnik.
Based in Solingen, and with a company history that dates back over 170 years, Otto Rüttgers GmbH & Co. KG specialises in manufacturing scalpel blades and handles. The medical device provider supplies products to medical facilities all over the world. A team of around 35 staff ensures compliance with he very highest quality standards and extensive regulatory requirements on an everyday basis.
Otto Rüttgers manufactures approximately ten million products for the international market every year, with a particular focus on the USA. Having taken over the company in 2020, Managing Director Ralf Zimmermann has his sights set firmly on technological advances and future-proof production processes.
To safeguard the quality of its products on a long-term basis, while also ensuring it meets future legal requirements, the company invested in a new cleanroom – and built it using components from the modular item Building Kit System for clean production. The project was carried out in collaboration with PETEK Reinraumtechnik GmbH, which is a member of the item pluspartner network.
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Key inspiration – a visit to the item cleanroom center (icc)
As part of a move to new premises, Otto Rüttgers was planning to build a cleanroom that wouldn’t just replace the existing one but would comply with a higher cleanroom class (class 7), too. The company also wanted to boost its competitiveness on a long-term basis and ensure it would be able to comply with future regulatory requirements.
“After visiting the item cleanroom center (icc) in Solingen, Zimmermann was confident
that, in item, he had found the ideal partner for his project.”
Otto Rüttgers had initially made contact with item in relation to another project. After visiting the item cleanroom center (icc) in Solingen, Zimmermann was confident that, in item, he had found the ideal partner for his project. The icc is a dedicated cleanroom showroom where you can experience modular cleanroom solutions in action – from walk-in cleanrooms to machine cabins with live air current visualisation – and see the versatility of the item Building Kit System for yourself.
item pluspartner PETEK on board as an additional expert
The standard solution on show was impressive, but not quite a perfect fit for the specific Otto Rüttgers requirements. To customise the cleanroom, we recommended PETEK in Radolfzell. PETEK, which is an item pluspartner, boasts extensive know-how in cleanroom technology and develops tailored solutions based on item components. The clear division of tasks – with PETEK designing and implementing the solution and item supplying the components and providing technical support – was just as important to Otto Rüttgers as the geographical proximity of its contact at item.
Customised medical technology cleanroom made from item profiles
PETEK built the cleanroom using tried-and-tested profile technology from item. This proved perfect for creating a robust, versatile and visually impressive construction that meets the stringent requirements of the medical technology sector. The basic framework consists entirely of item profiles, while PETEK manufactured panels, plastic conduits and other custom components itself.
““The basic framework of the medical technology cleanroom consists entirely of item
profiles, while PETEK manufactured panels, plastic conduits and other custom components itself.””
The new cleanroom is around 5.1 metres long, 4.1 metres wide and 3.5 metres high – compact and perfectly tailored to the production operations at Otto Rüttgers. A walk-on section was incorporated in the ceiling for the purpose of carrying out maintenance work on fan filter units and air- conditioning equipment.
A gap of around four centimetres between the floor and walls running right round the medical technology cleanroom allows the filtered air to escape in a controlled manner and creates a constant overpressure inside. This reliably stops particles getting in from outside the room.
Cleanroom-compatible joins thanks to the modular Fixing System
Fixing System X 8 from item played a key role in the design of the cleanroom. We specifically developed this modular panel fastening system to meet cleanroom requirements, and it is suitable for both walls and ceilings. The kind of smooth, easy-to-clean surfaces that are needed in a cleanroom, with no hard-to-access gaps, can be created by combining base profiles, aluminium covers and seals. Typical weak spots where particles could settle are thus avoided.
This aspect is especially relevant in the context of Good Manufacturing Practice (GMP). The guidelines drawn up by the European Commission define stringent requirements relating to production environments and manufacturing processes in the pharmaceutical and medical technology sectors. The aim is to ensure quality, safety and efficacy on a long-term basis. Consequently, cleanrooms for medical technology must be designed so that reliable cleaning and monitoring is possible at all times.
“This project gave us our first experience of the item Fixing System in action. We were
impressed by how easy it was to use and believe it offers great potential for further cleanroom
projects.”
“This project gave us our first experience of the item Fixing System in action. We were impressed by how easy it was to use and believe it offers great potential for further cleanroom projects,” explains Stanislav Klopot, General Manager at PETEK. The Fixing System is just one example of the versatility of the item Building Kit System for clean production. This system offers a wide range of products that have been developed specially for use in cleanrooms.
Reliable processes thanks to a cleanroom material airlock
One particular requirement for the new cleanroom was the inclusion of a material airlock to ensure the scalpel blades are transferred directly into their packaging after being cleaned, without any ambient air contact. The blades undergo prior cleaning in a separate area outside the cleanroom that is also subject to high hygiene standards.
They are then transferred via the material airlock directly into the cleanroom, where automated packaging machines seal them in sterile heat-sealed foil packs with one transparent and one opaque side. Reducing the distance the blades travel between cleaning and packaging minimises the risk of contamination.
“The material airlock was vital for us to meet the stringent requirements relating to
sterile medical devices.”
“The material airlock was vital for us to meet the stringent requirements relating to sterile medical devices. It means we can ensure our products are transferred into their sterile packaging immediately after cleaning – a key step in terms of quality assurance,” explains Zimmermann.
Perfect implementation thanks to close coordination
The coordination between everyone involved in the cleanroom project was excellent. While PETEK was responsible for the design and manufacturing work, the team at Otto Rüttgers took charge of assembly at the new site.
To make the construction process easier, the wall elements and the ceiling with its walk-on section were prefabricated at PETEK, then dismantled as necessary for transport and delivered to Solingen. Reliable support during the entire project phase was particularly important to Otto Rüttgers. This is where item was able to make the most of its geographical proximity. We supplied any missing components without delay and offered on-site support in person.
“We regarded the close collaboration with item as a key success factor. We were always
able to get hold of someone from the company and could rely on receiving the necessary support
straight away.”
As a result, the assembly process went quickly and the cleanroom was completed on time. “We regarded the close collaboration with item as a key success factor. We were always able to get hold of someone from the company and could rely on receiving the necessary support straight away,” emphasises Zimmermann.
Class 7 cleanroom as the basis for further certifications
Thanks to the new cleanroom, Otto Rüttgers GmbH & Co. KG now has a production environment that meets two objectives – it satisfies the regulatory requirements and also provides scope for future developments. The high-quality construction based on item profiles, combined with PETEK’s expertise, ensures the scalpel blades and handles can be processed both reliably and hygienically.
“The high-quality construction based on item profiles, combined with PETEK’s expertise,
ensures the scalpel blades and handles can be processed both reliably and hygienically.”
By upgrading from cleanroom class 8 to 7, the company has increased its quality standards significantly and laid the foundations for further certifications. The integrated material airlock ensures a seamless transition from cleaning to packaging and makes a key contribution to the reliability of the entire process.
Two-shift operation and new market opportunities
What’s more, the new site offers additional possibilities for the future. Whereas only single-shift production was previously possible, the new cleanroom now creates the basis for flexible two-shift operation – an important step towards increasing production capacity.
The excellent cooperation throughout the project was a real plus. PETEK provided specialised cleanroom expertise, while item reliably ensured continuous on-site support. The result was a custom solution that opens up new market opportunities for Otto Rüttgers and safeguards its production on a long-term basis.
