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Low-germ and dust-free packaging of titanium implants - Medartis

Medartis specialises in high-precision implant systems of bone fractures and bone malpositions. In order to guarantee the safety of the products both during production and delivery, the company invested in a 600 sqm clean room from Schilling at its Basel location.

In osteosynthesis operations, parts of a broken or injured bone are put back in the right place and stabilised. 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 even during the surgical procedure thanks to a swivel option for the screws.

Especially in the case of hand and foot fractures, the freely swivelling and finely adjustable positioning of the screws facilitates the mobility and regeneration of the patients. In the production process of the sensitive products, Schwammberger is responsible for the final packaging. The implants are sealed and labelled 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 comply with all hygienic standards without exception. This is stipulated not least by the new EU Medical Device Regulation (MDR), whose date of application has been postponed but not cancelled.

Only packaging under controlled cleanroom conditions can guarantee that the titanium implants leave the factory without any contamination by germs or disturbing particles. In the course of growth, the Basel site has now invested in a new 600 sqm "CleanMediCell" cleanroom from Schilling Engineering, which meets the specifications up to cleanroom class ISO 7 according to DIN EN ISO 14644-1. The cleanroom supplier from Baden-Württemberg was chosen because it has its headquarters near the Swiss border and operates a subsidiary on Swiss territory. But proximity was not the only decisive factor in this decision. Above all, the modular and flexible design of the cleanroom system was convincing. "Spatially, we don't have an easy situation for the location of the new cleanroom, which had to be built virtually 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 there." In order to make the best use of the confined space, an existing exterior wall with a window front was integrated into a cleanroom zone of class ISO 8. For this purpose, the windows were specially sealed and screwed to achieve the required tightness. Existing electrical ducts were also mounted on the supporting columns between the windows with regard to cleanroom suitability - smooth and easy to clean. The existing building could thus be utilised in an extremely space-saving manner.

The titanium implants are manufactured outside the clean room and are fed in via two material locks, one of which is equipped with roller doors. The material is transferred between the cleanrooms via two washing systems and 1 m³ material pass-throughs. The status of the airlocks is visualised in colour via LED light displays in the glass. This ensures that the medical plates and screws enter the clean room free of contamination. There, individual packaging takes place in an ISO 7 cleanroom zone, and later labelling in an ISO 8 cleanroom zone, before the products are safely discharged via material locks 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 lock themselves out completely to refill their drinks. In the cleanroom system, 78 filter fan units with ULPA15 high-performance filters were installed; more than 60 air changes per hour ensure that the clean areas and workplaces are supplied with ultra-clean air. The cleanroom system can be flexibly expanded and converted thanks to a silicone-free GMP sealing clip system (GMP = good manufacturing practice).

In order to reduce the high energy costs caused by the operation of a clean room, the system is operated by a particularly energy-efficient recirculation method in which the already cooled air is circulated several times. An individually controlled decentralised cooling system delivers the cold air selectively to the points where heat is increasingly 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 used to commission ourselves. This allows for a much more flexible and faster processing of the individual orders." With the washing systems, airlock systems, precise air-conditioning technology and the necessary monitoring, the cleanroom system is quite a 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 decided to go the extra mile and not only comply with EN ISO 14644-1, but also with the stricter pharmaceutical GMP requirements. Temperature, humidity and air pressure are permanently monitored and recorded for the necessary monitoring. The CR-Control® serves as the control system for the clean room and the air-conditioning technology, with which all setpoints 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 according to GMP specifications and fulfil all requirements.

This article was published: Medical Design 2021-1

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