600 Square Metre Clean Room for Titanium Implants - Verdict Medical Devices
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600 Square Metre Clean Room for Titanium Implants

Medartis AG is specialised in high-precision implant systems for bone fractures and bone malpositions. The Swiss company has now invested in a 600 square metre clean room of the latest standards to guarantee the safety standards for medical products.

Medical products for osteosynthesis

In osteosynthesis operations, parts of a broken or injured bone are brought back into place and stabilised. The Swiss company Medartis is one of the world’s leading companies supplying implants for these surgical procedures. In close cooperation with surgeons and universities, this high-tech company develops technologies for titanium implants that are unique in this form on the world market. 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 swivel capability of the screws. Medartis’ goal is to improve the treatment options for surgeons with high-precision manufacturing quality and to 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 an annual growth rate of over 10%.

Andy Schwammberger, as Head Packaging and Labeling, is one of the specialists in the team of this ambitious Swiss company. Like many of his colleagues, he is enthusiastic about the high-tech products: ” The freely pivoting and finely adjustable positioning of the screws facilitates the mobility and regeneration of the patients. We are giving people back a piece of quality of life”.

Packaging and labelling in modern cleanroom systems

IIn the production process of sensitive products, Andy Schwammberger is responsible for the final packaging. The implants are sealed and labelled in cleanrooms to ensure error-free and above all safe delivery to hospitals and doctors at all times. After all, a product that is used directly in the body must comply with all hygienic standards without exception. This is not only prescribed by the legal requirements of the new EU Medical Device Regulation (MDR) but is also a self-evident quality standard which the Swiss company meets for the benefit of the patients. In the course of growth, the Basel site has now invested in a new 600 sqm CleanMediCell® clean room, which meets the requirements up to cleanroom class ISO 7 according to DIN EN ISO 14644-1. The cleanroom supplier was chosen by SCHILLING ENGINNEERING from Baden-Württemberg, which has its headquarters near the Swiss border and operates a subsidiary on Swiss territory. But not only the proximity was the decisive factor for this decision as Andy Schwammberger remembers:

“We compared several offers for the cleanroom and were very impressed by the quality and above all the modular, flexible design of the CleanMediCell® cleanroom system. For spatial reasons, we did not have an easy situation for the location of the new cleanroom, which had to be built virtually around the existing stairwell. Different ceiling heights also had to be taken into account. The engineers at Schilling really did provide us with precisely adapted and functional concepts. We were also convinced by the alignment of the system to the requirements of medical technology”.

In order to make optimum use of the limited space available, an existing exterior wall with 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 installed on the supporting columns between the windows in a smooth and easy-to-clean manner to ensure clean-room suitability. The existing building could thus be used in an extremely space-saving manner.

Energy-efficient air circulation system

In order to reduce the high energy costs caused by the operation of a clean room, SCHILLING ENGINEERING’s system is operated with a particularly energy-efficient recirculation method in which the already cooled air is circulated several times. An individually controlled decentralised cooling system is used, which, depending on the requirements, selectively transports the cold to those places where heat is increasingly generated. GMP-compliant LED batten luminaires provide pleasant and energy-saving lighting. The Head of Packaging and Labelling is very satisfied with the benefits that the installation of the modern cleanroom system has brought:

“Thanks to the new cleanroom, we can now carry out the washing processes we previously commissioned ourselves. This allows much more flexible and faster processing of individual orders. We are very satisfied with the processes and the functioning of the cleanroom system. After all, with the washing facilities, airlock systems, precise air conditioning technology and the necessary monitoring, the cleanroom system is a rather complex system that must be precisely coordinated. So we were glad to have the support and competent performance of the experts who accompanied us through the entire process right up to qualification”.

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