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Cleaning surgical Instruments – introducing an all-new Process

Clean surgical instruments in individual, cascaded small basins and then dry them by hand with a compressed air gun: This leads to the desired cleaning result, but is it economical and reproduceable?

Elma Schmidbauer Suisse AG
Mägenwil, Switzerland

Reproducible results for medical technology - the cleaning process makes all the difference!

From the moment of clarity to the best reproducible results
Cleaning surgical instruments in individual, cascaded small basins and then drying them by hand with a compressed air gun: this also leads to the desired cleaning result. However, according to Markus Lutter, Head of Workshop and Production at Gebrüder Zepf Medizintechnik, this has not been economical for some time: the personnel costs are too high and the process of manually switching from one basin to the next is too time-consuming. Especially as more and more instruments are being given a wear-resistant coating after production.

The time had come for Markus Lutter and authorized signatory Markus Lippoth to take action when tests with a more thorough pre-cleaning of the stainless steel components after the machining process led directly to better coating results. A moment of clarity and the reason to completely redesign the cleaning process. It needed to be compact, user-friendly and flexible for use with a wide range of products. And deliver the best reproducible results. As Managing Director Tobias Zepf explains: "Cleaning plays an essential role both in terms of our own quality standards and for the conformity of our entire process chain with the requirements of the European Medical Device Regulation. Since 2020, our products have been categorized in the higher risk class Ir for reprocessable surgical instruments. This entails increased requirements that did not previously exist."

Everything in flow with the MAFAC JAVA
Gebrüder Zepf Medizintechnik opted for a MAFAC JAVA in order to meet the aforementioned requirements and also to ensure an uninterrupted production run. Firstly, because the premium instruments can be cleaned gently and highly efficiently thanks to the rotation of the basket holder and spraying system. Secondly, says Markus Lutter, "all steps now run compactly and reliably in one system. The MAFAC JAVA is integrated into the production run to save space and is so variable that we are really well positioned for the future." 

According to Thomas Gutmann, Head of Customer Support at MAFAC, this variability makes a positive difference not only in sensitive medical technology, but in all user industries: "Water-based cleaning with our patented cleaning and drying technologies offers a wide range of parameters that can be set individually and precisely according to the respective specifications. A change of material, a new component, a more complex geometry - the programs already stored can be adjusted accordingly or supplemented with additional ones."

The cleaning process - tested and optimized
Gebrüder Zepf Medizintechnik currently has three programs with a runtime of around 20 minutes for intermediate and final cleaning. In the cleaning phase, the stainless steel components fixed in a tool carrier are cleaned in a sequence of spraying, spray flooding and renewed spraying, the dirt particles are loosened and removed from the process. The components are blown off before the rinsing phase. This lifting process prevents the cleaning medium from being carried over into tank two, which is filled with clear water for rinsing. 

“I am delighted with how precisely the cleaning process can be adapted to our requirements and the possibilities that water-based cleaning offers.”
Markus Lutter, Head of Workshop and Production at Gebrüder Zepf Medizintechnik

In order to achieve absolute dryness before packaging or further processing steps - coating the components and silicone spraying the handles - the drying process is designed in two stages. First, the rotating nozzle system blasts the components with hot, high-purity compressed air and exposes them to hot air, which is also extremely finely filtered. The subsequent vacuum drying process uses negative pressure to ensure that no water residue remains, even in recesses, narrow holes and hard-to-reach areas. “The vacuum process is, if you like, our additional insurance against moisture blooming, water marks or discoloration,” says Markus Lutter.

Authorized signatory Markus Lippoth also rates the investment in MAFAC's cleaning technology positively, as does the cooperation with Thomas Gutmann's team: “The test cleanings in advance and the process optimizations carried out by the MAFAC application engineers after commissioning have more than paid off.”

"Restructuring our cleaning process was exactly the right decision. With the MAFAC JAVA, we are well positioned for the long term and can continue to meet increasing demands with process reliability." 
Tobias Zepf, Managing Director of Gebrüder Zepf Medizintechnik

About Gebrüder Zepf Medizintechnik
Founded in 1949 in Dürbheim near Tuttlingen, in the largest cluster for medical technology in Germany, Gebrüder Zepf Medizintechnik GmbH & Co. KG positioned itself from the outset as a premium supplier of surgical instruments for bone and spinal surgery. The main products in the portfolio today are bone punches in more than 8,000 variants and rongeurs, as well as medical forceps, curettes and endoscopic sheaths. Thanks to the combination of traditional precision craftsmanship and state-of-the-art production methods, individual customer projects can also be realized in smaller quantities. The company, managed by Christoph and Tobias Zepf in the second and third generation, employs 65 people and supplies customers in Germany, Europe, the USA, Japan and Australia. 
More at Gebrüder Zepf Medizintechnik

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