In osteosynthesis operations, parts of a broken or injured bone are repositioned and stabilized. Medartis is one of the world’s leading companies in this field. In close cooperation with surgeons and universities, the Swiss company develops technologies for titanium implants that are unique in this form. The titanium screws and plates are adapted to individual anatomical requirements, have rounded and smooth surfaces and can be optimally positioned during the surgical procedure thanks to the ability to swivel the screws.
Medartis has set itself the goal of using high-precision manufacturing quality to improve treatment options for surgeons and increase the healing and quality of life of patients. The Swiss specialists are very successful with this motto and employ around 600 people worldwide with annual growth of over 10 percent. “Our anatomically precisely adapted titanium plates and titanium screws are used to fix bones during surgical procedures,” explains Andy Schwammberger, Head of Packaging and Labeling at Medartis.
Especially in the case of hand and foot fractures, the freely pivotable and finely adjustable positioning of the screws facilitates patient mobility and regeneration. Schwammberger is responsible for the final packaging in the production process for these sensitive products. The implants are sealed and labeled in clean rooms to ensure error-free and, above all, safe delivery to hospitals and doctors at all times. After all, a product that is inserted directly into the body must fully comply with all hygiene standards. This is stipulated not least by the new EU Medical Device Regulation (MDR), the date of application of which has been postponed but not repealed.
Only packaging under controlled cleanroom conditions can guarantee that the titanium implants leave the factory without any contamination from germs or unwanted particles. As part of its growth, the Basel site has now invested in a new 600 square meter Cleanroom “CleanMediCell” from Schilling Engineering, which meets the requirements of cleanroom class ISO 7 in accordance with DIN EN ISO 14644-1. The Baden-Württemberg cleanroom provider was chosen because it is based near the Swiss border and operates a subsidiary on Swiss territory. However, proximity was not the only decisive factor in this decision. The modular and flexible design of the cleanroom system was particularly convincing. “In terms of space, we don’t have an easy situation for the location of the new cleanroom, which practically had to be built around the existing stairwell,” says Schwammberger. Different ceiling heights also had to be taken into account. “The engineers from Schilling really worked out precisely adapted and functional concepts for us.” In order to make optimum use of the limited space, an existing external wall with a window front was integrated into a class ISO 8 cleanroom zone. For this purpose, the windows were specially sealed and screwed together to achieve the required tightness. Existing electrical ducts were also fitted to the load-bearing pillars between the windows to make them smooth and easy to clean to ensure cleanroom suitability. This meant that the existing building could be used in an extremely space-saving manner.
The titanium implants are manufactured outside the cleanroom and fed in via two material locks, one of which is equipped with roller shutters. Material is transferred between the cleanrooms via two washing systems and 1 m³ material pass-throughs. The status of the airlocks is visualized in colour via LED light displays in the glass. This ensures that the medical plates and screws arrive at Cleanroom free of contamination. There, the individual packaging takes place in a class ISO 7 cleanroom zone and later the labeling in a class ISO 8 cleanroom zone before the products are safely discharged via material airlocks and leave the plant. Three personnel airlocks ensure the functional and safe entry of employees into the various cleanroom zones. At the customer’s request, cleanroom-compatible water dispensers were integrated into two airlocks so that employees do not have to leave the airlock completely to refill their drinks. 78 filter fan units with ULPA15 high-performance filters were installed in the cleanroom system, and over 60 air changes per hour ensure that the clean areas and workstations are supplied with ultra-pure air. The cleanroom system can be flexibly extended and converted thanks to a silicone-free GMP sealing clip system(GMP = good manufacturing practice).
In order to reduce the high energy costs associated with operating a cleanroom, the system is operated using a particularly energy-efficient air recirculation process in which the already cooled air is circulated several times. An individually controlled decentralized cooling system conveys the cold air selectively to the points where heat is generated. GMP-compliant LED light strips provide pleasant and energy-saving lighting. Schwammberger is visibly satisfied with the processes and the function of the cleanroom system: “Thanks to the new cleanroom, we can carry out the washing processes that we previously commissioned ourselves. This allows us to process individual orders much more flexibly and quickly.” With the washing systems, airlock systems, the precise air conditioning technology and the necessary monitoring, the cleanroom system is a fairly complex system, but it is precisely tailored to the customer’s needs.
A special feature of the cleanroom system is the integrated GMP-compliant monitoring. Medartis has opted for this extra level of safety and has not only fulfilled the EN ISO 14644-1 specifications, but also the stricter pharmaceutical GMP requirements. Temperature, humidity and air pressure are constantly monitored and recorded for the required monitoring. The “CR Control” serves as the control system for the Cleanroom and the air conditioning technology, with which all set values, including the air conditioning technology, are regulated and monitored and which is controlled via a central touch display. The control system is connected to an app so that those responsible can call up the status of the system on their smartphone at any time. The qualifications were also carried out in accordance with GMP specifications and meet all requirements.
This article was published: Medical Design 2021-1
