The move to our new building has given us 400 square meters of clean room and laboratory space in addition to new office space. Meanwhile clean room and laboratories are part of our daily work, the production environment is qualified and almost all processes are established.
Time to take a short look back at the exciting time of planning and building the infrastructure. We talked to our Head of Manufacturing, Dr. Tim Hösel, who was in charge of the cleanroom construction project.
What are the requirements to CorTec’s clean room?
In the clean room at CorTec different products with different components have to be built efficiently. These might be electrodes, but also encapsulations of active implants or accessories.
In pre-clinical research or for the development of new products, it must be possible to test ideas quickly. This may not affect the serial production of medical grade products.
All these requirements must be reflected in the layout of the room. This means that we need different environmental conditions for different processes in terms of temperature, room humidity, particle count, microbial contamination and so on.
What did the planning phase look like? What had to be paid particular attention to?
The planning was based on our products. We first asked ourselves which products we wanted to build in our production environment and which processes were involved. The product variety at CorTec is very high, because we build many products on specific customer requirements. But the manufacturing processes are permanent.
The next step was to arrange the processes and the associated material process flow spatially next to each other, in order to create a coherent workflow and to ensure that the right environmental conditions prevail at each workstation.
After we had defined the room layout with the required ambient conditions, we then went on to plan the infrastructure such as airlocks for material and personnel, the routes for the technology between the clean room and the plant control center.
What were the challenges during realization?
During implementation, we wanted to translate the defined process paths to the given clean room footprint. At the same time, the challenge was to keep the structure flexible enough to allow us to change the room layout if necessary. In addition, the 100 square meters of laboratory space should be convertible into additional clean rooms whenever this will be required. In cooperation with our cleanroom planner we found many good solutions here.
Parallel to the construction of the cleanroom facilities, the procurement of the equipment was carried out. We set up a task force for this purpose: Colleagues from the development department, who are highly experienced with individual process steps, were involved at an early stage to identify the demand for machines, their technical infrastructure requirements and possible solutions.
Delivery and installation of the machines was a very big challenge against the background of our time schedule: 13 trades worked concertedly in parallel on the clean room. The delivery and installation of the machines had to fit exactly into this work schedule. The installation of the washing machine for example had to be coordinated with the trade who was responsible to build the wall and another one who installed the ultrapure water. They had to work at particular points in time shortly before and shortly after installation of the machine.
What had to be done for the qualification? How has this been mastered?
Here we were initially faced with the big question of whether we should tackle the qualification ourselves or commission a service provider to do it. In the end we decided to do it ourselves for various reasons. Our last QM audit with TÜV-Süd, in which clean room and hygiene were a focus of attention, confirmed that the path we chose was the right one.
Qualification is basically about formulating the requirements for the functionality of the infrastructure and verifying that these requirements are met by the set up the specific facility. In addition, the factor that machines and people work in the cleanroom and thereby influence the infrastructure must also be taken into account.
We have mastered this through great teamwork between the experts for the different processes in our team and our cleanroom planner. We received important input for the preparation of the flow charts and the definition of planning, testing and documentation from Alexander Mayr, member of our Scientific Technical Advisory Board. He has been responsible for implant production at the cochlear implant manufacturer Med-El in Innsbruck for many years and has set up several cleanrooms there.
What is now technically possible in the clean room?
Our clean room enables us to run a continuous manufacturing operation for research products as well as for medical devices considering all regulatory requirements. Apart from that also accessories can be manufactured.
What remains to be done?
Not all processes have been completely transferred yet. Work is still underway to consolidate everything at the new location. The construction of a second production line for electrodes is already being discussed.
In addition, we are constantly collecting feedback from our day-to-day work and improving the processes and the room layout. The clean room is therefore constantly in motion in a double sense.