Process development
Developing and enhancing surface treatment methods and processes to meet unique requirements is our passion. As one of the few service and solution providers in the field of ultrasonic cleaning and surface technology, KKS has perfected the development of suitable methods and processes. In this respect, KKS occupies a leading position in today’s international supplier market for medical products. Thanks to our many years of experience as a manufacturer of surface treatment and ultrasonic cleaning systems as well as being a service provider for surface treatment and cleaning, we never fail to find the right solution to achieve optimal surfaces.
We work together with our customers to develop the ideal solution
Research & development – The basis for developing surface treatment processes
Research & development plays an important role at KKS. It comprises constant process optimization and development as well as the development of new technologies.
Our extremely efficient research & development department combines academic knowledge with years of experience in physical chemistry, materials science and surface technology for medical technology and other sectors. Our specialists have access to well-equipped laboratories for process development and analytics.
When developing surface treatment processes, KKS provides particular support to its customers for the treatment and/or cleaning of metal, ceramic and plastic surfaces, especially for medical products. Generally speaking, it is possible to implement and examine developments for new surface treatment processes, surface treatment for new raw materials, process changes or the adoption of new auxiliary or operating materials.
During research & development at KKS, findings from basic research are checked to determine if they are applicable to industrial production. KKS works with renowned universities as well as research and innovation centers to continuously develop and perfect surface treatment processes and methods.
Process development – We meet specific requirements through extensive experience
Regardless of the development stage of your product’s surface process, our R&D team will provide you with the support you need to develop an optimal solution. We support you to define processes for a new surface treatment system or the outsourcing treatment of your products by our KKS Medical Surface Center.
During process development, our R&D specialists define potential process sequences and carry out corresponding process tests. Meanwhile, the existing or newly developed process is refined by adjusting its parameters until the customer requirements are met. There are often already established processes in our Medical Surface Center that can be matched to customer requirements either through process development or by making adjustments to individual process steps or parameters. During process development when designing a system, R&D employees support our systems engineering team to define the optimal process sequence and parameters.
Since KKS develops, implements and operates its own systems for the Medical Surface Center, our customers benefit from a partner who not only is skilled at equipment construction, but can also bring the necessary expertise and experience of operating these kinds of systems to project implementation. An unbeatable combination.
Design Transfer – Transfer of development into production and process validation
Processes are validated in the Medical Surface Center by internal research & development experts in collaboration with process and validation specialists. Thanks to this close, interdisciplinary collaboration, we can carry out custom process validations efficiently and expertly. Surface or cleanliness analyses that have to be carried out during process validation are conducted in independent, accredited laboratories. KKS creates the complete validation documentation for the customer in the case of customer-specific validations. These documents include:
- Validation plan (VP)
- Specification (FS)
- Performance qualification (PQ)
- Monitoring and change management
- Risk analysis (FMEA)
- Traceability matrix (TM)
- Validation report (VR)
In the Medical Surface Center, surface treatment processes are also available with standard validations that are carried out on a worst-case test piece defined by KKS. If these can be used for our customers, surface treatment of the product can be carried out without a customer-specific process validation and existing validation reports can be used to form an integral part of a medical product file / technical documentation.
Successful surface treatment processes from the KKS R&D department
We are continuously developing new surface treatment processes. For instance, KKS has further developed TioDark™ dark anodizing as well as the automatic blasting and etching of dental implants, and industrialized their production processes.
TioDark™ dark anodizing process development
Process development for the dark anodizing of implants and medical instruments. This process increases fatigue strength and reduces abrasive wear of the parts. Processes are industrialized in close collaboration with systems engineering and the Medical Surface Center.
Process development for industrializing the automatic etching of dental implants
Process development for blasting and etching dental implants using an automatic etching system with a direct connection to a cleanroom of cleanroom class ISO 7 for final inspection and packaging. Processes are industrialized in close collaboration with the equipment construction department.