Anyone who thinks that sewing is a somewhat antiquated craft has not yet seen Artivion’s new production facility in Hechingen. The company expansion, which will go into operation in 2022, radiates modernity on every one of its almost 6,000 square meters.
The centerpiece of the facility is a 1500 square meter clean room system in which stent prostheses for minimally invasive vascular surgery are produced in a mixture of high-tech and traditional craftsmanship. The implants consist of textile tubes onto which stiffening wires are sewn – by hand, as no machine can do this yet. The stent prostheses are later inserted minimally invasively into the aortas of patients suffering from aneurysms. Implanted precisely, they prevent a life-threatening rupture of the arteries. At the specialized site in Hechingen, up to 190 seamstresses (mostly women) can now produce these implants in shifts according to a prosthesis plan tailored to the individual patient.
Production under clean room conditions
Florian Tyrs, one of the two managing directors in Hechingen, was involved in the development of these special implants. You can sense his enthusiasm when he talks about the products:
“We have been producing these patient-specific solutions, which are sewn by hand, for 10 years. No machine can do that yet. Of course, this involves an enormous amount of manpower, but it allows us to deliver a highly functional product that can be used in vascular surgery without any adjustments or complications. This is truly unique on the market. I am always delighted that our innovative technologies help to save lives.”
The implants are produced and packaged under clean room conditions in order to completely rule out any contamination of the product and the associated risk to patients. The new Cleanroom is the most important element of production and literally a matter close to the young managing director’s heart:
“We had completely reached the limits of our capacity in our old production facility and wanted to strengthen our location with the new building and continue and expand our expertise in medical technology. We really thought big and planned for the future. The clean room production area of more than 1500 square meters is the heart of the facility. We have attached great importance to functional processes and the latest technology and are very pleased with how the production conditions have improved. We can now deliver even better quality and have significantly fewer rejects.”
Self-supporting construction with walk-on ceiling
Schilling Engineering, also based in Baden-Württemberg, was commissioned to plan and install the entire cleanroom technology. The company specializes in supplying cleanrooms that meet the exact requirements of the processes and conditions. For the medium-sized company, the order from Artivion was the largest order in its history to date.
Ute Schilling, Managing Director of the family business, remembers:
“The order from Artivion was something very special. The layout was optimized and specified according to Artivion’s product and process flow. As a result, Cleanroom focused on the requirements and dependencies of the 22 rooms with the local conditions. The production area was to be retained in its entirety and at the same time no changes were to be made to the building structure of the hall. The technical implementation was examined in an engineering process, the air conditioning technology was designed and the installation location for the technology with maintenance accessibility was planned. The result was an accessible technical level above the airlocks, which does not require a steel structure and the entire production area could be approved.”
The cleanroom facility is completely self-supporting and consists of 22 rooms, which are divided into 12 work areas, 2 offices, personnel and material airlocks and one technical and one cleaning room. The entire area is designed for cleanroom class ISO 8. 126 filter fan units clean the air in a recirculation process to keep harmful particles away from the sensitive processes.
Effective infiltration
A particular planning challenge was the effective integration of the large number of employees. More than 250 people are employed in shifts for the various tasks within the cleanroom. The staff had to be able to arrive at their laminar flow cabinet without waiting times and within a time window of just 20 minutes. In the final solution, three large personnel airlocks were planned, which lead to a shared corridor between the personnel airlocks and the work areas. 16 roller shutters and 12 sliding doors allow convenient and safe access to the individual areas via contactless angle switches.
In addition to the functional processes, Artivion has also paid attention to a good working atmosphere within the cleanrooms. Florian Tyrs comments:
“The production of our stent grafts and the associated minimally invasive insertion systems requires individual work steps that need to be coordinated with each other. This is why we have planned various rooms in the cleanroom facility in which individual teams work. Smaller units are also conducive to the working atmosphere. That was very important to us. The cleanrooms are bright and, above all, run quietly and with little perceptible draught. We have had very positive feedback from our employees so far. The working conditions have improved significantly compared to our old Cleanroom.”
Air conditioning and dehumidification
The actual purpose of a cleanroom system is, of course, the safety of the end product. All the air is exchanged 20 times per hour in the cleanrooms and the interfering particles are transported out of the room with a laminar flow. This ensures compliance with the cleanroom classification at all times and enables the certified process required for the manufacture of medical technology products.
In addition to cleanliness, air conditioning with temperature and humidity control must also be guaranteed. The majority of the clean rooms, which can accommodate up to 95 sewing stations, are operated at a temperature of 21 degrees Celsius and a relative humidity of 55%. In addition, a special “coating” work area requires a particularly high level of dehumidification, as the coating solution used there reacts to moisture. This clean room area is operated at a maximum relative humidity of 35% with its own ventilation unit.
In another work area, the finished implants are loaded into minimally invasive disposable insertion systems. To ensure that they function properly, these mechanical parts must be oiled and double sterile packed at Cleanroom. To meet these requirements, Schilling Engineering supplied special extraction hoods and material locks made to the size of the instruments.
Ute Schilling describes the requirements that her team had during the planning phase:
“The overall planning of the cleanroom system was very complex. At times, ten of our engineers worked on the project simultaneously in order to implement the requirements in the detailed design and meet the ambitious schedule of 10 months between ordering and qualification ”
Timely delivery in five stages
Delivery and installation was planned by the cleanroom company in five stages, so that Schilling Engineering was able to pre-produce the components for the next stage as finished kits during the installation of one stage. Four air conditioning units were installed on the walk-on upper ceiling of the airlock area for the complex air conditioning system. Another main air conditioning unit is located outside the building. In addition, there is fine control for individual rooms via 9 decentralized ceiling units. The clean room system was qualified in accordance with GMP specifications and equipped with remote maintenance and monitoring by Briem. The Cleanroom for the production of the products was subsequently approved and audited by DEKRA.
The young managing director is visibly proud when she looks at the complex system in which one tooth meshes with another:
“We are very proud that we were able to implement the project with the qualification in the desired time frame under the difficult conditions of the pandemic situation, such as supply bottlenecks and staff shortages. I would like to take this opportunity to thank Artivion for their excellent cooperation. We were able to overcome the challenges together thanks to their support and fast communication channels.”
